48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
NCT ID: NCT04002583
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2020-02-19
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Early-onset Alzheimer's disease (EOAD) subjects
Subjects with mild cognitive impairment due to EOAD will undergo a 48 hour computer assisted ambulatory electroencephalogram
Computer assisted ambulatory electroencephalogram
A portable 16 channel CAA-EEG is used to detect epileptiform abnormalities in a 48 hour ambulatory electroencephalogram (EEG)
Interventions
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Computer assisted ambulatory electroencephalogram
A portable 16 channel CAA-EEG is used to detect epileptiform abnormalities in a 48 hour ambulatory electroencephalogram (EEG)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
64 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Neill R. Graff-Radford, M.D.
Principal Investigator
Principal Investigators
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Neill Graff-Radford, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Anton Thomas
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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19-003078
Identifier Type: -
Identifier Source: org_study_id
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