Prevalence of Epilepsy and Sleep Wake Disorders in Alzheimer Disease

NCT03617497 | Unknown

• 1 other identifier: S61745
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Alzheimer Dementia; Epilepsy; Sleep Wake Disorders

Keywords

Alzheimer Disease; Alzheimer dementia; Epilepsy; Sleep Wake Disorders; EEG; Polysomnography; Foramen ovale electrodes

Outcome Measures

Primary Outcomes (2)

• Epilepsy

  presence of epileptic activity

  during EEG recording

• Sleep wake disorder

  presence of sleep wake disorders

  during polysomnographic recording

Study Arms (3)

Healthy control participants

ACTIVE COMPARATOR

Age- and gender matched healthy participant (n=30) with no cognitive problems and normal amyloid PET scan will undergo 48 hour scalp EEG and polysomnography

Diagnostic Test: scalp EEG and polysomnography

Alzheimer disease

ACTIVE COMPARATOR

Participants with Alzheimer disease (n=100) will undergo 48 hour scalp EEG and polysomnography

Diagnostic Test: scalp EEG and polysomnography

Alzheimer disease with high seizure risk

EXPERIMENTAL

Selected participants with Alzheimer disease, with higher risk for silent hippocampal seizures after 48 hour scalp EEG and polysomnography (e.g. presence of interictal spikes or frequent nocturnal awakenings) (n=15) will undergo scalp EEG with foramen ovale electrodes with polysomnography

Diagnostic Test: scalp EEG and polysomnography; Diagnostic Test: scalp EEG with foramen ovale electrodes with polysomnography

Interventions

scalp EEG and polysomnography DIAGNOSTIC_TEST

48 hour 22 channel EEG with polysomnography

Alzheimer disease; Alzheimer disease with high seizure risk; Healthy control participants

scalp EEG with foramen ovale electrodes with polysomnography DIAGNOSTIC_TEST

long-term scalp EEG with additional foramen ovale electrodes with polysomnography

Alzheimer disease with high seizure risk

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤ 4.
• 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.

You may not qualify if:

• 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
• subdural hematoma
• multiple sclerosis
• history of significant head trauma followed by persistent neurologic deficits
• known structural brain abnormalities
• obstructive sleep apnea syndrome treated with continuous positive airway pressure (CPAP)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven, department of Neurology

Leuven, Vlaams-Brabant, 3000, Belgium

Location

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Related Links

• Mission Lucidity: Decoding Dementia

MeSH Terms

Conditions

Alzheimer Disease; Epilepsy; Sleep Wake Disorders

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Wim Van Paesschen, MD PhD

  UZ and KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Model Details: The investigators will perform 48-hour ambulatory scalp-EEG and polysomnography in 100 participants with Alzheimer disease and 30 age-and gender-matched healthy participants. The investigators will determine the prevalence of 1.) epileptic discharges and epileptic seizures, 2.) sleep wake disorders and 3.) the interaction of epilepsy and sleep wake disorders in these two groups. A subgroup of 15 of these 100 participants with Alzheimer disease, with interictal epileptic spikes or sleep wake disorders (e.g., frequent nocturnal awakenings) will be invited to undergo an invasive EEG study with foramen ovale electrodes to determine the prevalence of hippocampal seizures, which are usually clinically silent and not detected with scalp EEG.

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 6, 2018
• Study Start: December 1, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

BE (1)