Clinical trial NCT04002583: 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
Official title: A Prospective Study Evaluating the Use of 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Onset Alzheimer Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Electrographic seizures: Number of subjects with electrographic seizures
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Neill Graff-Radford, MD
role: PRINCIPAL_INVESTIGATOR
References: