Healthy Clinical Trial
Official title:
Neurodegeneration and Neuronal Fluctuations in Lewy Body Disease and Alzheimer Disease
Verified date | April 2024 |
Source | Mayo Clinic |
Contact | Monica McCarty |
Phone | (480)301-8549 |
mccarty.monica[@]mayo.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | June 2027 |
Est. primary completion date | June 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 95 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diffusion-weighted MRI (dMRI) | Measures diffusion of water molecules and cellular-level constraints | Baseline | |
Primary | Electroencephalography (EEG) | Measures brain-wave activity | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |