A Study of Neurodegeneration and Neuronal Fluctuations in Lewy Body Disease and Alzheimer's Disease
NCT ID: NCT06057909
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2024-04-05
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
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
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).
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
Healthy Control Group
Subjects identified as a health individual will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG).
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* All participants have the right to withdraw from the study at any time.
* 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.
50 Years
95 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Mayo Clinic
OTHER
Responsible Party
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Shannon Y. Chiu
Principal Investigator
Principal Investigators
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Shannon Chiu, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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23-007061
Identifier Type: -
Identifier Source: org_study_id
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