Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04002583

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 AD dementia.
  • Have a global CDR score of ≤ 1.0
  • Have capacity to provide informed consent (ICF) or has a legal authorized representative 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 per week with the participant (e.g., family member, significant other, friend, and caregiver) who is generally aware of the participants' daily activities and can provide information about the participant's cognitive and functional performance. If the participant does not have a study partner who spends 10 face-to-face hours per week, other arrangements for identifying a viable study partner will be granted on a case-by-case basis by the Site PI.
  • Not pregnant or lactating. Women must be two years post-menopausal, be surgically sterile, or have a negative pregnancy test prior to each PET scan
  • Fluent in English.

Exclusion criteria

  • Meets core clinical criteria for non-AD dementia.
  • Two or more first degree relatives with a history of EOAD suggestive of autosomal dominant transmission, unless known pathogenic mutations in APP, PSEN1, PSEN2 have been excluded.
  • Known mutation in an ADAD gene (APP, PSEN1, PSEN2) or other autosomal dominant genes associated with other neurodegenerative disorders.
  • MRI scans with evidence of infection or focal lesions, cortical strokes, multiple lacunes (single lacune is allowable unless it meets criteria for strategic lacune affecting cognition)
  • Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol (at the discretion of the Site PI)
  • Medical history of a brain disorder other than the disorder causing dementia except for headache.
  • Deemed ineligible by the Site PI for any other reason.

Treatment and study plan

Computer assisted ambulatory electroencephalogram

Diagnostic Test

A portable 16 channel CAA-EEG is used to detect epileptiform abnormalities in a 48 hour ambulatory electroencephalogram (EEG)

Other names: CAA-EEG

Primary outcomes

  1. Electrographic seizures: Number of subjects with electrographic seizures

    Time frame: 48 hours

    Number of subjects with electrographic seizures in 48 hours on computer assisted ambulatory EEG

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Prospective Study Evaluating the Use of 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2019
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.