Alzheimer's DiseaseNCT01615666
A Composite MR Neuroimaging Marker for Alzheimer's Disease
An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to use a functional MRI (fMRI) index to compare the brain activity of healthy volunteers to that of people with mild cognitive impairment (MCI) and Alzheimer's disease. The ultimate goal is to develop an early diagnostic tool for Alzheimer's disease. The study hypotheses are: 1. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment, Frontotemporal Dementia
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jan 2016
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Alzheimer's, non-Alzheimer's dementia, and mild cognitive impairment (MCI) participants recruited from the Medical College of Wisconsin/Froedtert Hospital Memory Disorders Clinic * MCI and healthy volunteers recruited from the community
Who may be able to join
- 60 years of age or older (50 years of age or older for frontotemporal dementia patients)
- Normal memory, mild cognitive impairment (memory loss that does not significantly affect normal daily activities), or clinical diagnosis of Alzheimer's disease or frontotemporal dementia (includes primary progressive aphasia)
- Right-handed
- General good physical health
Who cannot join
- History of stroke or neurological disease (other than Alzheimer's disease or frontotemporal dementia)
- Seizures or head injury with loss of consciousness within the last five years
- Ferrous (magnetic) or electronic implants (due to the magnet in the MRI scanner)
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226
About this study
The purpose of this study is to use a functional MRI (fMRI) index to compare the brain activity of healthy volunteers to that of people with mild cognitive impairment (MCI) and Alzheimer's disease. The ultimate goal is to develop an early diagnostic tool for Alzheimer's disease.
The study hypotheses are:
- The fMRI index will differentiate between Alzheimer's disease, non-Alzheimer's dementia, and healthy volunteers;
- The fMRI index will distinguish participants with MCI who convert to Alzheimer's disease from those who convert to a non-Alzheimer's dementia and those who remain stable;
- MCI participants with a lower fMRI index at baseline who convert will progress to Alzheimer's sooner than those with a higher fMRI index, and MCI participants with a faster rate of fMRI index decline who convert will have an earlier onset of Alzheimer's disease.
Read the detailed description
The onset of Alzheimer's disease is insidious and the boundary between normal aging and Alzheimer's disease is blurred. In order to prevent and treat Alzheimer's disease, the investigators must be able to mark its preclinical stage, before brain damage becomes irreversible. There is a substantial body of research dealing with predictive markers of Alzheimer's disease in individuals with mild cognitive impairment (MCI). Despite these advances, however, researchers have not had enough evidence to recommend specific techniques that mark preclinical Alzheimer's disease. This new functional MRI (fMRI) index may fill this gap.
Participants will have two visits, one for memory testing and neurological examination, and one for an MRI scan. Each visit will take approximately 1½ hours. For volunteers who wish to do so, all study procedures may be completed in a single visit. Participants with MCI will be followed annually.
The investigators are currently enrolling healthy volunteers, as well as individuals with MCI (memory loss that does not significantly affect normal daily activities), Alzheimer's disease, and frontotemporal dementia (includes primary progressive aphasia).
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment, Frontotemporal dementia, fMRI, functional neuroimaging, Memory
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Frontotemporal 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 |
|---|---|---|
| Healthy volunteers | Healthy volunteers who will undergo functional MRI (fMRI) to obtain fMRI index | |
| Alzheimer's disease | Individuals with Alzheimer's disease who will undergo functional MRI (fMRI) to obtain fMRI index | |
| Non-Alzheimer's dementia | Individuals with Non-Alzheimer's dementia who will undergo functional MRI (fMRI) to obtain fMRI index | |
| Amnestic mild cognitive impairment | Individuals with Amnestic mild cognitive impairment who will undergo functional MRI (fMRI) to obtain fMRI index | |
| Nonamnestic mild cognitive impairment | Individuals with Nonamnestic mild cognitive impairment who will undergo functional MRI (fMRI) to obtain fMRI index |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the sensitivity and specificity of the MRN Index as an AD biomarker.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startMar 2009
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: This was never a clinical trial and should never have been approved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Shi-Jiang Li, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615666
- Sponsor's protocol ID
- 2R01AG020279-06A2
- Other IDs
- 2R01AG020279-06A2
- Status last verified
- Jan 2016
- First submitted
- 6 Jun 2012
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Composite MR Neuroimaging Marker for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01615666
- Acronym / sponsor ID
- 2R01AG020279-06A2
- Keywords
- Alzheimer's disease, Mild Cognitive Impairment, Frontotemporal dementia, fMRI, functional neuroimaging, Memory
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This was never a clinical trial and should never have been approved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Mar 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 8 Jun 2012 (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 use a functional MRI (fMRI) index to compare the brain activity of healthy volunteers to that of people with mild cognitive impairment (MCI) and Alzheimer's disease. The ultimate goal is to develop an early diagnostic tool for Alzheimer's disease.
