Status:
TERMINATED
Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Lead Sponsor:
Pfizer
Collaborating Sponsors:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
52-87 years
Phase:
PHASE2
Brief Summary
The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in t...
Eligibility Criteria
Inclusion
- Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.
- Screening brain MRI scan is consistent with the diagnosis of AD.
- MMSE score 10 and above.
Exclusion
- Significant neurological diseases other than AD.
- Brain MRI evidence of vasogenic edema during the preceding studies.
- Clinically significant illness.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01238991
Start Date
December 1 2010
End Date
December 1 2013
Last Update
December 22 2014
Active Locations (11)
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1
Meitetsu Hospital
Nagoya, Aichi-ken, Japan, 451-8511
2
Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, Japan, 309-1793
3
Shonan Atsugi Hospital
Atsugi, Kanagawa, Japan, 243-8551
4
Kitasato University East Hospital
Sagamihara-shi, Kanagawa, Japan, 252-0380