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

Alzheimer's Disease Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03531710
• Other study ID #: V203-AD-EXT
• Status: Terminated
• Phase: Phase 2
• Start date: August 10, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: January 2021
• Source: United Neuroscience Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• UB-311
Intramuscular injection

Drug:
• Placebo
Intramuscular injection

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
United Neuroscience Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	Change From Baseline and Through to the End of the Study in Anti-Aß Antibody Titers [The Immunogenicity of UB-311]	For the immunogenicity assessment of the investigational product, UB-311, the level of anti-Aß antibodies in the serum samples will be measured by a validated enzyme immunoassay manufactured by United Biomedical, Inc. (UBI). The level of anti-Aß antibodies is assessed at every visit throughout the study period.	Overall Study Duration/Early Termination, over an average study duration of 326 days

External Links

•   Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease.
•   UB-311, a novel UBITh® amyloid ß peptide vaccine for mild Alzheimer's disease.