- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00478491
fMRI of Vulnerable Brain Regions in Persons at Risk for Alzheimer's Disease (ALZ)
October 25, 2016 updated by: University of Wisconsin, Madison
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
390
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin - Wisconsin Comprehensive Memory Program
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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1
Persons with a parent with Alzheimer's disease
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2
Persons whose parents survived to old age without memory problems
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3
Persons with diagnosed mild cognitive impairment
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4
Persons without memory problems
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sterling C Johnson, PhD, University of Wisconsin/VA GRECC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Johnson SC, Schmitz TW, Trivedi MA, Ries ML, Torgerson BM, Carlsson CM, Asthana S, Hermann BP, Sager MA. The influence of Alzheimer disease family history and apolipoprotein E epsilon4 on mesial temporal lobe activation. J Neurosci. 2006 May 31;26(22):6069-76. doi: 10.1523/JNEUROSCI.0959-06.2006.
- Trivedi MA, Schmitz TW, Ries ML, Torgerson BM, Sager MA, Hermann BP, Asthana S, Johnson SC. Reduced hippocampal activation during episodic encoding in middle-aged individuals at genetic risk of Alzheimer's disease: a cross-sectional study. BMC Med. 2006 Jan 13;4:1. doi: 10.1186/1741-7015-4-1.
- Ward MA, Carlsson CM, Trivedi MA, Sager MA, Johnson SC. The effect of body mass index on global brain volume in middle-aged adults: a cross sectional study. BMC Neurol. 2005 Dec 2;5:23. doi: 10.1186/1471-2377-5-23.
- Ries ML, Schmitz TW, Kawahara TN, Torgerson BM, Trivedi MA, Johnson SC. Task-dependent posterior cingulate activation in mild cognitive impairment. Neuroimage. 2006 Jan 15;29(2):485-92. doi: 10.1016/j.neuroimage.2005.07.030. Epub 2005 Aug 15.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
May 22, 2007
First Submitted That Met QC Criteria
May 22, 2007
First Posted (Estimate)
May 24, 2007
Study Record Updates
Last Update Posted (Estimate)
October 27, 2016
Last Update Submitted That Met QC Criteria
October 25, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002-515
- NIH RO1 AG021155A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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