At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 43 enrolled
Drug / intervention
UB-311 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, 3-arm Parallel-group, Multicenter, Phase IIa Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311) in Patients With Mild Alzheimer's Disease
In Brief
A Phase 2 clinical trial evaluating UB-311 and Placebo for Alzheimer's Disease. Completed, enrolled 43 participants across 4 sites.
Detailed Summary
The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the secondary endpoint.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesTaiwan
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartOct 2015
Primary CompletionAug 2018
TodayJul 2026
First PostedSep 16, 2015
Enrollment StartOct 1, 2015
Primary CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.8 years ago
Interventions
UB-311biological
Intramuscular injection
Placebodrug
Intramuscular injection