NCT03617497: PESAD

Prevalence of Epilepsy and Sleep Wake Disorders in Alzheimer Disease

Status unknown NA Last updated 13 October 2023

What this trial tests

NA trial testing scalp EEG and polysomnography in Alzheimer Disease in 78 participants. Status unknown.

Timeline

1 December 2020

Primary endpoint
30 September 2024

30 September 2024

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	factorial
Masking	none
Primary purpose	diagnostic
Enrollment	78
Start date	1 December 2020
Primary completion	30 September 2024
Estimated completion	30 September 2024
Sites	1 location across Belgium

Drugs / interventions tested

• scalp EEG and polysomnography
• scalp EEG with foramen ovale electrodes with polysomnography

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Alzheimer Dementia — all drugs for Alzheimer Dementia →
• Epilepsy — all drugs for Epilepsy →
• Sleep Wake Disorders — all drugs for Sleep Wake Disorders →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

Adults 55 to 85, any sex, with Alzheimer Disease or Alzheimer Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The power of ECG in multimodal patient-specific seizure monitoring: Added value to an EEG-based detector using limited channels.
   Vandecasteele K, De Cooman T, Chatzichristos C, Cleeren E, et al · · 2021 · cited 38× · PMID 34240748 · DOI 10.1111/epi.16990
2. Subclinical epileptiform activity and sleep disturbances in Alzheimer's disease.
   Devulder A, Macea J, Kalkanis A, De Winter FL, et al · · 2023 · cited 14× · PMID 37950422 · DOI 10.1002/brb3.3306
3. Epileptic activity on foramen ovale electrodes is associated with sleep and tau pathology in Alzheimer's disease.
   Devulder A, Vanderlinden G, Van Langenhoven L, Testelmans D, et al · · 2025 · cited 13× · PMID 38990981 · DOI 10.1093/brain/awae231
4. Alzheimer's disease and epilepsy: shared neuropathology guides current and future treatment strategies.
   Lu O, Kouser T, Skylar-Scott IA. · · 2023 · cited 7× · PMID 37936917 · DOI 10.3389/fneur.2023.1241339
5. Wearable sleep recording augmented by artificial intelligence for Alzheimer's disease screening.
   Heremans ERM, Devulder A, Borzée P, Vandenberghe R, et al · · 2025 · cited 3× · PMID 40346113 · DOI 10.1038/s41514-025-00219-y
6. A case report about focal status epilepticus as first presentation in Alzheimer's disease: finding the culprit.
   Devulder A, Vanderlinden G, Cleeren E, Goovaerts V, et al · · 2024 · cited 1× · PMID 39696024 · DOI 10.1186/s12883-024-03979-4