An interventional study of Overnight polysomnography and blood sample in Alzheimer Disease, Early Onset, sponsored by University Hospital, Toulouse. Status unknown at 1 site in France. Open to participants aged 50 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Diagnostic
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.
Preclinical researchers discovered that the Tg2576 mouse model of Alzheimer Disease (AD) presents epileptiform activity specifically during sleep, with a prominent increase during REM-sleep. This phenotype is specific to AD mice since REM-sleep usually prevents seizures and epileptiform activity in animal models of epilepsy. Preclinical research also evidenced that this epileptic phenotype occurs at very early age in Tg2576 mice, far before the onset of cognitive impairments. Thus, it was hypothesized that patients with AD might present subclinical epileptiform events during sleep with a potential worsening during REM-sleep. If so, it could be used as a specific and early biomarker of AD. Since sleep is involved in memory consolidation processes, preclinical researchers also hypothesized that epileptiform events during sleep might participate to cognitive dysfunction in AD patients.
In order to test this hypothesis, a monocentric clinical study with a protocol consisting of three visits was designed aiming at evaluating seizures and subclinical epileptiform activity - and their consequences on memory - during sleep in 31 patients at early to moderate stages of AD and 31 matched healthy participants. During the first visit, a blood sample is collected of each patient for genetic testing of the ApoE gene before they undergo a high-resolution MRI scan. During the second visit (in the 60 days following the first one) participants first undergo a neuropsychological evaluation including visual, verbal and episodic memory tests before an overnight polysomnography. Following the overnight polysomnography, all subjects (patients and healthy participants) will be tested for the memories acquired the day before in order to evaluate sleep related memory consolidation. During the last visit, participants will fill out questionnaires aiming at evaluating pre-diagnostic lifestyle and they (and one family member if possible) will be interviewed about the presence of symptoms that might indicate an underlying epileptic syndrome for the participant. Healthy subjects will undergo the same procedures except for the blood test from which they will be exempted.
This should allow to evidence sleep related epileptic events, to precise their incidence in AD patients as well as in healthy participants, and to correlate these events to anomalies in brain structure and functional resting state connectivity (MRI) and/or sleep disturbances and/or cognitive decline.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 62 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For all participants:
For AD patients:
For healthy volunteers:
Exclusion Criteria:
For all participants:
For AD patients:
This group contains the 31 (anticipated) participants with a diagnosis of Alzheimer's disease
Diagnostic Test: Overnight polysomnography · Diagnostic Test: blood sample · Diagnostic Test: high-resolution MRI scan · Behavioral: neuropsychological evaluation
This group contains the 31 (anticipated) age and sex -matched healthy controls
Diagnostic Test: Overnight polysomnography · Diagnostic Test: high-resolution MRI scan · Behavioral: neuropsychological evaluation
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
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.
Time frame: Day 2
Number of epileptiform activity according to sleep-wake cycle
Number of epileptiform activity according to sleep-wake cycle in each group
Time frame: Day 2
Frequency of epileptiform activity according to sleep-wake cycle
Frequency of epileptiform activity according to sleep-wake cycle in each group
Time frame: Day 2
lateralization of epileptiform activity according to sleep-wake cycle
lateralization of epileptiform activity according to sleep-wake cycle in each group
Time frame: Day 2
localization of epileptiform activity according to sleep-wake cycle
localization of epileptiform activity according to sleep-wake cycle in each group
Time frame: Day 2
Comparison of sleep characterization between the two groups: total sleep time
total sleep time in hours and minutes
Time frame: Day 2
Comparison of sleep characterization between the two groups: number of sleep cycles
number of sleep cycles
Time frame: Day 2
Comparison of sleep characterization between the two groups: time spent awake during the night
time spent awake during the night
Time frame: Day 2
Comparison of sleep characterization between the two groups: index of micro-awakenings
index of micro-awakenings
Time frame: Day 2
Comparison of sleep characterization between the two groups: distribution of different sleep stages in time
distribution of different sleep stages in time
Time frame: Day 2
Comparison of sleep characterization between the two groups: distribution of different sleep stages in percentage
distribution of different sleep stages in percentage
Time frame: Day 2
Comparison of sleep characterization between the two groups: index of periodic movements
the index of periodic movements
Time frame: Day 2
Comparison of sleep characterization between the two groups: index of hypopnea
index of hypopnea (central and obstructive components)
Time frame: Day 2
Comparison of memory scores at the overnight retention test between the two groups
The memory scores are combined to compute a total score
Time frame: Day 2
symptoms of an underlying epileptic syndrome
The score on the questionnaire aiming at discovering potential symptoms of an underlying epileptic syndrome
Time frame: Month 5
sleep spindles in different sleep stages
The number and the density of sleep spindles in different sleep stages
Time frame: day 2
results of the cognitive reserve inventory (CRIq)
Correlation between the frequency of epileptiform activity, the score on the epilepsy questionnaire and the index of micro-awakenings in the different sleep stages and: the results of the cognitive reserve inventory (CRIq)
Time frame: month 5
speed of cognitive decline.
Correlation between the frequency of epileptiform activity, the score on the epilepsy questionnaire and the index of micro-awakenings in the different sleep stages and: the speed of cognitive decline.
Time frame: month 5
density of sleep spindles in the different sleep stages
Correlation between the frequency of epileptiform activity, the score on the epilepsy questionnaire and the index of micro-awakenings in the different sleep stages and: the density of sleep spindles in the different sleep stages
Time frame: month 5
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University Hospital, Toulouse