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

Launched by MAYO CLINIC · Jun 27, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how often seizures and epilepsy occur in people with Early-Onset Alzheimer's Disease (EOAD). To do this, researchers will use a special test called a 48-hour ambulatory electroencephalogram (EEG), which monitors brain activity while the patient goes about their daily life. The goal is to learn more about how these conditions affect individuals with EOAD.

To join the study, participants need to be between 40 and 64 years old and diagnosed with mild cognitive impairment or probable Alzheimer's dementia. They must also have a positive amyloid status, which means a brain scan has shown certain changes related to Alzheimer's. It's important for participants to have a study partner, like a family member or friend, who spends time with them and can provide insights about their daily activities. If you're considering this trial, it's essential to know that it is currently recruiting participants, and those interested should be fluent in English and not pregnant or nursing. Participants can expect to wear a portable EEG device for 48 hours, allowing researchers to gather valuable information while they continue their regular routines.

Gender

ALL

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.