An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311

• ClinicalTrials.gov Identifier: NCT03531710
• Recruitment Status: Terminated
• First Posted: May 22, 2018
• Results First Posted: December 17, 2020
• Last Update Posted: January 26, 2021
• Sponsor: United Neuroscience Ltd.
• Information provided by (Responsible Party): United Neuroscience Ltd.

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

Additional Information:

Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. 

UB-311, a novel UBITh® amyloid β peptide vaccine for mild Alzheimer's disease. 

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

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

Additional relevant MeSH terms:

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