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

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)

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Biological: UB-311
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3 boosters<br>Subjects will receive 3 doses of UB-311 and 2 doses of placebo. | Biological: UB-311<br>* Intramuscular injection<br>Drug: Placebo<br>* Intramuscular injection<br>|
| Experimental: 3 priming doses followed by 2 boosters<br>Subjects will receive 5 doses of UB-311. | Biological: UB-311<br>* Intramuscular injection<br>|

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 |