The study hypotheses are:
- The fMRI index will differentiate between Alzheimer's disease, non-Alzheimer's dementia, and healthy volunteers;
- The fMRI index will distinguish participants with MCI who convert to Alzheimer's disease from those who convert to a non-Alzheimer's dementia and those who remain stable;
- MCI participants with a lower fMRI index at baseline who convert will progress to Alzheimer's sooner than those with a higher fMRI index, and MCI participants with a faster rate of fMRI index decline who convert will have an earlier onset of Alzheimer's disease.
Detailed description
The onset of Alzheimer's disease is insidious and the boundary between normal aging and Alzheimer's disease is blurred. In order to prevent and treat Alzheimer's disease, the investigators must be able to mark its preclinical stage, before brain damage becomes irreversible. There is a substantial body of research dealing with predictive markers of Alzheimer's disease in individuals with mild cognitive impairment (MCI). Despite these advances, however, researchers have not had enough evidence to recommend specific techniques that mark preclinical Alzheimer's disease. This new functional MRI (fMRI) index may fill this gap.
Participants will have two visits, one for memory testing and neurological examination, and one for an MRI scan. Each visit will take approximately 1½ hours. For volunteers who wish to do so, all study procedures may be completed in a single visit. Participants with MCI will be followed annually.
The investigators are currently enrolling healthy volunteers, as well as individuals with MCI (memory loss that does not significantly affect normal daily activities), Alzheimer's disease, and frontotemporal dementia (includes primary progressive aphasia).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –Healthy volunteers who will undergo functional MRI (fMRI) to obtain fMRI index |
| Alzheimer's disease | – | –Individuals with Alzheimer's disease who will undergo functional MRI (fMRI) to obtain fMRI index |
| Non-Alzheimer's dementia | – | –Individuals with Non-Alzheimer's dementia who will undergo functional MRI (fMRI) to obtain fMRI index |
| Amnestic mild cognitive impairment | – | –Individuals with Amnestic mild cognitive impairment who will undergo functional MRI (fMRI) to obtain fMRI index |
| Nonamnestic mild cognitive impairment | – | –Individuals with Nonamnestic mild cognitive impairment who will undergo functional MRI (fMRI) to obtain fMRI index |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Alzheimer's, non-Alzheimer's dementia, and mild cognitive impairment (MCI) participants recruited from the Medical College of Wisconsin/Froedtert Hospital Memory Disorders Clinic * MCI and healthy volunteers recruited from the community
Key inclusion criteria (4 listed)
- 60 years of age or older (50 years of age or older for frontotemporal dementia patients)
- Normal memory, mild cognitive impairment (memory loss that does not significantly affect normal daily activities), or clinical diagnosis of Alzheimer's disease or frontotemporal dementia (includes primary progressive aphasia)
- Right-handed
- General good physical health
Key exclusion criteria (4 listed)
- History of stroke or neurological disease (other than Alzheimer's disease or frontotemporal dementia)
- Seizures or head injury with loss of consciousness within the last five years
- Ferrous (magnetic) or electronic implants (due to the magnet in the MRI scanner)
- Claustrophobia
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
To determine the sensitivity and specificity of the MRN Index as an AD biomarker.
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
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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.
Shi-Jiang Li, PhD principal investigator
Medical College of Wisconsin
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 Alzheimer's Disease and Mild Cognitive Impairment, run by Medical College of Wisconsin 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 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 14 Jan 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 was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
To determine the sensitivity and specificity of the MRN Index as an AD biomarker. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2016.