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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-10

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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3 boosters

Subjects will receive 3 doses of UB-311 and 2 doses of placebo.

Group Type EXPERIMENTAL

UB-311

Intervention Type BIOLOGICAL

Intramuscular injection

Placebo

Intervention Type DRUG

Intramuscular injection

3 priming doses followed by 2 boosters

Subjects will receive 5 doses of UB-311.

Group Type EXPERIMENTAL

UB-311

Intervention Type BIOLOGICAL

Intramuscular injection

Interventions

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UB-311

Intramuscular injection

Intervention Type BIOLOGICAL

Placebo

Intramuscular injection

Intervention Type DRUG

Eligibility Criteria

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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;

Exclusion Criteria

* Clinically significant neurological disease other than Alzheimer's disease
* Major psychiatric disorder
* Severe systemic disease
* Serious adverse reactions to any vaccine

Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No