Title
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
Phase
Phase 2Lead Sponsor
United Neuroscience Ltd.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Alzheimer's DiseaseIntervention/Treatment
ub-311 ...Study Participants
43The 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.
Intramuscular injection
Intramuscular injection
Subjects will receive 7 doses of UB-311.
Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
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
| Event Type | Organ System | Event Term | 3 Priming Doses Followed by 4 Boosters | 3 Priming Doses Followed by 2 Boosters | Placebo |
|---|
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.
