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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Tauopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital (NTUH), Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational

Biological

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

Primary outcomes

Immunogenicity

Time frame: 24 weeks

Long-term followup to week 48

Secondary outcomes

Efficacy

Time frame: 24 weeks

Long-term followup to week 48

Sponsors and collaborators

Lead sponsor

United Biomedical

Industry

Collaborators

National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan

Registry information

Official study title

An Observational Study to the Patients With Alzheimer's Disease Who Previously Received UB311-Treatment in the V118-AD Trial

Important dates

Study start: 2010
Study completion: 2011
First posted: Aug 26, 2010
Registry last updated: Jul 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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