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

United Biomedical

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Biological: Observational

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01189084

UBI Protocol V118-obs

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

14 participants in 1 patient group

Observational immunotherapy follow-up

Treatment:

Biological: Observational