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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011172-30 | EudraCT Number | ||
| PIB/PET IMAGING | Other Identifier | Alias Study Number |
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The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04360365 10 mg/kg | Experimental |
| |
| PF-04360365 7.5 mg/kg | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04360365 10 mg/kg | Biological | 10 mg/kg every 90 days (5 total doses) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 6 months after last dose (up to 18 months) that were absent before treatment or worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. | Day 1 up to 6 months after last dose of study medication (up to 18 months) |
| Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral edema, cerebral/meningeal enhancement, micro hemorrhage, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyper intensities) were assessed from structural magnetic resonance imaging (MRI). Participants with brain abnormality other than those listed above assessed using MRI scan were reported under 'other' category. Only those MRI findings in which at least 1 participant had event, were reported. | Baseline up to Month 18 |
| Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI) | Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI. | Baseline up to Month 18 |
| Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18 | ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). The total score was calculated as the sum of the scores for the 11 items. ADAS-cog total score ranges from 0 (no impairment) to 70 (maximum impairment). Higher total and individual item scores indicate greater cognitive impairment. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins | Cohort M&Q: Pre dose (0 hr) on Day 0, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30 | |
| Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360 |
Inclusion Criteria:
Males or females of non childbearing potential, age > or = 50.
Diagnosis of probable Alzheimer's disease, consistent with criteria from both:
Mini-mental status exam score of 16-26 inclusive.
Rosen-Modified Hachinski Ischemia Score of < or = 4.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska Sjukhuset, CTC | Gothenburg | 413 45 | Sweden | |||
| Malmo Sjukhus, Neuropsykiatriska Kliniken |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-04360365 10 mg/kg (Cohort Q) | Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months. |
| FG001 | Placebo (Cohort Q) | Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months. |
| FG002 | PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M) | Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months. |
| FG003 | Placebo (Cohort M) | Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS) included all randomized participants who received at least 1 infusion of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-04360365 10 mg/kg (Cohort Q) | Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months. |
| BG001 | Placebo (Cohort Q) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 6 months after last dose (up to 18 months) that were absent before treatment or worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all randomized participants who received at least 1 infusion of study medication. | Posted | Count of Participants | Participants | Day 1 up to 6 months after last dose of study medication (up to 18 months) |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study. Data for adverse events were summarized by cohort as pre-specified in statistical analysis plan; hence, combined data is presented for PF-04360365 10 mg/kg, then PF-04360365 7.5 mg/kg (Cohort M).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-04360365 10 mg/kg (Cohort Q) | Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA v14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C572721 | ponezumab |
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| PF-04360365 7.5 mg/kg |
| Biological |
10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses) |
|
| placebo | Drug | placebo administered every 90 days or monthly to match experimental treatment arms. |
|
Quantitative amyloid imaging was performed using PET technique using [11C] Pittsburgh Compound B (PIB) for following brain areas: frontal, temporal, parietal and occipital cortices, anterior and posterior cingular cortex, cerebellum, pons, and subcortical white matter. For target regions of interest, beta-amyloid plaque imaging radiotracer (PIB) retention data was expressed as standard uptake value ratio (SUVR) which was defined as a ratio of radioactivity uptake of the target region relative to the cerebellum reference region. This outcome measure was planned to be analyzed only for cohort M. |
| Baseline, Month 13 |
| Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour on Day 0 (Day prior to dosing) |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 1 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 1 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 1 |
| Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 10: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 216 hours post dose on Day 1 (samples taken on Day 10) |
| Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 20: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 456 hours post dose on Day 1 (samples taken on Day 20) |
| Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 30: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 30 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 30: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 30 |
| Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 40: Cohort Q | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 936 hours post dose on Day 1 (samples taken on Day 40) |
| Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 50: Cohort Q | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 1176 hours post dose on Day 1 (samples taken on Day 50) |
| Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 60: Cohort Q | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 1416 hours post-dose on Day 1 (samples taken on Day 60) |
| Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 60: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 60 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 60: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 60 |
| Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 90 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 90 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 90 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 90 |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 120 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 120: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 120 |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 150: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 150 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 150: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 150 |
| Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 180 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 180 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 180 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 180 |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 210: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 210 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 210: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 210 |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 240 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 240: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 240 |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 270 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 270 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 270 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 270 |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 300 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 300: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 300 |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 330: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 330 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 330: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 330 |
| Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 360 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 360 |
| Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 360 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0.25 hours post-infusion start on Day 360 |
| Mean Plasma Concentration of PF-04360365 at 720 Hours Post-dose on Day 360: Cohort Q | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 720 hours post-dose on Day 360 (samples taken on Day 390) |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 390: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 390 |
| Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 540: Cohort Q | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hours (pre-dose) on Day 540 |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | 0 hour (pre-dose) on Day 540 |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0 | A-beta is a peptide fragment of the amyloid precursor protein (found in the brain of participants suffering from of Alzheimer's disease (AD). In this outcome, CSF concentration of 3 variants of A-beta were reported: A-beta (1-X), A-beta (1-40) and A-beta (1-42). | 0 hour on Day 0 (Day prior to dosing) |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M | 216 hours post-dose on Day 1 |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M | 456 hours post-dose on Day 1 |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M | 0 hour (pre-dose) on Day 30 |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q | 936 hours post-dose on Day 1 (Samples taken on Day 40) |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q | 1176 hours post-dose on Day 1 (Samples taken on Day 50) |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q | 1416 hours post-dose on Day 1 (Samples taken on Day 60) |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q | 0 hour (pre-dose) on Day 90 |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180 | 0 hour (pre-dose) on Day 180 |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360 | 0 hour (pre-dose) on Day 360 |
| Baseline, Month 3, 6, 9, 13, 18 |
| Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Month 6, 13 and 18 | DAD is a functional assessment based on interview with the caregiver of participants. It consists of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item scored as yes = 1, no = 0 and not applicable= N/A. A total score is obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A are not considered for the total score. DAD total score range from 0 (more dysfunction) to 100 (better function), with higher scores indicating better functioning. | Baseline, Month 6, 13, 18 |
| Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Month 13 | Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total MMSE score ranged from 0 (worst cognitive state) to 30 (best cognitive state), where higher score indicates better cognitive state. | Baseline, Month 13 |
| Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x) | Cohort M&Q: 0 hour(hr) & 0.25 hrs post dose (pd) on Day (D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936,1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D 60, 0 hr & 0.25 hrs pd on D 30,120,150,210,240,300,330 |
| Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40) | Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390,540; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330 |
| Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42) | Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330 |
| Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30 |
| Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360 | Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30 |
| Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360 | Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30 |
| Number of Participants With Measurable Serum Anti-Drug Antibody (ADA) Concentration | A measurable ADA is defined as a serum anti-drug anti body response (total binding assay) greater than the lower limit of quantification (4.32). | Day 1 up to Month 18 |
| Malmö |
| 205 02 |
| Sweden |
| Sahlgrenska Universitetssjukhuset, Minnesmottagningen | Mölndal | 431 41 | Sweden |
| Karolinska Universitetssjukhuset Huddinge | Stockholm | 141 86 | Sweden |
Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months. |
| BG002 | PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M) | Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months. |
| BG003 | Placebo (Cohort M) | Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| PF-04360365 10 mg/kg (Cohort Q) |
Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months. |
| OG001 | Placebo (Cohort Q) | Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months. |
| OG002 | PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M) | Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months. |
| OG003 | Placebo (Cohort M) | Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months. |
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| Primary | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral edema, cerebral/meningeal enhancement, micro hemorrhage, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyper intensities) were assessed from structural magnetic resonance imaging (MRI). Participants with brain abnormality other than those listed above assessed using MRI scan were reported under 'other' category. Only those MRI findings in which at least 1 participant had event, were reported. | Safety analysis set included all randomized participants who received at least 1 infusion of study medication. | Posted | Count of Participants | Participants | Baseline up to Month 18 |
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| Primary | Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI) | Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI. | Safety analysis set included all randomized participants who received at least 1 infusion of study medication. | Posted | Count of Participants | Participants | Baseline up to Month 18 |
