Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B2571009 | Other Identifier | Alias Study Number |
Not provided
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| Name | Class |
|---|---|
| JANSSEN Alzheimer Immunotherapy Research & Development, LLC | INDUSTRY |
Not provided
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The purpose of this study is to assess the safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in Japan.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACC-001 + QS-21 | Experimental | Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12 |
|
| QS-21 | Placebo Comparator | Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACC-001 | Biological | IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 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 radiologists. | 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 | Geotmetric 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, 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 study, 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 |
|---|---|---|---|---|---|---|
| Tazuke Kofukai Medical Research Institute Kitano Hospital | Osaka | Osaka | 530-8480 | Japan | ||
| Meitetsu 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 |
Not provided
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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 1, 3, 6 and 12 |
| FG001 | 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 1, 3, 6 and 12 |
| FG002 | 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 |
| FG003 | QS-21 | A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 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 1, 3, 6 and 12 |
| BG001 | ACC-001 10 Micrograms + QS-21 |
| 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 1, 3, 6 and 12 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | 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
Not provided
Not provided
| QS-21 | Other | IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12 |
|
| QS-21 | Other | IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 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, 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, 52 and 78. | 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), WMS-Verbal 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, 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 |
| 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 |
| The Jikei University School of medicine | Tokyo | 105-8471 | 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 |
| Investigator Request |
|
| Caregiver Request |
|
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 |
| BG002 | 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 |
| BG003 | QS-21 | A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 |
| BG004 | 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) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 |
| OG002 | 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 |
| OG003 | QS-21 | A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 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 radiologists. | 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 | Geotmetric 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, 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 study, 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, 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, 52 and 78. | 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), WMS-Verbal 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, 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 |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| EG001 | 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 1, 3, 6 and 12 | 0 | 9 | 8 | 9 |
| EG002 | 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 | 0 | 9 | 9 | 9 |
| EG003 | QS-21 | A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 | 0 | 8 | 7 | 8 |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Food allergy | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Positive Rombergism | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Lipid metabolism disorder | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cerebral microhaemorrhage | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhagic cerebral infarction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Intercostal neuralgia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Meralgia paraesthetica | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 15.1 | 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 |
|
| Mental Status |
|
| Speech |
|
| Cranial Nerves |
|
| Visual Field |
|
| Sensory |
|
| Motor |
|
| Coordination |
|
| Gate |
|
| Primitive reflexes |
|
| Tendon reflexes |
|
| Romberg |
|
| Week 2 (n=6,9,9,8) |
|
| Week 4 (n=6,9,9,8) |
|
| Week 6 (n=6,9,9,8) |
|
| Week 8 (n=6,9,9,8) |
|
| Week 10 (n=6,9,9,8) |
|
| Week 14 (n=6,9,9,8) |
|
| Week 16 (n=6,9,9,8) |
|
| Week 24 (n=6,9,9,8) |
|
| Week 28 (n=6,9,7,8) |
|
| Week 30 (n=6,9,7,8) |
|
| Week 40 (n=5,9,8,8) |
|
| Week 50 (n=6,8,7,8) |
|
| Week 54 (n=5,8,7,7) |
|
| Week 56 (n=4,8,7,7) |
|
| Week 66 (n=4,8,7,7) |
|
| Week 78 (n=4,8,6,7) |
|
| Week 91 (n=0,1,1,0) |
|
| Week 104 (n=0,1,1,0) |
|
| Week 2 (n=6,9,9,8) |
|
| Week 4 (n=6,9,9,8) |
|
| Week 6 (n=6,9,9,8) |
|
| Week 8 (n=6,9,9,8) |
|
| Week 10 (n=6,9,9,8) |
|
| Week 14 (n=6,9,9,8) |
|
| Week 16 (n=6,9,9,8) |
|
| Week 24 (n=6,9,9,8) |
|
| Week 28 (n=6,9,7,8) |
|
| Week 30 (n=6,9,7,8) |
|
| Week 40 (n=5,9,8,8) |
|
| Week 50 (n=6,8,7,8) |
|
| Week 54 (n=5,8,7,7) |
|
| Week 56 (n=4,8,7,7) |
|
| Week 66 (n=4,8,7,7) |
|
| Week 78 (n=4,8,6,7) |
|
| Week 91 (n=0,1,1,0) |
|
| Week 104 (n=0,1,1,0) |
|
| Week 26 (n=6,9,9,8) |
|
| Week 52 (n=5,9,7,8) |
|
| Week 78 (n=4,8,6,7) |
|
| Week 104 (n=0,1,1,0) |
|
| Week 26 (n=6,9,8,8) |
|
| Week 52 (n=5,8,6,8) |
|
| Week 78 (n=4,8,5,6) |
|
| Week 104 (n=0,1,1,0) |
|
| Week 26 (n=6,9,9,8) |
|
| Week 52 (n=5,9,7,8) |
|
| Week 78 (n=4,8,6,7) |
|
| Week 104 (n=0,1,1,0) |
|
| Week 8 (n=6,9,9,8) |
|
| Week 12 (n=6,9,9,8) |
|
| Week 16 (n=6,9,9,8) |
|
| Week 26 (n=6,9,8,8) |
|
| Week 30 (n=6,9,8,8) |
|
| Week 40 (n=4,9,7,8) |
|
| Week 52 (n=5,8,7,7) |
|
| Week 78 (n=4,8,6,7) |
|
| Week 104 (n=0,1,1,0) |
|