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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06057909
Other study ID # 23-007061
Secondary ID K23AG073525
Status Recruiting
Phase
First received
Last updated
Start date April 5, 2024
Est. completion date June 2027

Study information

Verified date April 2024
Source Mayo Clinic
Contact Monica McCarty
Phone (480)301-8549
Email mccarty.monica@mayo.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this research study is to investigate how the brain, memory, thinking, and motor behavior change both in individuals with movement and/or cognitive disorders, as well as healthy individuals. Researchers will look at measurements of memory, thinking, brain wave and muscle activity, daily functioning, and brain scans to learn more about brain disorders such as Alzheimer disease and Lewy body disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date June 2027
Est. primary completion date June 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 95 Years
Eligibility Inclusion Criteria: - Use English as their primary language. - Be willing to undergo health and cognitive assessments, as well as brain MRI and EEG study. - Will be encouraged to have an available study partner (also called a "co-participant") who is familiar with the participant's daily functioning. - This study will be limited to healthy individuals, and patients who have a clinical diagnosis made by a board-certified neurologist of Lewy body disease or Alzheimer disease. - All individuals must be capable of providing informed consent and complying with the trial procedures. Realizing the challenge of obtaining informed consent from cognitively impaired individuals, time is specifically scheduled to foster an informative, supportive interview with the participant and caregiver/legal guardian (typically a spouse or child according to Arizona law and IRB guidelines). - Ongoing participation will be maintained by strict adherence to inclusion/exclusion criteria, clinical appropriateness (as determined by participant's physician and proxy/family), as well as by expressed wishes of family members/caregivers/proxy discussed at each study visit (as appropriate). - All participants will receive copies of the signed ICFs (including signatures of those obtaining consent). - All participants have the right to withdraw from the study at any time. Exclusion Criteria: - Individuals will be excluded if they have significant sensory (visual and hearing) deficits or major medical or psychiatric illnesses which would limit participation. - Participants will also be excluded if they have history of other major neurologic disorders including stroke, epilepsy, meningitis/encephalitis, metabolic or toxic encephalopathy, penetrating or severe closed head injury, brain tumor/other structural lesion, other primary movement disorders (such as essential tremor, dystonia, chorea, multiple system atrophy, progressive supranuclear palsy, corticobasal syndrome). - In addition, as necessitated by the risks of Magnetic Resonance Imaging (MRI), patients who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator including deep brain stimulation), or a certain type of metallic clip in their body (i.e., an aneurysm clip in the brain), are not eligible for participation in the MRI portion of the study. Individuals who experience claustrophobic anxiety will also be excluded from participation. - Women who are or might be pregnant and nursing mothers are not eligible. - If the subject is a woman of childbearing potential, due to unknown risks to the fetus, they must have a pregnancy test. Individuals who have a history metalworking involving cutting processes such as grinding, filing, shaving, and threading, or history of eye injury involving metal, will also be excluded unless they have had prior documented radiological clearance for MRI.

Study Design


Intervention

Diagnostic Test:
Magnetic Resonance Imaging
Test that looks at the structure of the brain.
Electroencephalography
Non-invasive technique to measure brain waves
Electromyography
Technique to evaluate muscle activity

Locations

Country Name City State
United States Mayo Clinic Arizona Scottsdale Arizona

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diffusion-weighted MRI (dMRI) Measures diffusion of water molecules and cellular-level constraints Baseline
Primary Electroencephalography (EEG) Measures brain-wave activity Baseline
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