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
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

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: 52 weeks ] [ 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").

  • Electrocardiogram (ECG) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Measure incidence, frequency and severity of ECG abnormal findings

  • MRI [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Measure incidence, frequency and severity of MRI abnormal findings


Secondary Outcome Measures:
  • The presence of anti-product antibodies to AAB-003 will be determined in serum [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Disability Assessment in Dementia (DAD) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Clinical Demential Rating Sum of Boxes (CDR-SB) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Mini Mental State Exam (MMSE) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • CSF abeta, tau, p-tau, AAB-003 concentrations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Plasma abeta concentrations and associated parameters (eg, Cmax, Tmax, AUClast, AUCinf, t1/2, as appropriate) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: July 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (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

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT01369225

Locations
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States, 33009
Renstar Medical Research
Ocala, Florida, United States, 34471
Munroe Regional Medical Center
Ocala, Florida, United States, 34471
Advanced Imaging of Ocala
Ocala, Florida, United States, 34481
Franck's Pharmacy
Ocala, Florida, United States, 34471
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Maryland
Foers Medical Arts Pharmacy
Bethesda, Maryland, United States, 20814
CBH Health, LLC
Rockville, Maryland, United States, 20850
United States, Michigan
KNI Southwest Michigan Imaging Center, LLC
Kalamazoo, Michigan, United States, 49048
Borgess Research Institute
Kalamazoo, Michigan, United States, 49048
Borgess Medical Center
Kalamazoo, Michigan, United States, 49048
United States, Missouri
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, United States, 63141
DePaul Health Center
St. Louis, Missouri, United States, 63044
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
Central Jersey Radiology
Oakhurst, New Jersey, United States, 07755
Korea, Republic of
Seoul National University Bundang Hospital, Department of Neurology
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Inha University Hospital, Department of Neurology
Incheon, Korea, Republic of, 400-711
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
ASAN Medical Center
Seoul, Korea, Republic of, 138-736
Samsung Medical Center, Department of Neurology
Seoul, Korea, Republic of, 135-710
Konkuk University Medical Center, Department of Neurology
Seoul, Korea, Republic of, 143-729
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: NCT01369225     History of Changes
Other Study ID Numbers: B2601003
Study First Received: May 10, 2011
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Randomized
Safety Study
Open Label

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

ClinicalTrials.gov processed this record on October 21, 2014