Monitoring brain activity in early onset Alzheimer's disease
A Prospective Study Evaluating the Use of 48-hour Ambulatory EEG Monitoring in Early Onset Alzheimer's Disease
This study is testing how often seizures happen in people with early onset Alzheimer's disease by using a special brain scan that monitors brain activity for two days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 64 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT04002583 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the frequency of seizures and epilepsy in patients diagnosed with Early Onset Alzheimer's Disease (EOAD) by utilizing a 48-hour computer-assisted ambulatory electroencephalogram (EEG). Participants will be recruited from the LEADS trial and must meet specific criteria, including age, cognitive impairment status, and amyloid positivity. The EEG monitoring will help researchers understand the neurological aspects of EOAD and its potential complications.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 64 with mild cognitive impairment or probable Alzheimer's dementia and a confirmed amyloid positive status.
Not a fit: Patients who are not diagnosed with Early Onset Alzheimer's Disease or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of seizure prevalence in EOAD, leading to better management and treatment strategies for affected patients.
How similar studies have performed: While studies on EEG monitoring in Alzheimer's patients exist, this specific approach focusing on early onset cases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Neill Graff-Radford, MD — Mayo Clinic
- Study coordinator: Sabrina Bunn
- Email: bunn.sabrina@mayo.edu
- Phone: 904-953-3930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.