Epileptiform Activity During REM Sleep in Alzheimer's Disease
EREMAD
2 other identifiers
interventional
62
1 country
1
Brief Summary
Recent clinical data showed that patients with Alzheimer Disease (AD) might present epilepsy at early stages of the disease (Cretin et al., 2016, Vossel et al., 2016). In mice models of Alzheimer disease, preclinical researchers observed an increase of epileptic events during Rapid Eye Movement (REM) sleep, which is very unusual. This study aims at testing if patients with AD present an exacerbation of epileptic events during REM sleep, which could constitute an early biomarker of the disease. Investigators will evaluate the incidence of epilepsy during each sleep stage in 40 patients with early or moderate forms of AD and in 40 healthy subjects. Investigators will also look for a link between epilepsy during sleep in AD participants and memory performances, brain damage (by using MRI scans) and in the case of patients, the phenotype of the Apolipoprotein E(ApoE) gene.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2019
CompletedFirst Posted
Study publicly available on registry
April 22, 2019
CompletedStudy Start
First participant enrolled
April 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJuly 28, 2021
July 1, 2021
4.1 years
March 29, 2019
July 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Epileptiform activity during REM sleep
the proportion of participants from each group exhibiting a significant epileptiform activity (seizures and/or interictal spikes) during REM sleep. . Epileptiform activity will be defined as either at least one spike, or at least 4 paroxysmal activities.
Day 2
Secondary Outcomes (18)
Number of epileptiform activity according to sleep-wake cycle
Day 2
Frequency of epileptiform activity according to sleep-wake cycle
Day 2
lateralization of epileptiform activity according to sleep-wake cycle
Day 2
localization of epileptiform activity according to sleep-wake cycle
Day 2
Comparison of sleep characterization between the two groups: total sleep time
Day 2
- +13 more secondary outcomes
Study Arms (2)
Alzheimer's Disease patients group
OTHERThis group contains the 31 (anticipated) participants with a diagnosis of Alzheimer's disease
Healthy control group
OTHERThis group contains the 31 (anticipated) age and sex -matched healthy controls
Interventions
Overnight polysomnography with evaluation of each form of epileptiform activity during each vigilance state and memory scores at the overnight retention test
blood sample for genetic testing of the Apolipoprotein E
Evaluation of anomalies in brain structure and functional resting state connectivity
neuropsychological evaluation including episodic memory tests before an overnight polysomnography
Eligibility Criteria
You may qualify if:
- For all participants:
- age from 50 to 90 years old
- affiliated to the French health care system
- For AD patients:
- meeting International Working Group (IWG)-2 criteria for diagnosis
- Mini-Mental State Examination (MMSE) ≥18 (Greco version)
- For healthy volunteers:
- MMSE\>25
- Dubois 5 words test ≥ 9
You may not qualify if:
- For all participants:
- Pregnancy
- people not able to give consent
- contraindication for MRI (metallic body parts, claustrophobia),
- aphasia, apraxia or agnosia
- neurological (other than AD) or any other serious disease (cancer, addiction, systemic disease)
- non treated sleep apnea
- major depression or anxiety for more than 3 months (Beck\>10) or psychiatric disease
- documented epilepsy
- use of neuroleptics (more than one dose per day)
- use of antiepileptics
- use of benzodiazepines at a dose superior or equal to two intakes per day
- use of antidepressants
- restless leg syndrome treated by dopaminergic agonists.
- For AD patients:
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Toulouselead
- Centre de Recherches sur la Cognition Animale (CRCA - UMR5169 CNRS/UPS)collaborator
- Centre de Recherche Cerveau & Cognition (CerCo - UMR5549 CNRS/UPS)collaborator
- Toulouse NeuroImaging Center (ToNIC - UMR 1214 Inserm/UPS)collaborator
- Fondation Plan Alzheimercollaborator
- IHNPS/FHU HoPeScollaborator
Study Sites (1)
Toulouse University Hospital
Toulouse, Occitanie, 31059, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lionel Dahan, PHD
Centre de Recherches sur la Cognition Animale (CRCA), UMR CNRS 5169
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2019
First Posted
April 22, 2019
Study Start
April 29, 2019
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
July 28, 2021
Record last verified: 2021-07