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

This study is currently recruiting participants.

Verified by United Biomedical, August 2009

First Received: August 24, 2009 Last Updated: August 25, 2009 History of Changes

Sponsor:	United Biomedical
Collaborator:	UBI Asia
Information provided by:	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:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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 ]

Estimated Enrollment:	18
Study Start Date:	February 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vaccine (UB 311): Experimental	Biological: UB 311 Single liquid dose by intramuscular route at weeks 0, 4, 12.

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

Contacts

Contact: Yi-Ting Tseng

011-886-3-598-5737 ext 613

yiting@ubiasia.com.tw

Locations

Taiwan
National Taiwan University Hosptial (NTUH)	Recruiting
Taipei, Taiwan
Contact: Ming-Jang Chiu, M.D. 011-886-2-2312-3456 ext 65339 mjchiu@ntu.edu.tw
Principal Investigator: Ming-Jang Chiu, M.D.
Taipei Veterans General Hospital (TVGH)	Recruiting
Taipei, Taiwan
Contact: Pei-Ning Wang, M.D. 011-886-2-2871-2121 ext 3171 pnwang@vghtpe.gov.tw
Principal Investigator: Pei-Ning Wang, M.D.

Sponsors and Collaborators

United Biomedical

UBI Asia

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:	Taipei Veterans General Hospital ( Pei-Ning Wang, M.D., Principal Investigator )
Study ID Numbers:	UBI Protocol V118, Protocol V118-AD
Study First Received:	August 24, 2009
Last Updated:	August 25, 2009
ClinicalTrials.gov Identifier:	NCT00965588 History of Changes
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:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on February 08, 2010