Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B2571006 | Other Identifier | Alias Study Number |
Not provided
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| Name | Class |
|---|---|
| JANSSEN Alzheimer Immunotherapy Research & Development, LLC | INDUSTRY |
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The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACC-001+QS-21 | Experimental | Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12 |
|
| ACC-001 | Experimental | Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12 |
|
| QS-21 | Placebo Comparator | Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12 |
|
| PBS | Placebo Comparator | Placebo, IM injection, Day 1, month 3, 6, 9, 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACC-001 | Biological | IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function) | Baseline up to 24 months |
| Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data | Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator. | Baseline up to 24 months |
| Number of Participants With Abnormalities in Neurological Examination | Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg. | Baseline up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-a-beta IgG Titer at Specified Visits | Geometric mean of anti-a-beta IgG titer from pre-study through Week 104 | Baseline up to 24 months |
| Anti-a-beta IgM Titer at Specified Visits | Geometric mean of anti-a-beta IgM titer from pre-study through Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 36, 52, 78 and 104. | The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this stuy, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suwa Red Cross Hospital | Suwa | Nagano | 392-8510 | Japan | ||
| Tazuke Kofukai Medical Research Institute Kitano Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25731629 | Derived | Arai H, Suzuki H, Yoshiyama T. Vanutide cridificar and the QS-21 adjuvant in Japanese subjects with mild to moderate Alzheimer's disease: results from two phase 2 studies. Curr Alzheimer Res. 2015;12(3):242-54. doi: 10.2174/1567205012666150302154121. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ACC-001 3 Micrograms +QS-21 | A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12 |
| FG001 | ACC-001 10 Micrograms | A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12 |
| FG002 | ACC-001 10 Micrograms + QS-21 | A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12 |
| FG003 | ACC-001 30 Micrograms | A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12 |
| FG004 | ACC-001 30 Micrograms +QS-21 | A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 |
| FG005 | QS-21 | A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12 |
| FG006 | Phosphate Buffered Saline (PBS) | A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ACC-001 3 Micrograms +QS-21 | A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12 |
| BG001 | ACC-001 10 Micrograms |
| 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 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function) | The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication. | Posted | Number | Participants | Baseline up to 24 months |
|
Not provided
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACC-001 3 Micrograms +QS-21 | A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000603458 | vanutide cridificar |
| C078785 | saponin QA-21V1 |
Not provided
Not provided
Not provided
Not provided
Not provided
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| QS-21 | Other | IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12 |
|
| ACC-001 | Biological | IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12 |
|
| QS-21 | Other | IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12 |
|
| PBS | Other | IM injection, Day 1, month 3, 6, 9, 12 |
|
| Baseline up to 24 months |
| Baseline up to 24 months |
| The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 36, 52, 78 and 104. | The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction. | Baseline up to 24 months |
| The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 36, 52, 78 and 104. | The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMSVerbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit - y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants' observed baseline scores in the study. | Baseline up to 24 months |
| The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 36, 40, 52, 78 and 104. | The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment. | Baseline up to 24 months |
| Osaka |
| Osaka |
| 530-8480 |
| Japan |
| Osaka Medical College Hospital | Takatsuki | Osaka | 569-8686 | Japan |
| Meitetsu Hospital | Aichi | 451-8511 | Japan |
| Ibaraki Prefectural Central Hospital | Ibaraki | 309-1793 | Japan |
| Shonan Atsugi Hospital | Kanagawa | 243-8551 | Japan |
| Kitasato University East Hospital | Kanagawa | 252-0380 | Japan |
| Juntendo University Hospital | Tokyo | 113-8431 | Japan |
| Juntendo Tokyo Koto Geriatric Medical Center | Tokyo | 136-0075 | Japan |
| Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache | Tokyo | 158-8531 | Japan |
| Caregiver request |
|
| Investigator request |
|
| Subject request |
|
| Group home admission |
|
| Caregiver could not attend the subject |
|
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12
| BG002 | ACC-001 10 Micrograms + QS-21 | A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12 |
| BG003 | ACC-001 30 Micrograms | A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12 |
| BG004 | ACC-001 30 Micrograms +QS-21 | A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 |
| BG005 | QS-21 | A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12 |
| BG006 | Phosphate Buffered Saline (PBS) | A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12 |
| BG007 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12 |
| OG002 | ACC-001 10 Micrograms + QS-21 | A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day1, month 3, 6, 9 and 12 |
| OG003 | ACC-001 30 Micrograms | A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12 |
| OG004 | ACC-001 30 Micrograms +QS-21 | A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 |
| OG005 | QS-21 | A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12 |
| OG006 | Phosphate Buffered Saline (PBS) | A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12 |
|
|
| Primary | Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data | Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator. | The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication. | Posted | Number | Participants | Baseline up to 24 months |
|
|
|
| Primary | Number of Participants With Abnormalities in Neurological Examination | Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg. | The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication. | Posted | Number | Participants | Baseline up to 24 months |
|
|
|
| Secondary | Anti-a-beta IgG Titer at Specified Visits | Geometric mean of anti-a-beta IgG titer from pre-study through Week 104 | The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation. | Posted | Geometric Mean | 95% Confidence Interval | Units/mL | Baseline up to 24 months |
|
|
|
| Secondary | Anti-a-beta IgM Titer at Specified Visits | Geometric mean of anti-a-beta IgM titer from pre-study through Week 104 | The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation. | Posted | Geometric Mean | 95% Confidence Interval | Units/mL | Baseline up to 24 months |
|
|
|
| Other Pre-specified | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 36, 52, 78 and 104. | The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this stuy, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment. | Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog). | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 24 months |
|
|
|
| Other Pre-specified | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 36, 52, 78 and 104. | The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction. | Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog). | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 24 months |
