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

This study has been completed.
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer Identifier:
First received: August 19, 2010
Last updated: November 19, 2013
Last verified: November 2013
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
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 ]
    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 ]
    Type, frequency and severity of MRI abnormal findings for each participant

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

  • Standard Pharmacokinetic parameters for AAB-003 [ Time Frame: Week 39 ]
    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 ]
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) [ Time Frame: Week 39 ]
  • Disability Assessment in Dementia (DAD) [ Time Frame: Week 39 ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: Week 39 ]
  • Clinical Dementia Rating Sum of Boxes (CDR-SB) [ Time Frame: Week 39 ]
  • Mini Mental State Exam (MMSE) [ Time Frame: Week 39 ]
  • CSF concentration of AAB-003 [ Time Frame: Week 32 ]
  • CSF amyloid-beta, tau, p-tau concentrations [ Time Frame: Week 32 ]
  • Plasma amyloid-beta x-40 parameters (eg, Cmax, Tmax, AUClast, AUCinf, AUCtau, T1/2 [ Time Frame: Week 39 ]

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


Ages Eligible for Study:   50 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01193608

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, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 136-705
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 143-914
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT01193608     History of Changes
Other Study ID Numbers: B2601001 
Study First Received: August 19, 2010
Last Updated: November 19, 2013

Keywords provided by Pfizer:
Safety Study
Double Blind

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on February 20, 2017