Observational Study to Monitor Long-term Immunogenicity and Efficacy of UB 311 Vaccine in Subjects With Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

An Observational Study to the Patients With Alzheimer's Disease Who Previously Received UB311-Treatment in the V118-AD Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189084
• Other study ID #: UBI Protocol V118-obs
• Status: Completed
• Phase: N/A
• First received: August 24, 2010
• Last updated: July 12, 2011
• Start date: April 2010
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: United Biomedical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthTaiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this observational study is to determine whether the vaccine (UB 311), targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's disease (AD) who previously received UB 311-treatment. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Individuals with mild to moderate Alzheimer's disease who received three (3) injections of UB 311 in the initial Phase I V118-AD trial

Exclusion Criteria:

• Individuals with Alzheimer's disease who are currently on prohibited medications, have severe or uncontrolled systemic disease, or are unable or unwilling to comply with study protocol requirements.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• Observational
Measure anti-Amyloid-beta antibody in serum during 24-26 weeks extension period to 48 weeks (after first vaccine treatment).

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital (NTUH)	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
United Biomedical	National Taiwan University Hospital, Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Wang CY, Finstad CL, Walfield AM, Sia C, Sokoll KK, Chang TY, Fang XD, Hung CH, Hutter-Paier B, Windisch M. Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. Vaccine. 2007 Apr 20;25(16):3041-52. Epub 2007 Jan 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity	Long-term followup to week 48	24 weeks	No
Secondary	Efficacy	Long-term followup to week 48	24 weeks	No

External Links

•   ClinicalTrials.gov Identifier: NCT00965588