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

NCT ID: NCT00965588

Last Updated: 2011-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vaccine (UB 311)

Group Type EXPERIMENTAL

UB 311

Intervention Type BIOLOGICAL

Single liquid dose by intramuscular route at weeks 0, 4, 12.

Interventions

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UB 311

Single liquid dose by intramuscular route at weeks 0, 4, 12.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of mild to moderate Alzheimer's Disease
* Mini-Mental State Examination (MMSE) 15-25

Exclusion Criteria

* Major psychiatric disorder
* Severe systemic disease
* Serious adverse reactions to any vaccine
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role collaborator

United Biomedical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming-Jang Chiu, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Pei-Ning Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

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National Taiwan University Hospital (NTUH)

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 17287052 (View on PubMed)

Other Identifiers

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Protocol V118-AD

Identifier Type: -

Identifier Source: secondary_id

UBI Protocol V118

Identifier Type: -

Identifier Source: org_study_id

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