Study to Evaluate Safety, Tolerability and Immunogenicity... | NCT00965588

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

NCT00965588

Sponsor

United Biomedical

Status

Completed

Last Update Posted

Aug 23, 2011Estimated

Enrollment

19Actual

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

UB 311

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Protocol V118-AD

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Aug 24, 2009

First Submission Date that Met QC Criteria

Aug 24, 2009

First Posted Date

Aug 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2011

Last Update Posted Date

Aug 23, 2011Estimated

Name	Class
Taipei Veterans General Hospital, Taiwan	OTHER_GOV
National Taiwan University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaccine (UB 311)	Experimental		Biological: UB 311

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UB 311	Biological	Single liquid dose by intramuscular route at weeks 0, 4, 12.	Vaccine (UB 311)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate safety and tolerability of the vaccine (UB 311).		Screen, treatment & follow-up: 28-30 weeks

Secondary Outcomes

Measure	Description	Time Frame
To evaluate immunogenicity [and efficacy] of the vaccine (UB 311).		Screen, treatment & follow-up: 28-30 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ming-Jang Chiu, M.D.	National Taiwan University Hospital	Principal Investigator
Pei-Ning Wang, M.D.	Taipei Veterans General Hospital, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital (NTUH)		Taipei		10002	Taiwan
Taipei Veterans General Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17287052	Background	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.

ID	Term
D000544	Alzheimer Disease
D058225	Plaque, Amyloid

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases