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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00965588
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : August 23, 2011
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
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
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vaccine (UB 311) Biological: UB 311
Single liquid dose by intramuscular route at weeks 0, 4, 12.
Other Name: N.A.


Outcome Measures

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
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

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