Alzheimer's DiseaseNCT01777789
The Role of Mid-Life Adiposity in Functional Brain Connectivity
An observational study of Alzheimer's Disease, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of the study is to use functional MRI (fMRI) to measure brain connectivity in middle-aged individuals with different levels of body fat. The ultimate goal of this research is to develop an early diagnostic tool for Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Feb 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers from the community
Who may be able to join
- 45-65 years of age
- Normal memory
- Right-handed
- General good physical health
Who cannot join
- History of stroke or neurological disease
- 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
- More detailed inclusion/exclusion criteria must be met in order to qualify for the study. The study coordinator will determine eligibility.
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 the study is to use functional MRI (fMRI) to measure brain connectivity in middle-aged individuals with different levels of body fat. The ultimate goal of this research is to develop an early diagnostic tool for Alzheimer's disease.
Read the detailed description
Participants will have one visit for:
- Blood draw
- Body composition scan
- Cognitive screen
- Neurological exam
- MRI scan
The visit will take approximately 3 hours.
- Conditions
- Alzheimer's Disease
- Keywords
- fMRI, Dementia, Alzheimer's disease, functional neuroimaging, Memory
- Medical subject headings
- Alzheimer Disease, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain connectivity measured by fMRI
Measured: One visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: This is a basic research study with no clinical data to report
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
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piero Antuono, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777789
- Sponsor's protocol ID
- PRO16109
- Status last verified
- Feb 2016
- First submitted
- 24 Jan 2013
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Mid-Life Adiposity in Functional Brain Connectivity
- ClinicalTrials.gov ID
- NCT01777789
- Acronym / sponsor ID
- PRO16109
- Conditions
- Alzheimer's Disease
- Keywords
- fMRI, Dementia, Alzheimer's disease, functional neuroimaging, Memory
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This is a basic research study with no clinical data to report
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 Jan 2013 (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 the study is to use functional MRI (fMRI) to measure brain connectivity in middle-aged individuals with different levels of body fat. The ultimate goal of this research is to develop an early diagnostic tool for Alzheimer's disease.
Detailed description
Participants will have one visit for:
- Blood draw
- Body composition scan
- Cognitive screen
- Neurological exam
- MRI scan
The visit will take approximately 3 hours.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers from the community
Key inclusion criteria (4 listed)
- 45-65 years of age
- Normal memory
- Right-handed
- General good physical health
Key exclusion criteria (5 listed)
- History of stroke or neurological disease
- 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
- More detailed inclusion/exclusion criteria must be met in order to qualify for the study. The study coordinator will determine eligibility.
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
Brain connectivity measured by fMRI
Time frame: One visit
Results and safety
The study was stopped early (reason given: This is a basic research study with no clinical data to report). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 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.
Piero Antuono, MD 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, 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 5 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: stopped early, as of the sponsor's last update on 9 Feb 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 stopped early (reason given: This is a basic research study with no clinical data to report). Results are not available in the source record.
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?
Brain connectivity measured by fMRI (time frame: One visit). 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 9 Feb 2016.