Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of the UBITh AD Immunotherapeutic Vaccine (UB 311) in Patients With Mild to Moderate Alzheimer's Disease|
- To evaluate safety and tolerability of the vaccine (UB 311). [ Time Frame: Screen, treatment & follow-up: 28-30 weeks ] [ Designated as safety issue: Yes ]
- To evaluate immunogenicity [and efficacy] of the vaccine (UB 311). [ Time Frame: Screen, treatment & follow-up: 28-30 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
|Experimental: Vaccine (UB 311)||
Biological: UB 311
Single liquid dose by intramuscular route at weeks 0, 4, 12.
Other Name: N.A.
|National Taiwan University Hospital (NTUH)|
|Taipei, Taiwan, 10002|
|Taipei Veterans General Hospital|
|Taipei, Taiwan, 11217|
|Principal Investigator:||Ming-Jang Chiu, M.D.||National Taiwan University Hospital|
|Principal Investigator:||Pei-Ning Wang, M.D.||Taipei Veterans General Hospital, Taiwan|