fMRI of Vulnerable Brain Regions in Persons at Risk for A... | NCT00478491

Studies
fMRI of Vulnerable Brain Regions in Persons at Risk for Alzheimer's Disease

NCT00478491

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Oct 27, 2016Estimated

Enrollment

390Actual

Phase

Not provided

Conditions

Magnetic Resonance Imaging
Alzheimer's Disease
Dementia
Adult Children
Risk

Interventions

Not provided

Countries

United States

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
NIH RO1 AG021155A

Status Module

Record Verification Date

Oct 2016

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

Jan 2003

Primary Completion Date

Jun 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

May 22, 2007

First Submission Date that Met QC Criteria

May 22, 2007

First Posted Date

May 24, 2007Estimated

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

Oct 25, 2016

Last Update Posted Date

Oct 27, 2016Estimated

Name	Class
National Institutes of Health (NIH)	NIH
National Institute on Aging (NIA)	NIH

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 study is to investigate the organization of memory and develop future methods for early detection of AD. Using functional magnetic resonance imaging (fMRI), we examine the responsiveness of the brain to memory tasks, specifically focusing on regions of the brain (the mesial temporal lobe and posterior cingulate) that are known to be involved in early stages of Alzheimer's disease (AD). Of interest are differences in brain activation between people with and without a family history of AD and other risk factors.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

390Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Persons with a parent with Alzheimer's disease
2		Persons whose parents survived to old age without memory problems
3		Persons with diagnosed mild cognitive impairment
4		Persons without memory problems

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

MCI Group: Diagnosis of mild cognitive impairment
AD Family History Group: Confirmed family history of Alzheimer's and concurrent enrollment in the Wisconsin Registry for Alzheimer's Prevention (WRAP)
Control Groups: Cognitively healthy and both parents survived past age 70 with no memory problems

Exclusion Criteria:

Claustrophobia
Metallic or electronic implants or devices that are not MRI-safe

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Persons with a parent with Alzheimer's disease will be recruited from the Wisconsin Registry for Alzheimer's Prevention (WRAP). Persons with MCI will be recruited from the UW clinics and satellite clinics. Controls for the above study groups will be recruited from the WRAP and the local community.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sterling C Johnson, PhD	University of Wisconsin/VA GRECC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin - Wisconsin Comprehensive Memory Program		Madison	Wisconsin	53792	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17445294	Result	Ries ML, Jabbar BM, Schmitz TW, Trivedi MA, Gleason CE, Carlsson CM, Rowley HA, Asthana S, Johnson SC. Anosognosia in mild cognitive impairment: Relationship to activation of cortical midline structures involved in self-appraisal. J Int Neuropsychol Soc. 2007 May;13(3):450-61. doi: 10.1017/S1355617707070488.
16738250	Result

ID	Term
D000544	Alzheimer Disease
D003704	Dementia

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies