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Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate 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:
NCT01369225
First received: May 10, 2011
Last updated: September 26, 2014
Last verified: September 2014

May 10, 2011
September 26, 2014
July 2011
August 2014   (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: 52 weeks ]
    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").
  • Electrocardiogram (ECG) [ Time Frame: 52 weeks ]
    Measure incidence, frequency and severity of ECG abnormal findings
  • MRI [ Time Frame: 52 weeks ]
    Measure incidence, frequency and severity of MRI abnormal findings
Adverse events, clinical laboratory results, vital signs, physical and neurological examinations, ECGs, Columbia Suicide Severity Rating Scale (C-SSRS), magnetic resonance imaging (MRI) of the brain. [ Time Frame: 52 weeks ]
Complete list of historical versions of study NCT01369225 on ClinicalTrials.gov Archive Site
  • The presence of anti-product antibodies to AAB-003 will be determined in serum [ Time Frame: 52 weeks ]
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) [ Time Frame: 52 weeks ]
  • Disability Assessment in Dementia (DAD) [ Time Frame: 52 weeks ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 52 weeks ]
  • Clinical Demential Rating Sum of Boxes (CDR-SB) [ Time Frame: 52 weeks ]
  • Mini Mental State Exam (MMSE) [ Time Frame: 52 weeks ]
  • CSF abeta, tau, p-tau, AAB-003 concentrations [ Time Frame: 52 weeks ]
  • Plasma abeta concentrations and associated parameters (eg, Cmax, Tmax, AUClast, AUCinf, t1/2, as appropriate) [ Time Frame: 52 weeks ]
  • The presence of anti-product antibodies to AAB-003 will be determined in serum [ Time Frame: 52 weeks ]
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) [ Time Frame: 52 weeks ]
  • Disability Assessment in Dementia (DAD) [ Time Frame: 52 weeks ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 52 weeks ]
  • Clinical Demential Rating Sum of Boxes (CDR-SB) [ Time Frame: 52 weeks ]
  • Mini Mental State Exam (MMSE) [ Time Frame: 52 weeks ]
  • CSF abeta, tau, p-tau, AAB-003 concentrations [ Time Frame: 52 weeks ]
Not Provided
Not Provided
 
Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease
A Multicenter, Open-label Extension, Multiple Dose, Parallel Group Study To Investigate The Long-term Safety And Tolerability Of Aab-003 (Pf-05236812) Administered Intravenously In Subjects With Mild To Moderate Alzheimer's Disease Previously Treated With Aab-003 Or Placebo In Protocol B2601001
This is a study to evaluate the safety and tolerability of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each patient's participation will last approximately 52 weeks.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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
  • 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)
Delnomdedieu M, Duvvuri S, Li DJ, Atassi N, Lu M, Brashear HR, Liu E, Ness S, Kupiec JW. First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease. Alzheimers Res Ther. 2016 Mar 1;8(1):12. doi: 10.1186/s13195-016-0177-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Successful completion of study B2601001
  • MMSE 12 or greater

Exclusion Criteria:

  • Study B2601001 Week 32 MRI with clinically important exclusionary findings.
  • Experienced SAE, vasogenic edema and/or intracranial hemorrhage in study B2601001
Sexes Eligible for Study: All
50 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Korea, Republic of
 
 
NCT01369225
B2601003
No
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

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