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

Last updated: January 27, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nerve Injury

Lewy Body Dementia

Parkinson's Disease

Treatment

Electromyography

Magnetic Resonance Imaging

Electroencephalography

Clinical Study ID

NCT06057909
23-007061
K23AG073525
  • Ages 50-95
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Use English as their primary language.

  • Be willing to undergo health and cognitive assessments, as well as brain MRI and EEGstudy.

  • 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 clinicaldiagnosis made by a board-certified neurologist of Lewy body disease or Alzheimerdisease.

  • All individuals must be capable of providing informed consent and complying with thetrial procedures. Realizing the challenge of obtaining informed consent fromcognitively impaired individuals, time is specifically scheduled to foster aninformative, 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/exclusioncriteria, clinical appropriateness (as determined by participant's physician andproxy/family), as well as by expressed wishes of family members/caregivers/proxydiscussed at each study visit (as appropriate).

  • All participants will receive copies of the signed ICFs (including signatures ofthose obtaining consent).

  • All participants have the right to withdraw from the study at any time.

Exclusion

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 neurologicdisorders including stroke, epilepsy, meningitis/encephalitis, metabolic or toxicencephalopathy, penetrating or severe closed head injury, brain tumor/otherstructural 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 cardiacpacemaker or a neurostimulator including deep brain stimulation), or a certain typeof metallic clip in their body (i.e., an aneurysm clip in the brain), are noteligible for participation in the MRI portion of the study. Individuals whoexperience 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 thefetus, they must have a pregnancy test. Individuals who have a history metalworkinginvolving cutting processes such as grinding, filing, shaving, and threading, orhistory of eye injury involving metal, will also be excluded unless they have hadprior documented radiological clearance for MRI.

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Electromyography
Phase:
Study Start date:
April 05, 2024
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Mayo Clinic Arizona

    Scottsdale, Arizona 85268
    United States

    Active - Recruiting

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