Phase 2
Completed N=43
Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients
Source: ClinicalTrials.gov NCT02551809 ↗Enrolled (actual)
43
Serious AEs
14.0%
Results posted
Jan 2020
Primary outcomePrimary: Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events — 10; 13; 13 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events |
10; 13; 13 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of mild Alzheimer's Disease
- Mini-Mental State Examination (MMSE) scores between 20 and 26 (inclusive)
- Clinical dementia rating (CDR) scores of 0.5 or 1
- Other inclusion criteria apply
Exclusion Criteria
- Clinically significant neurological disease other than Alzheimer's disease
- Major psychiatric disorder
- Severe systemic disease
- Serious adverse reactions to any vaccine
- Other exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02551809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.