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| Primary | Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M | Quantitative amyloid imaging was performed using PET technique using [11C] Pittsburgh Compound B (PIB) for following brain areas: frontal, temporal, parietal and occipital cortices, anterior and posterior cingular cortex, cerebellum, pons, and subcortical white matter. For target regions of interest, beta-amyloid plaque imaging radiotracer (PIB) retention data was expressed as standard uptake value ratio (SUVR) which was defined as a ratio of radioactivity uptake of the target region relative to the cerebellum reference region. This outcome measure was planned to be analyzed only for cohort M. | Per Protocol (PP) analysis set included all participants who had received the study drug infusions consistent with the protocol specified procedures, had successful PET scans at Month 13, and had no major protocol deviations. Only participants in cohort M were planned to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | Standard update value ratio | Baseline, Month 13 |
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| Primary | Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | Pharmacokinetic (PK) analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | Nanogram per milliliter (ng/mL) | 0 hour on Day 0 (Day prior to dosing) |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 1 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 1 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 1 |
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| Primary | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 10: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 216 hours post dose on Day 1 (samples taken on Day 10) |
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| Primary | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 20: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 456 hours post dose on Day 1 (samples taken on Day 20) |
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| Primary | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 30: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure and 'Number Analyzed' signifies participants evaluable for the specified rows. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 30 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 30: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 30 |
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| Primary | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 40: Cohort Q | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every 3 months (cohort Q) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 936 hours post dose on Day 1 (samples taken on Day 40) |
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| Primary | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 50: Cohort Q | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every 3 months (cohort Q) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 1176 hours post dose on Day 1 (samples taken on Day 50) |
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| Primary | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 60: Cohort Q | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure and 'Number Analyzed' signifies participants evaluable for the specified rows. Only participants receiving PF-04360365 every 3 months (cohort Q) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 1416 hours post-dose on Day 1 (samples taken on Day 60) |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 60: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 60 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 60: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 60 |
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| Primary | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 90 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for specified row for each treatment arm, respectively. Only participants receiving PF-04360365 were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 90 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 90 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 90 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 120 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 120: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 120 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 150: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 150 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 150: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 150 |
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| Primary | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 180 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for specified rows for each treatment arm, respectively. Only participants receiving PF-04360365 were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 180 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 180 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 180 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 210: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 210 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 210: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 210 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 240 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 240: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 240 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 270 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 270 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 270 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 270 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 300 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 300: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 300 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 330: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 330 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 330: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 330 |
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| Primary | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 360 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 360 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 360 | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0.25 hours post-infusion start on Day 360 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 720 Hours Post-dose on Day 360: Cohort Q | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 every 3 months (cohort Q) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 720 hours post-dose on Day 360 (samples taken on Day 390) |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 390: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 390 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 540: Cohort Q | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every 3 months (cohort Q) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hours (pre-dose) on Day 540 |
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| Primary | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540: Cohort M | Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method. | PK analysis set included all participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | ng/mL | 0 hour (pre-dose) on Day 540 |
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| Primary | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0 | A-beta is a peptide fragment of the amyloid precursor protein (found in the brain of participants suffering from of Alzheimer's disease (AD). In this outcome, CSF concentration of 3 variants of A-beta were reported: A-beta (1-X), A-beta (1-40) and A-beta (1-42). | Full Analysis Set (FAS) included all randomized participants who received at least 1 infusion of study medication. | Posted | Mean | Standard Deviation | Picogram per milliliter (pg/mL) | 0 hour on Day 0 (Day prior to dosing) |
