Observational Study to Monitor Long-term Immunogenicity and Efficacy of UB 311 Vaccine in Subjects With Alzheimer's Disease

United Biomedical14 enrolled

Overview

The purpose of this observational study is to determine whether the vaccine (UB 311), targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's disease (AD) who previously received UB 311-treatment. 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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Alzheimer's Disease

Interventions

ObservationalBIOLOGICAL

Measure anti-Amyloid-beta antibody in serum during 24-26 weeks extension period to 48 weeks (after first vaccine treatment).

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals with mild to moderate Alzheimer's disease who received three (3) injections of UB 311 in the initial Phase I V118-AD trial Exclusion Criteria: * Individuals with Alzheimer's disease who are currently on prohibited medications, have severe or uncontrolled systemic disease, or are unable or unwilling to comply with study protocol requirements.

Locations (2)

National Taiwan University Hospital (NTUH)

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Immunogenicity

Long-term followup to week 48

Time frame: 24 weeks

Secondary Outcomes

Efficacy

Long-term followup to week 48

Time frame: 24 weeks

Data from ClinicalTrials.gov

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