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

Alzheimer's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02551809
• Other study ID #: V203-AD
• Status: Completed
• Phase: Phase 2
• Start date: October 2015
• Est. completion date: August 2018

Study information

• Verified date: March 2020
• Source: United Neuroscience Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• UB-311
Intramuscular injection

Drug:
• Placebo
Intramuscular injection

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital (KS-CGMH)	Kaohsiung
Taiwan	National Taiwan University Hospital (NTUH)	Taipei
Taiwan	Taipei Veterans General Hospital (TVGH)	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital (LK-CGMH)	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
United Neuroscience Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events	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.	78 weeks

External Links

•   Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease.
•   UB-311, a novel UBITh® amyloid ß peptide vaccine for mild Alzheimer's disease.