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
2 other identifiers
interventional
19
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2009
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 24, 2009
CompletedFirst Posted
Study publicly available on registry
August 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedAugust 23, 2011
August 1, 2011
2.2 years
August 24, 2009
August 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate safety and tolerability of the vaccine (UB 311).
Screen, treatment & follow-up: 28-30 weeks
Secondary Outcomes (1)
To evaluate immunogenicity [and efficacy] of the vaccine (UB 311).
Screen, treatment & follow-up: 28-30 weeks
Study Arms (1)
Vaccine (UB 311)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of mild to moderate Alzheimer's Disease
- Mini-Mental State Examination (MMSE) 15-25
You may not qualify if:
- Major psychiatric disorder
- Severe systemic disease
- Serious adverse reactions to any vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- United Biomedicallead
- Taipei Veterans General Hospital, Taiwancollaborator
- National Taiwan University Hospitalcollaborator
Study Sites (2)
National Taiwan University Hospital (NTUH)
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Related Publications (1)
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. doi: 10.1016/j.vaccine.2007.01.031. Epub 2007 Jan 19.
PMID: 17287052BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming-Jang Chiu, M.D.
National Taiwan University Hospital
- PRINCIPAL INVESTIGATOR
Pei-Ning Wang, M.D.
Taipei Veterans General Hospital, Taiwan
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2009
First Posted
August 25, 2009
Study Start
February 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
August 23, 2011
Record last verified: 2011-08