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

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.

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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 Tauopathies

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kaohsiung Chang Gung Memorial Hospital (KS-CGMH), Kaohsiung City, Taiwan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

UB-311

Biological

Intramuscular injection

Placebo

Drug

Intramuscular injection

Primary outcomes

Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events

Time frame: 78 weeks

Safety endpoints include local tolerability at the injection site, amyloid-related imaging abnormalities, vital signs, physical examination, 12-lead ECG, laboratory tests and other AEs and SAEs.

Sponsors and collaborators

Lead sponsor

United Neuroscience Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, 3-arm Parallel-group, Multicenter, Phase IIa Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311) in Patients With Mild Alzheimer's Disease

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Sep 16, 2015
Registry last updated: Mar 17, 2020

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.

Completed