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

NCT04002583 | Active Not Recruiting

• 1 other identifier: 19-003078
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Onset Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Electrographic seizures: Number of subjects with electrographic seizures

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

  48 hours

Study Arms (1)

Early-onset Alzheimer's disease (EOAD) subjects

EXPERIMENTAL

Subjects with mild cognitive impairment due to EOAD will undergo a 48 hour computer assisted ambulatory electroencephalogram

Diagnostic Test: Computer assisted ambulatory electroencephalogram

Interventions

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)

Also known as: CAA-EEG

Early-onset Alzheimer's disease (EOAD) subjects

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Neill Graff-Radford, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: June 28, 2019
• Study Start: February 19, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)