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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
UB-311
Placebo
Sponsored by
United Neuroscience Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital (KS-CGMH)
  • National Taiwan University Hospital (NTUH)
  • Taipei Veterans General Hospital (TVGH)
  • Linkou Chang Gung Memorial Hospital (LK-CGMH)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

3 priming doses followed by 4 boosters

3 priming doses followed by 2 boosters

Placebo

Arm Description

Subjects will receive 7 doses of UB-311.

Subjects will receive 5 doses of UB-311 and 2 doses of placebo.

Subjects will receive 7 doses of placebo.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2015
Last Updated
March 4, 2020
Sponsor
United Neuroscience Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02551809
Brief Title
Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Neuroscience Ltd.

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 priming doses followed by 4 boosters
Arm Type
Experimental
Arm Description
Subjects will receive 7 doses of UB-311.
Arm Title
3 priming doses followed by 2 boosters
Arm Type
Experimental
Arm Description
Subjects will receive 5 doses of UB-311 and 2 doses of placebo.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive 7 doses of placebo.
Intervention Type
Biological
Intervention Name(s)
UB-311
Intervention Description
Intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events
Description
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.
Time Frame
78 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital (KS-CGMH)
City
Kaohsiung
Country
Taiwan
Facility Name
National Taiwan University Hospital (NTUH)
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital (TVGH)
City
Taipei
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital (LK-CGMH)
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29067332
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/17287052?dopt=Abstract
Description
Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease.

Learn more about this trial

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

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