Trials / Terminated
TerminatedNCT03531710
An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311
An Extension Study of a Phase IIa Study in Patients With Mild Alzheimer's Disease to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- United Neuroscience Ltd. · Industry
- Sex
- All
- Age
- 60 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the long-term safety, tolerability and potential efficacy, patients who previously participated in V203-AD study (NCT02551809) will be eligible to participate in the extension study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period followed by a 12-week follow-up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | UB-311 | Intramuscular injection |
| DRUG | Placebo | Intramuscular injection |
Timeline
- Start date
- 2018-08-10
- Primary completion
- 2019-10-31
- Completion
- 2019-10-31
- First posted
- 2018-05-22
- Last updated
- 2021-01-26
- Results posted
- 2020-12-17
Locations
4 sites across 1 country: Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03531710. Inclusion in this directory is not an endorsement.