Observational Study to Monitor Long-term Immunogenicity and Efficacy of UB 311 Vaccine in Subjects With Alzheimer's Disease
Completed
- Conditions
- Alzheimer's Disease
- Interventions
- Biological: Observational
- Registration Number
- NCT01189084
- Lead Sponsor
- United Biomedical
- Brief Summary
The purpose of this observational study is to determine whether the vaccine (UB 311), targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's disease (AD) who previously received UB 311-treatment. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Individuals with mild to moderate Alzheimer's disease who received three (3) injections of UB 311 in the initial Phase I V118-AD trial
Exclusion Criteria
- Individuals with Alzheimer's disease who are currently on prohibited medications, have severe or uncontrolled systemic disease, or are unable or unwilling to comply with study protocol requirements.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational immunotherapy follow-up Observational -
- Primary Outcome Measures
Name Time Method Immunogenicity 24 weeks Long-term followup to week 48
- Secondary Outcome Measures
Name Time Method Efficacy 24 weeks Long-term followup to week 48
Trial Locations
- Locations (2)
National Taiwan University Hospital (NTUH)
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan