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)

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Biological: UB-311; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: United Neuroscience Ltd.

Publications and helpful links

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: V203-AD-EXT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No