Study Stopped
United Neuroscience has decided to terminate V203-AD-EXT study based on a treatment assignment error
An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311
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)
1 other identifier
interventional
34
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2018
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2018
CompletedFirst Posted
Study publicly available on registry
May 22, 2018
CompletedStudy Start
First participant enrolled
August 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedResults Posted
Study results publicly available
December 17, 2020
CompletedJanuary 26, 2021
January 1, 2021
1.2 years
April 6, 2018
September 24, 2020
January 7, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Overall Study Duration/Early Termination, over an average study duration of 326 days
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.
Overall Study Duration/Early Termination, over an average study duration of 326 days
Other Outcomes (3)
Change From Baseline and Through to the End of the Study in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog);
Overall Study Duration/Early Termination, over an average study duration of 326 days
Change From Baseline and Through to the End of the Study in Mini-Mental State Exam (MMSE)
Overall Study Duration/Early Termination, over an average study duration of 326 days
Change From Baseline and Through to the End of the Study in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Overall Study Duration/Early Termination, over an average study duration of 326 days
Study Arms (2)
3 boosters
EXPERIMENTALSubjects will receive 3 doses of UB-311 and 2 doses of placebo.
3 priming doses followed by 2 boosters
EXPERIMENTALSubjects will receive 5 doses of UB-311.
Interventions
Eligibility Criteria
You may qualify if:
- Patients who participated in V203-AD trial without major safety concerns;
- Stable doses of permitted medications for 3 months before screening;
- With a caregiver;
You may not qualify if:
- Clinically significant neurological disease other than Alzheimer's disease
- Major psychiatric disorder
- Severe systemic disease
- Serious adverse reactions to any vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Kaohsiung Chang Gung Memorial Hospital (KS-CGMH)
Kaohsiung City, Taiwan
National Taiwan University Hospital (NTUH)
Taipei, Taiwan
Taipei Veterans General Hospital (TVGH)
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital (LK-CGMH)
Taoyuan District, Taiwan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1\. Due to the incorrect treatment assignment and study early termination, this study was underpowered for analysis with secondary endpoints. Therefore, all secondary endpoints (change in ADAS-Cog, MMSE, CDR-SB) were considered as exploratory efficacy endpoints. 2. qEEG, cortical thickness, computerized cognitive tests, and the change of amyloid deposition with substantial amount of missing data/visit so they were omitted from group comparison analysis.
Results Point of Contact
- Title
- Medical Director
- Organization
- United Neuroscience
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2018
First Posted
May 22, 2018
Study Start
August 10, 2018
Primary Completion
October 31, 2019
Study Completion
October 31, 2019
Last Updated
January 26, 2021
Results First Posted
December 17, 2020
Record last verified: 2021-01