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

United Neuroscience

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Biological: UB-311; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02551809

V203-AD

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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43 participants in 3 patient groups, including a placebo group

3 priming doses followed by 4 boosters

Experimental group

Description:

Subjects will receive 7 doses of UB-311.

Treatment:

Biological: UB-311

3 priming doses followed by 2 boosters

Experimental group

Description:

Subjects will receive 5 doses of UB-311 and 2 doses of placebo.

Treatment:

Drug: Placebo

Biological: UB-311

Placebo

Placebo Comparator group

Description:

Subjects will receive 7 doses of placebo.

Treatment:

Drug: Placebo