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

Phase 2

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Biological: UB-311; Drug: Placebo

• Registration Number: NCT03531710
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-22
• Study Start: 2018-08-10
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Results First Submitted: 2020-09-24
• Results First Submitted QC: 2020-11-25
• Results First Posted: 2020-12-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3 boosters	UB-311	Subjects will receive 3 doses of UB-311 and 2 doses of placebo.
3 boosters	Placebo	Subjects will receive 3 doses of UB-311 and 2 doses of placebo.
3 priming doses followed by 2 boosters	UB-311	Subjects will receive 5 doses of UB-311.

Primary Outcome Measures

Name	Time	Method
Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]	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.
The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]).	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.

Trial Locations

Locations (4)

National Taiwan University Hospital (NTUH); 🇨🇳 Taipei, Taiwan

Linkou Chang Gung Memorial Hospital (LK-CGMH); 🇨🇳 Taoyuan, Taiwan

Kaohsiung Chang Gung Memorial Hospital (KS-CGMH); 🇨🇳 Kaohsiung, Taiwan

Taipei Veterans General Hospital (TVGH); 🇨🇳 Taipei, Taiwan