Status:
TERMINATED
A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Pfizer
Collaborating Sponsors:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease.
Eligibility Criteria
Inclusion
- Subjects randomized under previous 3134K1-2201 study (NCT00498602) and met all inclusion/and none of the exclusion criteria.
- Screening brain MRI scan is consistent with the diagnosis of AD.
- Mini-Mental State Examination (MMSE) score greater than or equal to 10.
- Other criteria apply.
Exclusion
- Significant Neurological Disease other than Alzheimer's disease.
- Current clinically significant systemic illness.
- Other exclusion criteria apply.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00960531
Start Date
July 1 2009
End Date
December 1 2013
Last Update
April 1 2016
Active Locations (28)
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1
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
2
Banner Boswell Medical Center
Sun City, Arizona, United States, 85351
3
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
4
University of California San Francisco
San Francisco, California, United States, 94117