Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01193608
First received: August 19, 2010
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: AAB-003 (PF-05236812)
Other: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Week 39 ] [ Designated as safety issue: Yes ]
    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").

  • MRI findings [ Time Frame: Week 39 ] [ Designated as safety issue: Yes ]
    Type, frequency and severity of MRI abnormal findings for each participant

  • Electroardiogram (ECG) [ Time Frame: Week 39 ] [ Designated as safety issue: Yes ]
    Type, frequency and severity of ECG abnormal findings for each participant

  • Standard Pharmacokinetic parameters for AAB-003 [ Time Frame: Week 39 ] [ Designated as safety issue: No ]
    Measure Pharmacokinetic parameters for AAB-003: CMax, CAvg, TMax,AUClast, AUCinf, CLss, V, t1/2 from serum concentration of study drug


Secondary Outcome Measures:
  • The presence of anti-product antibodies to AAB-003 will be determined in serum [ Time Frame: Week 39 ] [ Designated as safety issue: Yes ]
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) [ Time Frame: Week 39 ] [ Designated as safety issue: No ]
  • Disability Assessment in Dementia (DAD) [ Time Frame: Week 39 ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: Week 39 ] [ Designated as safety issue: No ]
  • Clinical Dementia Rating Sum of Boxes (CDR-SB) [ Time Frame: Week 39 ] [ Designated as safety issue: No ]
  • Mini Mental State Exam (MMSE) [ Time Frame: Week 39 ] [ Designated as safety issue: No ]
  • CSF concentration of AAB-003 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
  • CSF amyloid-beta, tau, p-tau concentrations [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
  • Plasma amyloid-beta x-40 parameters (eg, Cmax, Tmax, AUClast, AUCinf, AUCtau, T1/2 [ Time Frame: Week 39 ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: September 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.5 mg/kg AAB-003 Drug: AAB-003 (PF-05236812)
0.5 mg/kg AAB-003, IV
Experimental: 1 mg/kg AAB-003 Drug: AAB-003 (PF-05236812)
1 mg/kg AAB-003, IV
Experimental: 2 mg/kg AAB-003 Drug: AAB-003 (PF-05236812)
2 mg/kg AAB-003, IV
Experimental: 4 mg/kg AAB-003 Drug: AAB-003 (PF-05236812)
4 mg/kg AAB-003, IV
Experimental: 8 mg/kg AAB-003 Drug: AAB-003 (PF-05236812)
8 mg/kg AAB-003, IV
Placebo Comparator: Placebo Other: Placebo
Placebo, IV

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193608

Locations
United States, California
Pfizer Investigational Site
Escondido, California, United States, 92025
United States, Florida
Pfizer Investigational Site
Hallandale Beach, Florida, United States, 33009
Pfizer Investigational Site
Ocala, Florida, United States, 34471
Pfizer Investigational Site
Ocala, Florida, United States, 34481
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30308
United States, Maryland
Pfizer Investigational Site
Bethesda, Maryland, United States, 20814
Pfizer Investigational Site
Rockville, Maryland, United States, 20850
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49048
United States, Mississippi
Pfizer Investigational Site
Flowood, Mississippi, United States, 39232
United States, Missouri
Pfizer Investigational Site
Creve Coeur, Missouri, United States, 63141
Pfizer Investigational Site
St. Louis, Missouri, United States, 63044
United States, New Jersey
Pfizer Investigational Site
Eatontown, New Jersey, United States, 07724
Pfizer Investigational Site
Edison, New Jersey, United States, 08837
Pfizer Investigational Site
Oakhurst, New Jersey, United States, 07755
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19131-1689
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19141
Korea, Republic of
Pfizer Investigational Site
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Pfizer Investigational Site
Incheon, Korea, Republic of, 400-711
Pfizer Investigational Site
Seoul, Korea, Republic of, 143-914
Pfizer Investigational Site
Seoul, Korea, Republic of, 136-705
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01193608     History of Changes
Other Study ID Numbers: B2601001
Study First Received: August 19, 2010
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Randomized
Safety Study
Adaptive
Double Blind

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014