Alzheimer's Disease Clinical Trial
Official title:
A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive, Multiple Ascending Dose Study Of The Safety, Tolerability And Pharmacokinetics Of AAB-003 (PF-05236812) In Subjects With Mild To Moderate Alzheimer's Disease
Verified date | November 2013 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812) or placebo. Each patient's participation will last approximately 41 weeks.
Status | Completed |
Enrollment | 88 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 89 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI consistent with the diagnosis of Alzheimer's Disease - Concurrent use of cholinesterase inhibitor or memantine allowed, if stable. - Caregiver will participate and be able to attend clinic visits with patient Exclusion Criteria: - Significant neurological disease other than Alzheimer's Disease - Major psychiatric disorder - Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body) - Women of childbearing potential |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Pfizer Investigational Site | Incheon | |
Korea, Republic of | Pfizer Investigational Site | Seongnam-si | Gyeonggi-do |
Korea, Republic of | Pfizer Investigational Site | Seoul | |
Korea, Republic of | Pfizer Investigational Site | Seoul | |
Korea, Republic of | Pfizer Investigational Site | Seoul | |
Korea, Republic of | Pfizer Investigational Site | Seoul | |
United States | Pfizer Investigational Site | Atlanta | Georgia |
United States | Pfizer Investigational Site | Bethesda | Maryland |
United States | Pfizer Investigational Site | Creve Coeur | Missouri |
United States | Pfizer Investigational Site | Eatontown | New Jersey |
United States | Pfizer Investigational Site | Edison | New Jersey |
United States | Pfizer Investigational Site | Escondido | California |
United States | Pfizer Investigational Site | Flowood | Mississippi |
United States | Pfizer Investigational Site | Hallandale Beach | Florida |
United States | Pfizer Investigational Site | Kalamazoo | Michigan |
United States | Pfizer Investigational Site | Oakhurst | New Jersey |
United States | Pfizer Investigational Site | Ocala | Florida |
United States | Pfizer Investigational Site | Ocala | Florida |
United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
United States | Pfizer Investigational Site | Rockville | Maryland |
United States | Pfizer Investigational Site | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Pfizer | JANSSEN Alzheimer Immunotherapy Research & Development, LLC |
United States, Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) | C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior"). | Week 39 | Yes |
Primary | MRI findings | Type, frequency and severity of MRI abnormal findings for each participant | Week 39 | Yes |
Primary | Electroardiogram (ECG) | Type, frequency and severity of ECG abnormal findings for each participant | Week 39 | Yes |
Primary | Standard Pharmacokinetic parameters for AAB-003 | Measure Pharmacokinetic parameters for AAB-003: CMax, CAvg, TMax,AUClast, AUCinf, CLss, V, t1/2 from serum concentration of study drug | Week 39 | No |
Secondary | The presence of anti-product antibodies to AAB-003 will be determined in serum | Week 39 | Yes | |
Secondary | Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) | Week 39 | No | |
Secondary | Disability Assessment in Dementia (DAD) | Week 39 | No | |
Secondary | Neuropsychiatric Inventory (NPI) | Week 39 | No | |
Secondary | Clinical Dementia Rating Sum of Boxes (CDR-SB) | Week 39 | No | |
Secondary | Mini Mental State Exam (MMSE) | Week 39 | No | |
Secondary | CSF concentration of AAB-003 | Week 32 | No | |
Secondary | CSF amyloid-beta, tau, p-tau concentrations | Week 32 | No | |
Secondary | Plasma amyloid-beta x-40 parameters (eg, Cmax, Tmax, AUClast, AUCinf, AUCtau, T1/2 | Week 39 | No |
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