Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease

United Biomedical

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Biological: UB 311

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00965588

Protocol V118-AD

UBI Protocol V118

Details and patient eligibility

About

The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients diagnosed with mild or moderate Alzheimer's disease (AD). Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD.

Enrollment: 19 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of mild to moderate Alzheimer's Disease
• Mini-Mental State Examination (MMSE) 15-25
• Other inclusion criteria apply

Exclusion criteria

• Major psychiatric disorder
• Severe systemic disease
• Serious adverse reactions to any vaccine
• Other exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Vaccine (UB 311)

Experimental group

Treatment:

Biological: UB 311