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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

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.

Condition or disease Intervention/treatment
Alzheimer's Disease Biological: Observational

Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to the Patients With Alzheimer's Disease Who Previously Received UB311-Treatment in the V118-AD Trial
Study Start Date : April 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observational immunotherapy follow-up Biological: Observational
Measure anti-Amyloid-beta antibody in serum during 24-26 weeks extension period to 48 weeks (after first vaccine treatment).




Primary Outcome Measures :
  1. Immunogenicity [ Time Frame: 24 weeks ]
    Long-term followup to week 48


Secondary Outcome Measures :
  1. Efficacy [ Time Frame: 24 weeks ]
    Long-term followup to week 48


Biospecimen Retention:   Samples Without DNA
Periodic blood samples collected for serum and measurement of anti-Amyloid-beta antibody levels.


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189084


Locations
Taiwan
National Taiwan University Hospital (NTUH)
Taipei, Taiwan, 10002
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
United Biomedical
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)

Additional Information:
Publications:
Responsible Party: Pei-Ning Wang, M.D., Principal Investigator, Taipei Veterans General Hospital (TVGH)
ClinicalTrials.gov Identifier: NCT01189084     History of Changes
Other Study ID Numbers: UBI Protocol V118-obs
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: July 13, 2011
Last Verified: July 2011

Keywords provided by United Biomedical:
Alzheimer's disease
amyloid beta
vaccine

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dementia
Tauopathies
Vaccines
Immunologic Factors
Physiological Effects of Drugs