Back to resultsDaridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease (DARIDOR-ALZ)
Primary Purpose
Alzheimer Disease, Insomnia Disorder, Sleep
Status
Not yet recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Daridorexant 50 mg
Placebo
Polysomnography
Neuropsychological assessment
Questionnaires on sleep and behavioural problems
Actimetrics
24-hour Ambulatory Blood Pressure Monitoring (ABPM
Biomarker assay
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Orexin, Daridorexant, Cognition, Alzheimer, Sleep, Insomnia
Eligibility Criteria
Inclusion criteria : Age [60-85] years old Outpatients Pre-screening: Complaints of dissatisfaction with sleep quantity or quality, despite adequate opportunity for sleep, at least 3 nights per week and for at least 3 months, and Total sleep time causes clinically significant distress or impairment in daytime functioning, and Total sleep time estimated by interview and sleep diary was below 6 hours, on at least 3 nights per week and for at least 1 month before screening, and Insomnia Severity Scale ISI© score ≥ 15 Baseline PSG (at randomization) assessed TST < 6 hours and WASO > 1 hour Diagnosis of MCI and AD patients at an early stage according to the NIA diagnosis criteria (core clinical criteria for MCI, positive biomarker for CSF Aβ42 and neuronal injury (hippocampal and/or temporal atrophy by MRI)) MMSE from 12 to 26 Clinical Dementia Rating CDR from 0.5 to 2 Possible of CNS drugs if stable dose for at least 3 months: anticholinesterase drugs (rivastigmine, donepezil, galantamine) or memantine For a male subject who is not sterilized and is sexually active with a female partner of childbearing potential, no contraceptive methods are needed Non inclusion criteria : Patients significantly dependent on caregivers Institutionalized patients Analphabetism or subjects unable to read or/and write Patients unable to perform the neuropsychological tests Patients unable to complete the study instruments (sleep diary) Planned longer stay outside the region that prevents compliance with the visit schedule Patients who cannot be followed up for at least 2 months History of narcolepsy and/or cataplexy History of drug or alcohol abuse or addiction History of depression or suicidal ideation/attempt or other psychiatric conditions Moderate and severe liver failure PSG baseline evidence of significant/severe sleep-related breathing disorder (defined as >30 apnea/hypopnea episodes per hour) Treatments interfering with sleep-wake patterns Psychotropic drugs: antidepressants (SSRI (e.g. fluoxetine, sertraline, paroxetine…), SNRI (e.g. venlafaxine, duloxetine)), neuroleptics (e.g. clozapine, olanzapine, aripiprazole...), and hypnotics (benzodiazepines, zolpidem, zopiclone) or drug for pain (level 2 (e.g. codeine, tramadol), and level 3 (morphine and derivatives)) Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics (SmPC) Forbidden and restricted concomitant medications: Concomitant CNS-depressant medicinal products CYP3A4 inhibitors CYP3A4 inducers Participation in another clinical trial or administration of an investigational product Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship/curatorship). Subjects not covered by public health insurance Failure to obtain written informed consent after a reflection period
Sites / Locations
- University Hospital, Montpellier
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Daridorexant 50 mg
Placebo-controlled arm
Arm Description
Patients will receive daridorexant 50 mg during one month (Period A or Period B). Daridorexant is an orally administered dual orexin type 1 and type 2 (OX1 and OX2) receptor antagonist (DORA) being developed for the treatment of insomnia.
Patients will receive a placebo matching to daridorexant 50 mg during one month (Period A or Period B).
Outcomes
Primary Outcome Measures
Change in Total Sleep Time (TST).
TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. The TST is measured during polysomnography.
Secondary Outcome Measures
Change in the wake time after sleep onset (WASO)
WASO is defined as the time to wake after initial sleep onset. WASO is measured during overnight sleep laboratory (PSG) assessment and defined as the duration of wakefulness from the onset of persistent sleep.
Change in Latency to Persistent Sleep (LPS)
LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. The LPS is measured during polysomnography.
Measure of sleep time at stage 1-2 during polysomnography
Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography.
Measure of sleep time at stage 3 during polysomnography
Time spent in stage 3 sleep measured in hours and minutes during polysomnography.
Measure of number of wake bouts on the whole night
The number of wake bouts on the whole night will be measured by polysomnography.
Measure of number of wake bouts per quarter of the night
The number of wake bouts per quarter of the night will be measured by polysomnography.
Changes in sleep and wake duration
Average sleep duration (in hours and minutes) over a 7-day period from inclusion to each visit measured by actimetry.
Changes in sleep and wake duration
Average sleep duration (in hours and minutes) over a 7-day period from inclusion to each visit measured by actimetry.
Changes in sleep and wake duration
Average sleep duration (in hours and minutes) over a 7-day period from inclusion to each visit measured by actimetry.
Variations in the results of self-reported questionnaires administered to patients - Insomnia Severity Index (ISI)
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire ISI.
