Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United Neuroscience Ltd.

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