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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01193608
Other study ID # B2601001
Secondary ID
Status Completed
Phase Phase 1
First received August 19, 2010
Last updated November 19, 2013
Start date September 2010
Est. completion date October 2013

Study information

Verified date November 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AAB-003 (PF-05236812)
0.5 mg/kg AAB-003, IV
AAB-003 (PF-05236812)
1 mg/kg AAB-003, IV
AAB-003 (PF-05236812)
2 mg/kg AAB-003, IV
AAB-003 (PF-05236812)
4 mg/kg AAB-003, IV
AAB-003 (PF-05236812)
8 mg/kg AAB-003, IV
Other:
Placebo
Placebo, IV

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Pfizer JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

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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