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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 95 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the brain, memory, thinking, movement, and daily activities change over time. It is for healthy people and people with Lewy body disease or Alzheimer's disease. Researchers will use brain scans and tests of memory, thinking, brain waves, and muscle activity.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • English must be your main language.
  • You must be healthy or have Lewy body disease or Alzheimer's disease diagnosed by a board-certified neurologist, a doctor who treats brain and nerve disorders.
  • You must agree to health and thinking tests, an MRI brain scan, and an EEG, which records brain waves.
  • You are encouraged to have a study partner who knows about your daily activities.
  • You must be able to understand and agree to join the study and follow its steps.
  • To stay in the study, you must keep meeting its rules. Your doctor and family or representative will help decide if staying is right for you.
  • If you could become pregnant, you must have a pregnancy test.

Who can't join

  • Major vision or hearing problems, or serious physical or mental health conditions, that would limit taking part.
  • A history of other major brain or nerve disorders, such as stroke, seizures, brain infections, brain damage from chemicals or body changes, serious head injury, or a brain tumor.
  • Other major movement disorders, such as essential tremor or disorders that cause muscle twisting, unwanted movements, stiffness, or balance problems.
  • An implanted electrical device, such as a pacemaker or brain stimulator, or certain metal clips in your body will keep you from the MRI part of the study.
  • Anxiety in small or closed spaces.
  • Being pregnant, possibly pregnant, or breastfeeding.
  • Past work cutting or grinding metal, or a metal injury to your eye, unless you have documented imaging clearance showing you can safely have an MRI.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

AZ