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Search / Trial NCT04954183

Development of an EEG Diagnostic for Alzheimer's Disease

Launched by MAYO CLINIC · Jun 29, 2021

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

Patients with diagnoses of sporadic and late onset Alzheimer's disease dementia, MCI, and DLB evaluated by a dementia subspecialist will meet published diagnostic criteria, and EEGs will be obtained through written informed consent. Regarding presymptomatic patients, we have previously shown that the mean age of MCI diagnosis in our cohort is 73 years and that preclinical cognitive decline begins as much as 20 years before clinical diagnosis but is also affected by APOE genotype. Eligibility therefore will include unimpaired APOE e4/4 homozygotes age 65-75 and APOE e3/4 heterozygotes age 75...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 5 individuals with moderate to severe dementia, 5 with mild stage dementia, 5 with amnestic MCI, 5 presymptomatic APOE e4 carriers, and 5 age, sex, and education matched APOE e4 noncarriers. Additionally we will include a group of 5 patients with mild to moderate stage dementia with Lewy bodies (DLB), the second most common degenerative dementia, to explore differences from clinically typical Alzheimer's disease patients given the known clinical differences in EEG dysrhythmic severity between them (total of 30).
  • Unimpaired APOE e4/4 homozygotes age 65-75 and APOE e3/4 heterozygotes age 75-85 for the preclinical AD subset and age, sex, and education matched APOE e4 noncarriers for the unaffected controls.
  • Biomarker confirmation for preclinical diagnosis will be utilized to the extent possible (a subset of 130 members of our cohort have undergone amyloid-PET resulting in approximately 45 who are amyloid positive).
  • Exclusion Criteria:
  • Previous stroke.
  • Severe head injury.
  • Craniotomy.
  • Any other potentially confounding neurologic illness (typically anything that causes structural brain damage).
  • Psychoactive medication use will not be an absolute exclusionary criterion in patients with moderate to severe dementia but patients who are relatively drug-free will be prioritized to the extent they are available within the study period.
  • Psychoactive drug use will be exclusionary in the prospectively obtained clinical patients.

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Scottsdale, Arizona, United States

Patients applied

0 patients applied

Trial Officials

Erik K. St. Louis, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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