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

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.

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