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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

August 19, 2010
November 19, 2013
September 2010
October 2013   (final data collection date for primary outcome measure)
  • 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
  • Pharmacokinetic parameters for AAB-003. [ Time Frame: Week 39 ] [ Designated as safety issue: No ]
  • Adverse events, clinical laboratory results, vital signs, physical and neurological examinations, ECGs, Columbia Severity Rating Scale (C-SSRS), magnetic resonance imaging (MRI) of the brain. [ Time Frame: Week 39 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01193608 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: AAB-003 (PF-05236812)
    0.5 mg/kg AAB-003, IV
  • Drug: AAB-003 (PF-05236812)
    1 mg/kg AAB-003, IV
  • Drug: AAB-003 (PF-05236812)
    2 mg/kg AAB-003, IV
  • Drug: AAB-003 (PF-05236812)
    4 mg/kg AAB-003, IV
  • Drug: AAB-003 (PF-05236812)
    8 mg/kg AAB-003, IV
  • Other: Placebo
    Placebo, IV
  • Experimental: 0.5 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Experimental: 1 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Experimental: 2 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Experimental: 4 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Experimental: 8 mg/kg AAB-003
    Intervention: Drug: AAB-003 (PF-05236812)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Korea, Republic of
 
NCT01193608
B2601001
Yes
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP