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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04002583
Enrollment
20
Registered
2019-06-28
Start date
2020-02-19
Completion date
2026-12-01
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Onset Alzheimer Disease

Brief 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.

Interventions

DIAGNOSTIC_TESTComputer assisted ambulatory electroencephalogram

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

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Electrographic seizures: Number of subjects with electrographic seizures48 hoursNumber of subjects with electrographic seizures in 48 hours on computer assisted ambulatory EEG

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNeill Graff-Radford, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026