Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06057909

Conditions

Lewy Body Disease

Alzheimer Disease

Healthy

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Magnetic Resonance Imaging

Electroencephalography

Electromyography

Study Details

Brief 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.

Conditions

Lewy Body Disease

Alzheimer Disease

Healthy

Study ID

NCT06057909

Start date

Apr 5, 2024

Status verified date

Jan, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

Lewy Body Disease Group

Subjects identified by their physician with a diagnosis of Lewy body disease will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).

Alzheimer Disease Group

Subjects identified by their physician with a diagnosis of Alzheimer will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).

Healthy Control Group

Subjects identified as a health individual will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).

Interventions

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

Primary outcome measure

  • Diffusion-weighted MRI (dMRI) [ Time Frame: Baseline ]
  • Electroencephalography (EEG) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Sara Dresler

480-301-6279dresler.sara@mayo.edu

Locations

Mayo Clinic Arizona

Recruiting

Scottsdale, Arizona, United States, 85268

Contacts

Shannon Chiu, MD

chiu.shannon@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-03.