Investigating brain changes in Lewy Body Disease and Alzheimer's Disease
Neurodegeneration and Neuronal Fluctuations in Lewy Body Disease and Alzheimer Disease
This study looks at how brain function, memory, and movement are affected in people with Lewy Body Disease and Alzheimer's, compared to healthy individuals, using brain scans and other tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 50 Years to 95 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT06057909 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Lewy Body Disease or Alzheimer's Disease, as well as healthy individuals who can provide informed consent.
Not a fit: Patients who are not fluent in English or those unable to undergo the required health and cognitive assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of neurodegenerative diseases, potentially enhancing patient care.
How similar studies have performed: Other studies have shown success in using similar methodologies to investigate neurodegenerative diseases, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Scottsdale, Arizona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.