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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | scalp EEG and polysomnography | 48 hour 22 channel EEG with polysomnography |
| DIAGNOSTIC_TEST | scalp EEG with foramen ovale electrodes with polysomnography | long-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.