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Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00965588
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : August 23, 2011
Sponsor:
Collaborators:
Taipei Veterans General Hospital, Taiwan
National Taiwan University Hospital
Information provided by (Responsible Party):
United Biomedical

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Biological: UB 311 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vaccine (UB 311) Biological: UB 311
Single liquid dose by intramuscular route at weeks 0, 4, 12.


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

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

Eligibility Criteria
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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
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
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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): NCT00965588


Locations
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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
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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
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Publications:

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Responsible Party: United Biomedical
ClinicalTrials.gov Identifier: NCT00965588    
Other Study ID Numbers: UBI Protocol V118
Protocol V118-AD
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011
Keywords provided by United Biomedical:
Alzheimer's disease
amyloid beta
vaccine
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders