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

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04002583
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
45.4
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Computer assisted ambulatory electroencephalogram
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Prospective Study Evaluating the Use of 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
Actual Study Start Date :
Feb 19, 2020
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Early-onset Alzheimer's disease (EOAD) subjects

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

Diagnostic Test: Computer assisted ambulatory electroencephalogram
A portable 16 channel CAA-EEG is used to detect epileptiform abnormalities in a 48 hour ambulatory electroencephalogram (EEG)
Other Names:
  • CAA-EEG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Electrographic seizures: Number of subjects with electrographic seizures [48 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Florida Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Neill Graff-Radford, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Neill R. Graff-Radford, M.D., Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04002583
    Other Study ID Numbers:
    • 19-003078
    First Posted:
    Jun 28, 2019
    Last Update Posted:
    Jan 4, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Jan 4, 2022