Magnetic Resonance ImagingALZNCT00478491
fMRI of Vulnerable Brain Regions in Persons at Risk for Alzheimer's Disease
An observational study of Magnetic Resonance Imaging and Alzheimer's Disease, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging, Alzheimer's Disease, Dementia
- How many people
- 390 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- Claustrophobia
- Metallic or electronic implants or devices that are not MRI-safe
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Wisconsin Comprehensive Memory Program
Madison, Wisconsin, 53792
About this study
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.
- Conditions
- Magnetic Resonance Imaging, Alzheimer's Disease, Dementia, Adult Children, Risk
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startJan 2003
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sterling C Johnson, PhD, Principal investigator, University of Wisconsin/VA GRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478491
- Sponsor's protocol ID
- 2002-515
- Other IDs
- NIH RO1 AG021155A
- Acronym
- ALZ
- Status last verified
- Oct 2016
- First submitted
- 22 May 2007
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 17445294Johnson 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.
PubMed 16738250Trivedi 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.
PubMed 16412236Ward 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.
PubMed 16321166Ries 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.
PubMed 16102979
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI of Vulnerable Brain Regions in Persons at Risk for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00478491
- Acronym / sponsor ID
- ALZ / 2002-515
- Conditions
- Magnetic Resonance Imaging, Alzheimer's Disease, Dementia, Adult Children, Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Jan 2003
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 24 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Claustrophobia
- Metallic or electronic implants or devices that are not MRI-safe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Results publication: PubMed 17445294Ries 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.
- Results publication: PubMed 16738250Johnson 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.
- Results publication: PubMed 16412236Trivedi 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.
- Results publication: PubMed 16321166Ward 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.
- Results publication: PubMed 16102979Ries 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.
- Website for the Sterling Johnson Imaging LabLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sterling C Johnson, PhD principal investigator
University of Wisconsin/VA GRECC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Resonance Imaging and Alzheimer's Disease, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00478491, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.