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

United Neuroscience

Status and phase: Terminated; Phase 2

Conditions: Alzheimer's Disease

Treatments: Biological: UB-311; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03531710

V203-AD-EXT

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups

3 boosters

Experimental group

Description:

Subjects will receive 3 doses of UB-311 and 2 doses of placebo.

Treatment:

Biological: UB-311

Drug: Placebo

3 priming doses followed by 2 boosters

Experimental group

Description:

Subjects will receive 5 doses of UB-311.

Treatment:

Biological: UB-311