A Study of Neurodegeneration and Neuronal Fluctuations in Lewy Body Disease and Alzheimer's Disease
Neurodegeneration and Neuronal Fluctuations in Lewy Body Disease and Alzheimer Disease
2 other identifiers
observational
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
April 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
February 3, 2026
January 1, 2026
3.2 years
September 21, 2023
January 30, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Diffusion-weighted MRI (dMRI)
Measures diffusion of water molecules and cellular-level constraints
Baseline
Electroencephalography (EEG)
Measures brain-wave activity
Baseline
Study Arms (3)
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
Test that looks at the structure of the brain.
Non-invasive technique to measure brain waves
Technique to evaluate muscle activity
Eligibility Criteria
This study will include healthy individuals, and patients who have a clinical diagnosis made by a board-certified neurologist of Lewy body disease or Alzheimer disease.
You may qualify if:
- 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).
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Mayo Clinic Arizona
Scottsdale, Arizona, 85268, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon Chiu, MD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 21, 2023
First Posted
September 28, 2023
Study Start
April 5, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
February 3, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share