A Study of Neurodegeneration and Neuronal Fluctuations in Lewy Body Disease and Alzheimer's Disease

Mayo Clinic

Status: Enrolling

Conditions: Healthy; Alzheimer Disease; Lewy Body Disease

Treatments: Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Electromyography; Diagnostic Test: Electroencephalography

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06057909

23-007061

K23AG073525 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 50 to 95 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

90 participants in 3 patient groups

Lewy Body Disease Group

Description:

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).

Treatment:

Diagnostic Test: Electroencephalography

Diagnostic Test: Electromyography

Diagnostic Test: Magnetic Resonance Imaging

Alzheimer Disease Group

Description:

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).

Treatment:

Diagnostic Test: Electroencephalography

Diagnostic Test: Electromyography

Diagnostic Test: Magnetic Resonance Imaging

Healthy Control Group

Description:

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

Treatment:

Diagnostic Test: Electroencephalography

Diagnostic Test: Electromyography

Diagnostic Test: Magnetic Resonance Imaging