Status:
COMPLETED
Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 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 active immunization product+, in subjects with mild to moderate Alzheimer's...
Eligibility Criteria
Inclusion
- Subjects randomized under previous 3134K1-200 study (NCT00479557) 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 ≥10
Exclusion
- Significant Neurological Disease other than Alzheimer's disease
- Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
- Clinically significant systemic illness
Key Trial Info
Start Date :
November 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2013
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00955409
Start Date
November 5 2009
End Date
December 17 2013
Last Update
March 25 2021
Active Locations (17)
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1
CMRR Bordeaux CHU Pellegrin
Bordeaux, France, 33076
2
Hopital Roger Salengro
Lille, France, 59037
3
Hôpital Roger Salengro
Lille, France, 59037
4
CHU La Timone
Marseille, France, 13385