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Clinical Trials/NCT03617497
NCT03617497
Active, not recruiting
Not Applicable

Prevalence of Epilepsy and Sleep Wake Disorders in Alzheimer Disease

Universitaire Ziekenhuizen KU Leuven1 site in 1 country78 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
78
Locations
1
Primary Endpoint
Epilepsy
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
September 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof Dr W Van Paesschen

Professor Doctor

Universitaire Ziekenhuizen KU Leuven

Eligibility Criteria

Inclusion Criteria

  • Participant must be able to understand the nature of the study and has the opportunity to have any questions answered. The participant has voluntarily signed the independent Review Board (IRB)/independent Ethics Committee (IEC) approved Informed Consent, prior to the conduct of any study procedures. If the participant is not fully competent, full informed consent must be obtained from a representative and assent must be obtained from the participant.
  • Participant who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable Alzheimer Disease, and have:
  • Clinical Dementia Rating (CDR)-Global Score of 0.5
  • A Mini-Mental State Examination (MMSE) score of 22 to 30
  • Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS-DMI) score of 85 or lower
  • Participant has a positive amyloid Positron Emission Tomography (PET) scan.
  • Participant has a Modified Hachinski Ischemic Scale (MHIS) score of ≤
  • Participant has an identified, reliable, study partner (e.g., family member), who has frequent contact with the participant and who will provide information as to the participant's cognitive and functional abilities.

Exclusion Criteria

  • Participant has evidence of any other clinically significant neurological disorder other than Alzheimer disease, including but not limited to:
  • Parkinson's disease
  • vascular dementia
  • significant cerebrovascular abnormalities
  • frontal-temporal dementia
  • Huntington's disease
  • normal pressure hydrocephalus
  • brain tumor
  • progressive supranuclear palsy
  • seizure disorder

Outcomes

Primary Outcomes

Epilepsy

Time Frame: during EEG recording

presence of epileptic activity

Sleep wake disorder

Time Frame: during polysomnographic recording

presence of sleep wake disorders

Study Sites (1)

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