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

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Biological: UB 311

• Registration Number: NCT00965588
• Lead Sponsor: United Biomedical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-22
• Last Update Posted: 2011-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccine (UB 311)	UB 311	-

Primary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability of the vaccine (UB 311).	Screen, treatment & follow-up: 28-30 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate immunogenicity [and efficacy] of the vaccine (UB 311).	Screen, treatment & follow-up: 28-30 weeks

Trial Locations

Locations (2)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

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