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Trial record 5 of 37 for:    alzheimer vaccine

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00965588
First Posted: August 25, 2009
Last Update Posted: August 23, 2011
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.
Collaborators:
Taipei Veterans General Hospital, Taiwan
National Taiwan University Hospital
Information provided by (Responsible Party):
United Biomedical
August 24, 2009
August 25, 2009
August 23, 2011
February 2009
April 2011   (Final data collection date for primary outcome measure)
To evaluate safety and tolerability of the vaccine (UB 311). [ Time Frame: Screen, treatment & follow-up: 28-30 weeks ]
Same as current
Complete list of historical versions of study NCT00965588 on ClinicalTrials.gov Archive Site
To evaluate immunogenicity [and efficacy] of the vaccine (UB 311). [ Time Frame: Screen, treatment & follow-up: 28-30 weeks ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease
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
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alzheimer's Disease
Biological: UB 311
Single liquid dose by intramuscular route at weeks 0, 4, 12.
Other Name: N.A.
Experimental: Vaccine (UB 311)
Intervention: Biological: UB 311
Wang CY, Finstad CL, Walfield AM, Sia C, Sokoll KK, Chang TY, Fang XD, Hung CH, Hutter-Paier B, Windisch M. Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. Vaccine. 2007 Apr 20;25(16):3041-52. Epub 2007 Jan 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
April 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00965588
UBI Protocol V118
Protocol V118-AD
Yes
Not Provided
Not Provided
United Biomedical
United Biomedical
  • Taipei Veterans General Hospital, Taiwan
  • National Taiwan University Hospital
Principal Investigator: Ming-Jang Chiu, M.D. National Taiwan University Hospital
Principal Investigator: Pei-Ning Wang, M.D. Taipei Veterans General Hospital, Taiwan
United Biomedical
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP