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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- United Neuroscience Ltd.
- Enrollment
- 34
- Locations
- 4
- Primary Endpoint
- Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
3 boosters
Subjects will receive 3 doses of UB-311 and 2 doses of placebo.
Intervention: UB-311 (Biological)
3 boosters
Subjects will receive 3 doses of UB-311 and 2 doses of placebo.
Intervention: Placebo (Drug)
3 priming doses followed by 2 boosters
Subjects will receive 5 doses of UB-311.
Intervention: UB-311 (Biological)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
No secondary outcomes reported