Clinical Trials Directory

Trials / Unknown

UnknownNCT03617497

Prevalence of Epilepsy and Sleep Wake Disorders in Alzheimer Disease

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
78 (actual)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Academic / Other
Sex
All
Age
55 Years – 85 Years
Healthy volunteers
Accepted

Summary

Alzheimer disease is the most common of the neurodegenerative diseases. Epilepsy and sleep wake disorders are co-morbid conditions of Alzheimer disease. The investigators propose a prospective study using long-term EEG monitoring in combination with polysomnography to determine prevalence of epilepsy and sleep wake disorders in Alzheimer disease, and correlate these findings with clinical data, Alzheimer disease biomarkers and imaging studies (MRI and amyloid/tau-PET). In selected patients, the investigators will perform EEG studies with foramen ovale electrodes. The ultimate goal is to improve the outcome of patients with Alzheimer disease by early treatment of epilepsy and restoring sleep-wake disturbances.

Detailed description

Alzheimer disease is the most common of the neurodegenerative diseases. Epilepsy and sleep wake disorders are co-morbid conditions of Alzheimer disease, and there is evidence to suggest that the interactions are bidirectional. Neuronal activity promotes the production and secretion of amyloid β, which could actually drive pathogenesis early in the course of Alzheimer disease, and has been described in sleep wake disorders and epilepsy. Epileptic seizures in Alzheimer disease are often subtle, nocturnal and easily overlooked. We propose a prospective study using long-term EEG monitoring in combination with polysomnography to diagnose epilepsy and sleep wake disorders in Alzheimer disease, and correlate these findings with clinical data, Alzheimer disease biomarkers and imaging studies (MRI and amyloid/tau-PET). It is the hypothesis of the investigators that participants with Alzheimer disease and interictal spikes or specified sleep wake disorders (e.g., frequent nocturnal awakenings) during 48 hour scalp EEG and polysomnography are at risk for having hippocampal seizures, which are often clinically silent and not detected on scalp EEG. The investigators will invite 15 of these participants to undergo EEG studies with foramen ovale electrodes to determine the prevalence of these hippocampal seizures. The ultimate goal is to improve the outcome of patients with Alzheimer disease by early treatment of epilepsy and restoring sleep-wake disturbances.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTscalp EEG and polysomnography48 hour 22 channel EEG with polysomnography
DIAGNOSTIC_TESTscalp EEG with foramen ovale electrodes with polysomnographylong-term scalp EEG with additional foramen ovale electrodes with polysomnography

Timeline

Start date
2020-12-01
Primary completion
2024-09-30
Completion
2024-09-30
First posted
2018-08-06
Last updated
2023-10-13

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03617497. Inclusion in this directory is not an endorsement.