Back to resultsAn Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
UB-311
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Patients who participated in V203-AD trial without major safety concerns;
- Stable doses of permitted medications for 3 months before screening;
- With a caregiver;
- 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 Type
Experimental
Experimental
Arm Label
3 boosters
3 priming doses followed by 2 boosters
Arm Description
Subjects will receive 3 doses of UB-311 and 2 doses of placebo.
Subjects will receive 5 doses of UB-311.
Outcomes
Primary Outcome Measures
The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]).
Summary of Treatment Emergent Adverse Events (TEAEs), based on reported adverse events and other safety information including local tolerability at injection site, MRI, vital signs, physical examination, 12-lead ECG and laboratory tests.
Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]
For the immunogenicity assessment of the investigational product, UB-311, the level of anti-Aβ antibodies in the serum samples will be measured by a validated enzyme immunoassay manufactured by United Biomedical, Inc. (UBI). The level of anti-Aβ antibodies is assessed at every visit throughout the study period.
Secondary Outcome Measures
Full Information
NCT ID
NCT03531710
First Posted
April 6, 2018
Last Updated
January 7, 2021
Sponsor
United Neuroscience Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03531710
Brief Title
An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311
Official Title
An Extension Study of a Phase IIa Study in Patients With Mild Alzheimer's Disease to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
United Neuroscience has decided to terminate V203-AD-EXT study based on a treatment assignment error
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (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
To evaluate the long-term safety, tolerability and potential efficacy, patients who previously participated in V203-AD study (NCT02551809) will be eligible to participate in the extension study and will receive 3 or 5 doses of UB-311 within a 96-week treatment period followed by a 12-week follow-up period.
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 ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3 boosters
Arm Type
Experimental
Arm Description
Subjects will receive 3 doses of UB-311 and 2 doses of placebo.
Arm Title
3 priming doses followed by 2 boosters
Arm Type
Experimental
Arm Description
Subjects will receive 5 doses of UB-311.
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
The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]).
Description
Summary of Treatment Emergent Adverse Events (TEAEs), based on reported adverse events and other safety information including local tolerability at injection site, MRI, vital signs, physical examination, 12-lead ECG and laboratory tests.
Time Frame
Overall Study Duration/Early Termination, over an average study duration of 326 days
Title
Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]
Description
For the immunogenicity assessment of the investigational product, UB-311, the level of anti-Aβ antibodies in the serum samples will be measured by a validated enzyme immunoassay manufactured by United Biomedical, Inc. (UBI). The level of anti-Aβ antibodies is assessed at every visit throughout the study period.
Time Frame
Overall Study Duration/Early Termination, over an average study duration of 326 days
Other Pre-specified Outcome Measures:
Title
Change From Baseline and Through to the End of the Study in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog);
Description
The ADAS-Cog 13 contains 13 items, with a total scoring range of 0 - 85 and higher scores indicating greater dysfunction. ADAS-Cog scores were evaluated at V1 and V8/ET. The observed values and change from baseline for ADAS-Cog scores by treatment groups in the extension study are presented
Time Frame
Overall Study Duration/Early Termination, over an average study duration of 326 days
Title
Change From Baseline and Through to the End of the Study in Mini-Mental State Exam (MMSE)
Description
The MMSE is a 30-point questionnaire. The total score range is 0 - 30 and lower scores indicating greater impairment. MMSE scores were evaluated at V1 and V8/ET. The observed values and change from baseline for MMSE scores by treatment groups in the extension study are presented
Time Frame
Overall Study Duration/Early Termination, over an average study duration of 326 days
Title
Change From Baseline and Through to the End of the Study in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Description
The CDR-SB includes 6 domains (0 - 3 points/domain), with a total scoring range of 0 - 18 and higher scores indicate greater impartment. CDR-SB scores were evaluated at V1 and V8/ET. The observed values and change from baseline for CDR-SB scores by treatment groups in the extension study are presented
Time Frame
Overall Study Duration/Early Termination, over an average study duration of 326 days
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:
Patients who participated in V203-AD trial without major safety concerns;
Stable doses of permitted medications for 3 months before screening;
With a caregiver;
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
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.
URL
http://www.ncbi.nlm.nih.gov/pubmed/?term=UB-311
Description
UB-311, a novel UBITh® amyloid β peptide vaccine for mild Alzheimer's disease.
Learn more about this trial
An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311
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