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| Primary | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | pg/mL | 216 hours post-dose on Day 1 |
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| Primary | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | pg/mL | 456 hours post-dose on Day 1 |
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| Primary | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every month (cohort M) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | pg/mL | 0 hour (pre-dose) on Day 30 |
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| Primary | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every 3 months (cohort Q) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | pg/mL | 936 hours post-dose on Day 1 (Samples taken on Day 40) |
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| Primary | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every 3 months (cohort Q) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | pg/mL | 1176 hours post-dose on Day 1 (Samples taken on Day 50) |
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| Primary | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every 3 months (cohort Q) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | pg/mL | 1416 hours post-dose on Day 1 (Samples taken on Day 60) |
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| Primary | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every 3 months (cohort Q) were to be analyzed for this outcome measure. | Posted | Mean | Standard Deviation | pg/mL | 0 hour (pre-dose) on Day 90 |
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| Primary | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180 | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure and 'Number Analyzed' signifies participants evaluable for specified amyloid beta for each treatment arm, respectively. | Posted | Mean | Standard Deviation | pg/mL | 0 hour (pre-dose) on Day 180 |
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| Primary | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360 | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this measure and 'Number Analyzed' signifies participants evaluable for specified amyloid beta for each treatment arm, respectively. | Posted | Mean | Standard Deviation | pg/mL | 0 hour (pre-dose) on Day 360 |
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| Secondary | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18 | ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). The total score was calculated as the sum of the scores for the 11 items. ADAS-cog total score ranges from 0 (no impairment) to 70 (maximum impairment). Higher total and individual item scores indicate greater cognitive impairment. | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 3, 6, 9, 13, 18 |
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| Secondary | Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Month 6, 13 and 18 | DAD is a functional assessment based on interview with the caregiver of participants. It consists of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item scored as yes = 1, no = 0 and not applicable= N/A. A total score is obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A are not considered for the total score. DAD total score range from 0 (more dysfunction) to 100 (better function), with higher scores indicating better functioning. | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6, 13, 18 |
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| Secondary | Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Month 13 | Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total MMSE score ranged from 0 (worst cognitive state) to 30 (best cognitive state), where higher score indicates better cognitive state. | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 13 |
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| Secondary | Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x) | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | pg/mL | Cohort M&Q: 0 hour(hr) & 0.25 hrs post dose (pd) on Day (D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936,1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D 60, 0 hr & 0.25 hrs pd on D 30,120,150,210,240,300,330 |
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| Secondary | Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40) | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | pg/mL | Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390,540; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330 |
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| Secondary | Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42) | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | pg/mL | Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330 |
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| Other Pre-specified | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | pg/mL | Cohort M&Q: Pre dose (0 hr) on Day 0, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30 |
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| Other Pre-specified | Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360 | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | gram per liter (g/L) | Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30 |
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| Other Pre-specified | Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360 | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | 10^6 cells per liter | Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30 |
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| Other Pre-specified | Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360 | FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here 'Number Analyzed' signifies participants evaluable for this measure at specified time point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | millimole per liter (mmol/L) | Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30 |
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| Other Pre-specified | Number of Participants With Measurable Serum Anti-Drug Antibody (ADA) Concentration | A measurable ADA is defined as a serum anti-drug anti body response (total binding assay) greater than the lower limit of quantification (4.32). | Safety analysis set included all randomized participants who received at least 1 infusion of PF-04360365. Only participants receiving PF-04360365 were to be analyzed for this outcome measure. | Posted | Count of Participants | Participants | Day 1 up to Month 18 |
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| 2 |
| 12 |
| 9 |
| 12 |
| EG001 | Placebo (Cohort Q) | Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months. | 1 | 6 | 5 | 6 |
| EG002 | PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M) | Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months. | 1 | 12 | 10 | 12 |
| EG003 | Placebo (Cohort M) | Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months. | 0 | 6 | 5 | 6 |
