Observational Study to Monitor Long-term Immunogenicity and Efficacy of UB 311 Vaccine in Subjects With Alzheimer's Disease
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||An Observational Study to the Patients With Alzheimer's Disease Who Previously Received UB311-Treatment in the V118-AD Trial|
- Immunogenicity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Long-term followup to week 48
- Efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Long-term followup to week 48
Biospecimen Retention: Samples Without DNA
Periodic blood samples collected for serum and measurement of anti-Amyloid-beta antibody levels.
|Study Start Date:||April 2010|
|Study Completion Date:||July 2011|
|Observational immunotherapy follow-up||
Measure anti-Amyloid-beta antibody in serum during 24-26 weeks extension period to 48 weeks (after first vaccine treatment).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189084
|Taipei Veterans General Hospital|
|Taipei, Taiwan, 11217|
|National Taiwan University Hospital (NTUH)|
|Taipei, Taiwan, 10002|
|Principal Investigator:||Pei-Ning Wang, M.D.||Taipei Veterans General Hospital (TVGH)|
|Principal Investigator:||Ming-Jang Chiu, M.D.||National Taiwan University Hospital (NTUH)|