Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease

United Biomedical19 enrolled

Overview

The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients diagnosed with mild or moderate Alzheimer's disease (AD). Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer's Disease

Interventions

UB 311BIOLOGICAL

Single liquid dose by intramuscular route at weeks 0, 4, 12.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of mild to moderate Alzheimer's Disease * Mini-Mental State Examination (MMSE) 15-25 * Other inclusion criteria apply Exclusion Criteria: * Major psychiatric disorder * Severe systemic disease * Serious adverse reactions to any vaccine * Other exclusion criteria apply

Locations (2)

National Taiwan University Hospital (NTUH)

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

To evaluate safety and tolerability of the vaccine (UB 311).

Time frame: Screen, treatment & follow-up: 28-30 weeks

Secondary Outcomes

To evaluate immunogenicity [and efficacy] of the vaccine (UB 311).

Time frame: Screen, treatment & follow-up: 28-30 weeks

Data from ClinicalTrials.gov

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