| Urinary tract infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Facial pain | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Tenderness | General disorders | MedDRA v14.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA v14.1 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA v14.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Areflexia | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Cerebral microhaemorrhage | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Disorientation | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA v14.1 | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Other |
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| Baseline: Lateral Temporal Cortex |
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| Baseline: Occipital Cortex |
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| Baseline: Cerebellum |
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| Baseline: Striatum |
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| Baseline: Anterior Cingulum |
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| Baseline: Temporal Medial |
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| Baseline: Posterior Cingulum |
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| Baseline: Pons |
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| Baseline: Subcortical White Matter |
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| Change at Month 13: Frontal Cortex |
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| Change at Month 13: Parietal Cortex |
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| Change at Month 13: Lateral Temporal Cortex |
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| Change at Month 13: Occipital Cortex |
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| Change at Month 13: Cerebellum |
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| Change at Month 13: Striatum |
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| Change at Month 13: Anterior Cingulum |
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| Change at Month 13: Temporal Medial |
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| Change at Month 13: Posterior Cingulum |
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| Change at Month 13: Pons |
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| Change at Month 13: Subcortical White Matter |
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| Plasma |
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| A-beta 1-40 |
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| A-beta 1-42 |
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| A-beta 1-42 |
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| A-beta 1-42 |
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| A-beta 1-42 |
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| A-beta 1-42 |
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| A-beta 1-42 |
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| A-beta 1-42 |
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| A-beta 1-42 |
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| A-beta 1-40 |
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| A-beta 1-42 |
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| A-beta 1-40 |
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| A-beta 1-42 |
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| Change at Month 3 |
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| Change at Month 6 |
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| Change at Month 9 |
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| Change at Month 13 |
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| Change at Month 18 |
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Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. |
| Mixed Models Analysis |
| 0.8801 |
| LS Mean Difference |
| 0.58 |
| Standard Error of the Mean |
| 3.815 |
| 2-Sided |
| 90 |
| -5.79 |
| 6.94 |
| Superiority or Other (legacy) |
| Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. | Mixed Models Analysis | 0.9412 | LS Mean Difference | 0.28 | Standard Error of the Mean | 3.845 | 2-Sided | 90 | -6.13 | 6.70 | Superiority or Other (legacy) |
| Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. | Mixed Models Analysis | 0.7486 | LS Mean Difference | -1.36 | Standard Error of the Mean | 4.223 | 2-Sided | 90 | -8.38 | 5.66 | Superiority or Other (legacy) |
| Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. | Mixed Models Analysis | 0.0534 | L S Mean Difference | 8.18 | Standard Error of the Mean | 4.171 | 2-Sided | 90 | 1.24 | 15.12 | Superiority or Other (legacy) |
| Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. | Mixed Models Analysis | 0.9980 | L S Mean Difference | 0.01 | Standard Error of the Mean | 3.776 | 2-Sided | 90 | -6.29 | 6.31 | Superiority or Other (legacy) |
| Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. | Mixed Models Analysis | 0.4004 | L S Mean Difference | 3.35 | Standard Error of the Mean | 3.958 | 2-Sided | 90 | -3.25 | 9.94 | Superiority or Other (legacy) |
| Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. | Mixed Models Analysis | 0.6685 | L S Mean Difference | 1.81 | Standard Error of the Mean | 4.214 | 2-Sided | 90 | -5.20 | 8.82 | Superiority or Other (legacy) |
| Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. | Mixed Models Analysis | 0.2968 | L S Mean Difference | 4.74 | Standard Error of the Mean | 4.522 | 2-Sided | 90 | -2.77 | 12.25 | Superiority or Other (legacy) |
| Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. | Mixed Models Analysis | 0.7720 | L S Mean Difference | -1.31 | Standard Error of the Mean | 4.494 | 2-Sided | 90 | -8.77 | 6.16 | Superiority or Other (legacy) |
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| Change at Month 6 |
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| Change at Month 13 |
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| Change at Month 18 |
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Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. |
| Mixed Models Analysis |
| 0.2007 |
| LS Mean Difference |
| 11.37 |
| Standard Error of the Mean |
| 8.789 |
| 2-Sided |
| 90 |
| -3.31 |
| 26.06 |
| Superiority or Other (legacy) |
| Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. | Mixed Models Analysis | 0.3152 | LS Mean Difference | 8.90 | Standard Error of the Mean | 0.8789 | 2-Sided | 90 | -5.78 | 23.59 | Superiority or Other (legacy) |
| Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. | Mixed Models Analysis | 0.8071 | LS Mean Difference | -2.20 | Standard Error of the Mean | 8.964 | 2-Sided | 90 | -17.18 | 12.79 | Superiority or Other (legacy) |
| Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. | Mixed Models Analysis | 0.9918 | LS Mean Difference | -0.10 | Standard Error of the Mean | 9.354 | 2-Sided | 90 | -15.72 | 15.52 | Superiority or Other (legacy) |
| Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate. | Mixed Models Analysis | 0.7498 | LS Mean Difference | -3.01 | Standard Error of the Mean | 9.415 | 2-Sided | 90 | -18.73 | 12.70 | Superiority or Other (legacy) |
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| Change at Month 13 |
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Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.
| ANCOVA |
| 0.5132 |
| LS Mean Difference |
| 1.45 |
| Standard Error of the Mean |
| 2.185 |
| 2-Sided |
| 90 |
| -2.27 |
| 5.16 |
| Superiority or Other (legacy) |
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