search
Back to results

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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
UB 311
Sponsored by
United Biomedical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, amyloid beta, vaccine

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital (NTUH)
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaccine (UB 311)

Arm Description

Outcomes

Primary Outcome Measures

To evaluate safety and tolerability of the vaccine (UB 311).

Secondary Outcome Measures

To evaluate immunogenicity [and efficacy] of the vaccine (UB 311).

Full Information

First Posted
August 24, 2009
Last Updated
August 22, 2011
Sponsor
United Biomedical
Collaborators
Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00965588
Brief Title
Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Biomedical
Collaborators
Taipei Veterans General Hospital, Taiwan, National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, amyloid beta, vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine (UB 311)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
UB 311
Intervention Description
Single liquid dose by intramuscular route at weeks 0, 4, 12.
Primary Outcome Measure Information:
Title
To evaluate safety and tolerability of the vaccine (UB 311).
Time Frame
Screen, treatment & follow-up: 28-30 weeks
Secondary Outcome Measure Information:
Title
To evaluate immunogenicity [and efficacy] of the vaccine (UB 311).
Time Frame
Screen, treatment & follow-up: 28-30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Jang Chiu, M.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pei-Ning Wang, M.D.
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital (NTUH)
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
17287052
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs