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

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ClinicalTrials.gov Identifier: NCT02551809

Recruitment Status : Completed

First Posted : September 16, 2015

Results First Posted : January 13, 2020

Last Update Posted : March 17, 2020

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

United Neuroscience Ltd.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Biological: UB-311 Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	43 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
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
Actual Study Start Date :	October 2015
Actual Primary Completion Date :	August 2018
Actual Study Completion Date :	August 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Safety

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 3 priming doses followed by 4 boosters Subjects will receive 7 doses of UB-311.	Biological: UB-311 Intramuscular injection
Experimental: 3 priming doses followed by 2 boosters Subjects will receive 5 doses of UB-311 and 2 doses of placebo.	Biological: UB-311 Intramuscular injection Drug: Placebo Intramuscular injection
Placebo Comparator: Placebo Subjects will receive 7 doses of placebo.	Drug: Placebo Intramuscular injection

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	60 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551809

Locations

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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, Taiwan

Sponsors and Collaborators

United Neuroscience Ltd.

Study Documents (Full-Text)

Documents provided by United Neuroscience Ltd.:

Study Protocol [PDF] November 28, 2017

Statistical Analysis Plan [PDF] October 31, 2018

More Information

Additional Information:

Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wang CY, Wang PN, Chiu MJ, Finstad CL, Lin F, Lynn S, Tai YH, De Fang X, Zhao K, Hung CH, Tseng Y, Peng WJ, Wang J, Yu CC, Kuo BS, Frohna PA. UB-311, a novel UBITh(R) amyloid beta peptide vaccine for mild Alzheimer's disease. Alzheimers Dement (N Y). 2017 Apr 14;3(2):262-272. doi: 10.1016/j.trci.2017.03.005. eCollection 2017 Jun.

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Responsible Party:	United Neuroscience Ltd.
ClinicalTrials.gov Identifier:	NCT02551809
Other Study ID Numbers:	V203-AD
First Posted:	September 16, 2015 Key Record Dates
Results First Posted:	January 13, 2020
Last Update Posted:	March 17, 2020
Last Verified:	March 2020

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases	Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders

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