Trial record 6 of 21 for:    alzheimer vaccine

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

This study has been completed.
Sponsor:
Collaborators:
Taipei Veterans General Hospital, Taiwan
National Taiwan University Hospital
Information provided by:
United Biomedical
ClinicalTrials.gov Identifier:
NCT01189084
First received: August 24, 2010
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

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 Intervention
Alzheimer's Disease
Biological: Observational

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by United Biomedical:

Primary Outcome Measures:
  • Immunogenicity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Long-term followup to week 48


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 14
Study Start Date: April 2010
Study Completion Date: July 2011
Groups/Cohorts Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189084

Locations
Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
National Taiwan University Hospital (NTUH)
Taipei, Taiwan, 10002
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)
  More Information

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
Study First Received: August 24, 2010
Last Updated: July 12, 2011
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 08, 2014