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
Overview
- Phase
- Phase 2
- Intervention
- UB-311
- Conditions
- Alzheimer's Disease
- Sponsor
- United Neuroscience Ltd.
- Enrollment
- 43
- Locations
- 4
- Primary Endpoint
- Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
3 priming doses followed by 4 boosters
Subjects will receive 7 doses of UB-311.
Intervention: UB-311
3 priming doses followed by 2 boosters
Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
Intervention: UB-311
3 priming doses followed by 2 boosters
Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
Intervention: Placebo
Placebo
Subjects will receive 7 doses of placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events
Time Frame: 78 weeks
Safety endpoints include local tolerability at the injection site, amyloid-related imaging abnormalities, vital signs, physical examination, 12-lead ECG, laboratory tests and other AEs and SAEs.