An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311

• Status: Terminated
• Trial end date: 2019-10-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the long-term safety, tolerability and potential efficacy, patients who previously participated in V203-AD study (NCT02551809) will be eligible to participate in the extension study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period followed by a 12-week follow-up period.

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

Details

• Lead Sponsor: United Neuroscience Ltd.

Criteria

Inclusion Criteria:

• Patients who participated in V203-AD trial without major safety concerns;

• Stable doses of permitted medications for 3 months before screening;

• With a caregiver;

• 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