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Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) 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 (Responsible Party):
United Biomedical
ClinicalTrials.gov Identifier:
NCT00965588
First received: August 24, 2009
Last updated: August 22, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Biological: UB 311
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of the UBITh AD Immunotherapeutic Vaccine (UB 311) in Patients With Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by United Biomedical:

Primary Outcome Measures:
  • To evaluate safety and tolerability of the vaccine (UB 311). [ Time Frame: Screen, treatment & follow-up: 28-30 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate immunogenicity [and efficacy] of the vaccine (UB 311). [ Time Frame: Screen, treatment & follow-up: 28-30 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: February 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine (UB 311) Biological: UB 311
Single liquid dose by intramuscular route at weeks 0, 4, 12.
Other Name: N.A.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965588

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: Ming-Jang Chiu, M.D. National Taiwan University Hospital
Principal Investigator: Pei-Ning Wang, M.D. Taipei Veterans General Hospital,Taiwan
  More Information

Publications:

Responsible Party: United Biomedical
ClinicalTrials.gov Identifier: NCT00965588     History of Changes
Other Study ID Numbers: UBI Protocol V118, Protocol V118-AD
Study First Received: August 24, 2009
Last Updated: August 22, 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 May 16, 2013