Development of an EEG Diagnostic for Alzheimer's Disease

NCT04954183 | Completed

• 1 other identifier: 21-000676
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to collect and compare electroencephalogram data from all stages of Alzheimer's disease from preclinical through severe dementia.

Conditions

Mild Cognitive Impairment; Alzheimer Disease; Dementia With Lewy Bodies; Normal Control APOE e4 Carriers and Noncarriers

Outcome Measures

Primary Outcomes (1)

• Obtain electroencephalogram (EEG) data

  Number of EEG data on individuals at all stages of Alzheimer's disease from preclinical through severe dementia.

  1 year

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with moderate to severe dementia, mild stage dementia, amnestic MCI, presymptomatic APOE e4 carriers, and age, sex, and education matched APOE e4 noncarriers will be recruited at Mayo Clinic Arizona to obtain EEG data.

You may qualify if:

• 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).

You may not qualify if:

• Previous stroke.
• Severe head injury.
• Craniotomy.
• Any other potentially confounding neurologic illness (typically anything that causes structural brain damage).

Sponsors & Collaborators

• Mayo Clinic: lead
• Spark Neuro Inc.: collaborator

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Lewy Body Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Erik K. St. Louis, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 8, 2021
• Study Start: October 1, 2021
• Primary Completion: July 24, 2025
• Study Completion: July 24, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)