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Trial record 1 of 4 for:    UB-311
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An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531710
Recruitment Status : Terminated (United Neuroscience has decided to terminate V203-AD-EXT study based on a treatment assignment error)
First Posted : May 22, 2018
Results First Posted : December 17, 2020
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
United Neuroscience Ltd.

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 10, 2018
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3 boosters
Subjects will receive 3 doses of UB-311 and 2 doses of placebo.
Biological: UB-311
Intramuscular injection

Drug: Placebo
Intramuscular injection

Experimental: 3 priming doses followed by 2 boosters
Subjects will receive 5 doses of UB-311.
Biological: UB-311
Intramuscular injection




Primary Outcome Measures :
  1. The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]). [ Time Frame: Overall Study Duration/Early Termination, over an average study duration of 326 days ]
    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.

  2. Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311] [ Time Frame: Overall Study Duration/Early Termination, over an average study duration of 326 days ]
    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.


Other Outcome Measures:
  1. Change From Baseline and Through to the End of the Study in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog); [ Time Frame: Overall Study Duration/Early Termination, over an average study duration of 326 days ]
    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

  2. Change From Baseline and Through to the End of the Study in Mini-Mental State Exam (MMSE) [ Time Frame: Overall Study Duration/Early Termination, over an average study duration of 326 days ]
    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

  3. Change From Baseline and Through to the End of the Study in Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: Overall Study Duration/Early Termination, over an average study duration of 326 days ]
    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



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:

  • 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

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): NCT03531710


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] January 22, 2018
Statistical Analysis Plan  [PDF] February 10, 2020

Additional Information:
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Responsible Party: United Neuroscience Ltd.
ClinicalTrials.gov Identifier: NCT03531710    
Other Study ID Numbers: V203-AD-EXT
First Posted: May 22, 2018    Key Record Dates
Results First Posted: December 17, 2020
Last Update Posted: January 26, 2021
Last Verified: January 2021

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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