Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
NCT00479557 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2016-01-01
Summary
To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.
Conditions
- Alzheimer Disease
Interventions
- BIOLOGICAL
-
ACC-001 + QS-21
Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
- BIOLOGICAL
-
ACC-001
Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12
- BIOLOGICAL
-
QS-21
QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12
- DRUG
-
Placebo: Phosphate buffered saline
Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12
Sponsors & Collaborators
-
Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC
collaborator UNKNOWN - lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-05-31
- Primary Completion
- 2013-01-31
- Completion
- 2013-01-31
Countries
- France
- Germany
- Spain
Study Locations
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