Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease
NCT00965588 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2011-08-23
Summary
The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients diagnosed with mild or moderate Alzheimer's disease (AD). Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD.
Conditions
Interventions
- BIOLOGICAL
-
UB 311
Single liquid dose by intramuscular route at weeks 0, 4, 12.
Sponsors & Collaborators
-
Taipei Veterans General Hospital, Taiwan
collaborator OTHER_GOV -
National Taiwan University Hospital
collaborator OTHER -
United Biomedical
lead INDUSTRY
Principal Investigators
-
Ming-Jang Chiu, M.D. · National Taiwan University Hospital
-
Pei-Ning Wang, M.D. · Taipei Veterans General Hospital, Taiwan
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-02-28
- Primary Completion
- 2011-04-30
- Completion
- 2011-04-30
Countries
- Taiwan
Study Locations
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