Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease, amyloid beta, vaccine
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.
Interventions
BIOLOGICALObservational
Measure anti-Amyloid-beta antibody in serum during 24-26 weeks extension period to 48 weeks (after first vaccine treatment).
Sponsors
Taipei Veterans General Hospital, Taiwan
National Taiwan University Hospital
United Biomedical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | 24 weeks | Long-term followup to week 48 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 24 weeks | Long-term followup to week 48 |
Countries
Taiwan
Outcome results
None listed