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

This study has been completed.

First Received on August 24, 2009. Last Updated on August 22, 2011 History of Changes

Sponsor:	United Biomedical
Collaborators:	Taipei Veterans General Hospital,Taiwan National Taiwan University Hospital
Information provided by (Responsible Party):	United Biomedical
ClinicalTrials.gov Identifier:	NCT00965588

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 I

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

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:

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.

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 February 09, 2012