48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease

Last updated: March 3, 2026
Sponsor: Mayo Clinic
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Computer assisted ambulatory electroencephalogram

Clinical Study ID

NCT04002583
19-003078
  • Ages 40-64
  • All Genders

Study Summary

Researchers are trying to determine the frequency of seizures and epilepsy in patients with Early-onset Alzheimer's disease (EOAD) using a 48-hour computer assisted ambulatory electroencephalogram.

Eligibility Criteria

Inclusion

Inclusion criteria for EOAD patients will be recruited from the LEADS trial with the following:

  • 40 to 64 years of age

  • Meets NIA-AA criteria for mild cognitive impairment (MCI) due to AD or probable ADdementia.

  • Have a global CDR score of ≤ 1.0

  • Have capacity to provide informed consent (ICF) or has a legal authorizedrepresentative or guardian who provides IC.

  • Amyloid positive status (PET scan with evidence of elevated amyloid)

  • Must have a study partner (informant) who spends a minimum average of 10 hours perweek with the participant (e.g., family member, significant other, friend, andcaregiver) who is generally aware of the participants' daily activities and canprovide information about the participant's cognitive and functional performance. Ifthe participant does not have a study partner who spends 10 face-to-face hours perweek, other arrangements for identifying a viable study partner will be granted on acase-by-case basis by the Site PI.

  • Not pregnant or lactating. Women must be two years post-menopausal, be surgicallysterile, or have a negative pregnancy test prior to each PET scan

  • Fluent in English.

Exclusion

Exclusion Criteria:

  • Meets core clinical criteria for non-AD dementia.

  • Two or more first degree relatives with a history of EOAD suggestive of autosomaldominant transmission, unless known pathogenic mutations in APP, PSEN1, PSEN2 havebeen excluded.

  • Known mutation in an ADAD gene (APP, PSEN1, PSEN2) or other autosomal dominant genesassociated with other neurodegenerative disorders.

  • MRI scans with evidence of infection or focal lesions, cortical strokes, multiplelacunes (single lacune is allowable unless it meets criteria for strategic lacuneaffecting cognition)

  • Any significant systemic illness or unstable medical condition, which could lead todifficulty complying with the protocol (at the discretion of the Site PI)

  • Medical history of a brain disorder other than the disorder causing dementia exceptfor headache.

  • Deemed ineligible by the Site PI for any other reason.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Computer assisted ambulatory electroencephalogram
Phase:
Study Start date:
February 19, 2020
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

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