Lewy Body DiseaseNCT06057909
A Study of Neurodegeneration and Neuronal Fluctuations in Lewy Body Disease and Alzheimer's Disease
An observational study of Lewy Body Disease and Alzheimer Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Lewy Body Disease, Alzheimer Disease, Healthy
- What is being tested?
- Magnetic Resonance Imaging, Electroencephalography and Electromyography
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2024to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Arizona
Scottsdale, Arizona, 85268
Shannon Chiu, MD, chiu.shannon@mayo.edu
About this study
Official title: Neurodegeneration and Neuronal Fluctuations in Lewy Body Disease and Alzheimer Disease
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.
- Conditions
- Lewy Body Disease, Alzheimer Disease, Healthy
- Being tested
- Magnetic Resonance Imaging, Electroencephalography, Electromyography
- Medical subject headings
- Lewy Body Disease, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
Also called MRI
Test that looks at the structure of the brain.
ElectroencephalographyDiagnostic test
Also called EEG
Non-invasive technique to measure brain waves
ElectromyographyDiagnostic test
Also called EMG
Technique to evaluate muscle activity
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Electroencephalography; Diagnostic Test: Electromyography | |
| 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). Receives: Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Electroencephalography; Diagnostic Test: Electromyography | |
| Healthy Control Group | Subjects identified as a health individual will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG). Receives: Diagnostic Test: Magnetic Resonance Imaging; Diagnostic Test: Electroencephalography; Diagnostic Test: Electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion-weighted MRI (dMRI)
Measures diffusion of water molecules and cellular-level constraints
Measured: Baseline
Electroencephalography (EEG)
Measures brain-wave activity
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start5 Apr 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Shannon Y. Chiu, Mayo Clinic
- Investigators
- Shannon Chiu, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057909
- Sponsor's protocol ID
- 23-007061
- Other IDs
- K23AG073525
- Status last verified
- Jan 2026
- First submitted
- 21 Sep 2023
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodegeneration and Neuronal Fluctuations in Lewy Body Disease and Alzheimer Disease
- ClinicalTrials.gov ID
- NCT06057909
- Acronym / sponsor ID
- 23-007061
- Conditions
- Lewy Body Disease, Alzheimer Disease, Healthy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lewy Body Disease Group | – | Diagnostic Test: Magnetic Resonance Imaging, Diagnostic Test: Electroencephalography, Diagnostic Test: ElectromyographySubjects 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 | – | Diagnostic Test: Magnetic Resonance Imaging, Diagnostic Test: Electroencephalography, Diagnostic Test: ElectromyographySubjects 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 | – | Diagnostic Test: Magnetic Resonance Imaging, Diagnostic Test: Electroencephalography, Diagnostic Test: ElectromyographySubjects identified as a health individual will have a physical and neurological exam, MRI of brain, electroencephalography (EEG), and electromyography (EMG). |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAlso: MRITest that looks at the structure of the brain. | Diagnostic test | Alzheimer Disease Group, Healthy Control Group, Lewy Body Disease Group |
| ElectroencephalographyAlso: EEGNon-invasive technique to measure brain waves | Diagnostic test | Alzheimer Disease Group, Healthy Control Group, Lewy Body Disease Group |
| ElectromyographyAlso: EMGTechnique to evaluate muscle activity | Diagnostic test | Alzheimer Disease Group, Healthy Control Group, Lewy Body Disease Group |
Primary outcome
Diffusion-weighted MRI (dMRI)
Time frame: Baseline
Measures diffusion of water molecules and cellular-level constraints
Electroencephalography (EEG)
Time frame: Baseline
Measures brain-wave activity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Lewy Body Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shannon Chiu, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lewy Body Disease and Alzheimer Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Dresler (480-301-6279, dresler.sara@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusion-weighted MRI (dMRI) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.