Trial record 5 of 34 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:
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

August 24, 2009
August 22, 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 ] [ Designated as safety issue: Yes ]
To evaluate safety and tolerability of the vaccine (UB-311). [ Time Frame: Screen, treatment & follow-up: 28-30 weeks ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
To evaluate immunogenicity [and efficacy] of the vaccine (UB-311). [ Time Frame: Screen, treatment & follow-up: 28-30 weeks ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00965588
UBI Protocol V118, Protocol V118-AD
Yes
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