Trials / Completed
CompletedNCT02551809
Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- United Neuroscience Ltd. · Industry
- Sex
- All
- Age
- 60 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | UB-311 | Intramuscular injection |
| DRUG | Placebo | Intramuscular injection |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
- First posted
- 2015-09-16
- Last updated
- 2020-03-17
- Results posted
- 2020-01-13
Locations
4 sites across 1 country: Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02551809. Inclusion in this directory is not an endorsement.