Investigating brain changes in Lewy Body Disease and Alzheimer's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore how brain function, memory, and motor behavior are affected in individuals with Lewy Body Disease and Alzheimer's Disease, as well as in healthy participants. Researchers will utilize various assessments, including brain scans (MRI), brain wave measurements (EEG), and muscle activity tests (EMG), to gather data on cognitive and physical functioning. The study will involve both patients diagnosed with these neurodegenerative conditions and healthy individuals to compare findings and enhance understanding of these disorders.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic Arizona
  Scottsdale, Arizona, United States Recruiting

Study contacts

• Principal investigator: Shannon Chiu, MD — Mayo Clinic
• Study coordinator: Sara Dresler
• Email: dresler.sara@mayo.edu
• Phone: 480-301-6279

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.