|
|
|
| Other Pre-specified | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 36, 52, 78 and 104. | The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMSVerbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit - y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants' observed baseline scores in the study. | Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog). | Posted | Mean | Standard Deviation | Z-score | Baseline up to 24 months |
|
|
|
| Other Pre-specified | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 36, 40, 52, 78 and 104. | The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment. | Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog). | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 24 months |
|
|
|
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | ACC-001 10 Micrograms | A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12 | 0 | 6 | 6 | 6 |
| EG002 | ACC-001 10 Micrograms + QS-21 | A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12 | 0 | 6 | 4 | 6 |
| EG003 | ACC-001 30 Micrograms | A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 3, 6, 9 and 12 | 0 | 6 | 6 | 6 |
| EG004 | ACC-001 30 Micrograms + QS-21 | A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 | 1 | 6 | 5 | 6 |
| EG005 | QS-21 | A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12 | 0 | 6 | 6 | 6 |
| EG006 | Phosphate Buffered Saline (PBS) | A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12 | 0 | 4 | 3 | 4 |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Cholecystitis infective | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Eyelid ptosis | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Duodenal polyp | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Tongue haematoma | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Allergy to arthropod sting | Immune system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
|
| Anxiety postoperative | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Mental impairment | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Abnormal sleep-related event | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Abulia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Disinhibition | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Paranoia | Psychiatric disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Hypertonic bladder | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Nephrocalcinosis | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Aortic calcification | Vascular disorders | MedDRA 15.0 | 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 |
| Abnormal-consistent with AD |
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| Mental Status |
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| Speech |
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| Cranial Nerves |
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| Visual field |
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| Sensory |
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| Motor |
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| Coordination |
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| Gait |
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| Primitive reflexes |
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| Tendon reflexes |
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| Romberg |
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| Week 2 (n=6, 6, 6, 6, 6, 6, 4) |
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| Week 6 (n=6, 6, 6, 6, 6, 6, 4) |
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| Week 10 (n=6, 6, 5, 6, 6, 6, 4) |
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| Week 14 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 16 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 24 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 28 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 30 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 34 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 38 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 40 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 50 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 54 (n=4, 6, 5, 6, 6, 5, 4) |
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| Week 56 (n=4, 6, 5, 6, 6, 5, 4) |
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| Week 66 (n=5, 6, 5, 6, 6, 5, 4) |
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| Week 78 (n=4, 6, 5, 5, 6, 5, 4) |
|
| Week 91 (n=4, 0, 1, 0, 0, 1, 0) |
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| Week 104 (n=4, 0, 1, 0, 0, 1, 0) |
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| Week 2 (n=6, 6, 6, 6, 6, 6, 4) |
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| Week 6 (n=6, 6, 6, 6, 6, 6, 4) |
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| Week 10 (n=6, 6, 5, 6, 6, 6, 4) |
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| Week 14 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 16 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 24 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 28 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 30 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 34 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 38 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 40 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 50 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 54 (n=4, 6, 5, 6, 6, 5, 4) |
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| Week 56 (n=4, 6, 5, 6, 6, 5, 4) |
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| Week 66 (n=5, 6, 5, 6, 6, 5, 4) |
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| Week 78 (n=4, 6, 5, 5, 6, 5, 4) |
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| Week 91 (n=4, 0, 1, 0, 0, 1, 0) |
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| Week 104 (n=4, 0, 1, 0, 0, 1, 0) |
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| Week 26 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 36 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 52 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 78 (n=4, 6, 5, 5, 6, 5, 4) |
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| Week 104 (n=4, 0 1, 0, 0, 1, 0) |
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| Week 26 (n=4, 4, 4, 6, 5, 5, 4) |
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| Week 36 (n=4, 4, 5, 6, 5, 5, 4) |
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| Week 52 (n=4, 5, 5, 6, 5, 5, 4) |
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| Week 78 (n=2, 5, 4, 5, 5, 5, 4) |
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| Week 104 (n=2, 0, 1, 0, 0, 1, 0) |
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| Week 26 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 36 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 52 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 78 (n=4, 6, 5, 5, 6, 5, 4) |
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| Week 104 (n=4, 0, 1, 0, 0, 1, 0) |
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| Week 8 (n=6, 6, 5, 6, 6, 6, 4) |
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| Week 12 (n=6, 6, 5, 6, 6, 6, 4) |
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| Week 16 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 26 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 30 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 36 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 40 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 52 (n=6, 6, 5, 6, 6, 5, 4) |
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| Week 78 (n=4, 6, 5, 5, 6, 5, 4) |
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| Week 104 (n=4, 0, 1, 0, 0, 1, 0) |
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