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

January 30, 2026 updated by: Shannon Y. Chiu, Mayo Clinic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Diagnostic test: Magnetic Resonance Imaging
Test that looks at the structure of the brain.
Other Names:
  • MRI
Diagnostic test: Electroencephalography
Non-invasive technique to measure brain waves
Other Names:
  • EEG
Diagnostic test: Electromyography
Technique to evaluate muscle activity
Other Names:
  • 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).
Diagnostic test: Magnetic Resonance Imaging
Test that looks at the structure of the brain.
Other Names:
  • MRI
Diagnostic test: Electroencephalography
Non-invasive technique to measure brain waves
Other Names:
  • EEG
Diagnostic test: Electromyography
Technique to evaluate muscle activity
Other Names:
  • 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).
Diagnostic test: Magnetic Resonance Imaging
Test that looks at the structure of the brain.
Other Names:
  • MRI
Diagnostic test: Electroencephalography
Non-invasive technique to measure brain waves
Other Names:
  • EEG
Diagnostic test: Electromyography
Technique to evaluate muscle activity
Other Names:
  • EMG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diffusion-weighted MRI (dMRI)
Time Frame: Baseline
Measures diffusion of water molecules and cellular-level constraints
Baseline
Electroencephalography (EEG)
Time Frame: Baseline
Measures brain-wave activity
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Shannon Chiu, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-007061
  • K23AG073525 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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