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

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ClinicalTrials.gov Identifier: NCT01189084
Recruitment Status : Completed
First Posted : August 26, 2010
Last Update Posted : July 13, 2011
Sponsor:
Collaborators:
Taipei Veterans General Hospital, Taiwan
National Taiwan University Hospital
Information provided by:
United Biomedical

Tracking Information
First Submitted Date August 24, 2010
First Posted Date August 26, 2010
Last Update Posted Date July 13, 2011
Study Start Date April 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: August 24, 2010)
Immunogenicity [ Time Frame: 24 weeks ]
Long-term followup to week 48
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 24, 2010)
Efficacy [ Time Frame: 24 weeks ]
Long-term followup to week 48
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study to Monitor Long-term Immunogenicity and Efficacy of UB 311 Vaccine in Subjects With Alzheimer's Disease
Official Title An Observational Study to the Patients With Alzheimer's Disease Who Previously Received UB311-Treatment in the V118-AD Trial
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Periodic blood samples collected for serum and measurement of anti-Amyloid-beta antibody levels.
Sampling Method Non-Probability Sample
Study Population Enrolled subjects who received UB 311-treatment in the initial UBI Protocol V118 (Protocol V118-AD) Phase I trial are eligible for continued follow-up to week 48
Condition 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).
Study Groups/Cohorts Observational immunotherapy follow-up
Intervention: Biological: Observational
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 12, 2011)
14
Original Estimated Enrollment
 (submitted: August 24, 2010)
18
Actual Study Completion Date July 2011
Primary Completion Date Not Provided
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01189084
Other Study ID Numbers UBI Protocol V118-obs
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pei-Ning Wang, M.D., Principal Investigator, Taipei Veterans General Hospital (TVGH)
Study Sponsor United Biomedical
Collaborators
  • Taipei Veterans General Hospital, Taiwan
  • National Taiwan University Hospital
Investigators
Principal Investigator: Pei-Ning Wang, M.D. Taipei Veterans General Hospital (TVGH)
Principal Investigator: Ming-Jang Chiu, M.D. National Taiwan University Hospital (NTUH)
PRS Account United Biomedical
Verification Date July 2011