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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-95
SponsorMayo Clinic

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Magnetic Resonance Imaging

    Diagnostic test

    Test that looks at the structure of the brain.

  • Electroencephalography

    Diagnostic test

    Non-invasive technique to measure brain waves

  • Electromyography

    Diagnostic test

    Technique to evaluate muscle activity

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Lewy Body Disease Group3 interventions
Group B: Alzheimer Disease Group3 interventions
Group C: Healthy Control Group3 interventions

Trial outcomes

Primary outcomes

1

Diffusion-weighted MRI (dMRI)

Measures diffusion of water molecules and cellular-level constraints

Time frame
Baseline
2

Electroencephalography (EEG)

Measures brain-wave activity

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Institute on Aging (NIA)

Collaborator