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire assessing the nature, severity of both nighttime and daytime components of insomnia, and impact of insomnia.
Each item is scored 0 (no problem) - 4 (very big problem) with total between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Variations in the results of self-reported questionnaires administered to patients - Insomnia Severity Index (ISI)
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire ISI.
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire assessing the nature, severity of both nighttime and daytime components of insomnia, and impact of insomnia.
Each item is scored 0 (no problem) - 4 (very big problem) with total between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Variations in the results of self-reported questionnaires administered to patients - Insomnia Severity Index (ISI)
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire ISI.
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire assessing the nature, severity of both nighttime and daytime components of insomnia, and impact of insomnia.
Each item is scored 0 (no problem) - 4 (very big problem) with total between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Variations in the results of self-reported questionnaires administered to patients - Epworth Sleepiness Scale (ESS)
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire ESS.
The Epworth Sleepiness Scale (ESS) is a self-report measure of daytime sleepiness in various situations and consists of eight questions. ESS score can range from 0 to 24 (1 to 6 points: Normal sleep; 7 to 8 points: Average sleepiness: 9 to 24 points: Abnormal (possibly pathologic) sleepiness).
Variations in the results of self-reported questionnaires administered to patients - ESS
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire ESS.
The Epworth Sleepiness Scale (ESS) is a self-report measure of daytime sleepiness in various situations and consists of eight questions. ESS score can range from 0 to 24 (1 to 6 points: Normal sleep; 7 to 8 points: Average sleepiness: 9 to 24 points: Abnormal (possibly pathologic) sleepiness).
Variations in the results of self-reported questionnaires administered to patients - Epworth Sleepiness Scale (ESS)
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire ESS.
The Epworth Sleepiness Scale (ESS) is a self-report measure of daytime sleepiness in various situations and consists of eight questions. ESS score can range from 0 to 24 (1 to 6 points: Normal sleep; 7 to 8 points: Average sleepiness: 9 to 24 points: Abnormal (possibly pathologic) sleepiness).
Variations in the results of self-reported questionnaires administered to patients - Insomnia Daytime Symptoms and Impacts (IDSIQ)
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire IDSIQ.
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a patient-reported outcome instrument that assesses daytime functioning in patients with insomnia.
It consists of 14 items (each using a numeric rating scale from 0 to 10) grouped into 3 domains : Alert/Cognition, Mood, and Sleepiness domain reflecting daytime impairment of insomnia.
The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Variations in the results of self-reported questionnaires administered to patients - Insomnia Daytime Symptoms and Impacts (IDSIQ)
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire IDSIQ.
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a patient-reported outcome instrument that assesses daytime functioning in patients with insomnia.
It consists of 14 items (each using a numeric rating scale from 0 to 10) grouped into 3 domains : Alert/Cognition, Mood, and Sleepiness domain reflecting daytime impairment of insomnia.
The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Variations in the results of self-reported questionnaires administered to patients - Insomnia Daytime Symptoms and Impacts (IDSIQ)
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire IDSIQ.
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a patient-reported outcome instrument that assesses daytime functioning in patients with insomnia.
It consists of 14 items (each using a numeric rating scale from 0 to 10) grouped into 3 domains : Alert/Cognition, Mood, and Sleepiness domain reflecting daytime impairment of insomnia.
The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Variations in the results of self-reported questionnaires administered to patients - Sleep Diaries
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire Sleep diaries.
Participants will completed a daily sleep diary (sleep onset latency, wake after sleep onset, early morning awakening, total wake time, total sleep time, and sleep efficiency).
Variations in the results of self-reported questionnaires administered to patients - Sleep Diaries
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire Sleep diaries.
Participants will completed a daily sleep diary (sleep onset latency, wake after sleep onset, early morning awakening, total wake time, total sleep time, and sleep efficiency).
Variations in the results of self-reported questionnaires administered to patients - Sleep Diaries
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire Sleep diaries.
Participants will completed a daily sleep diary (sleep onset latency, wake after sleep onset, early morning awakening, total wake time, total sleep time, and sleep efficiency).
Variations in the results of health assessment questionnaires administered to patients - Neuropsychiatric Inventory (NPI)
The nocturnal agitation will be assessed by using the Neuropsychiatric Inventory (NPI) agitation/aggression domain.
The Neuropsychiatric Inventory (NPI), which consists of 12 items scored with questions, sub-questions, and frequency and severity ratings, is used to assess behavioral changes in Alzheimer disease and other neurodegenerative disorders. The agitation/aggression domain will be evaluated at each visit.
Variations in the results of health assessment questionnaires administered to patients - Neuropsychiatric Inventory (NPI)
The nocturnal agitation will be assessed by using the Neuropsychiatric Inventory (NPI) agitation/aggression domain.
The Neuropsychiatric Inventory (NPI), which consists of 12 items scored with questions, sub-questions, and frequency and severity ratings, is used to assess behavioral changes in Alzheimer disease and other neurodegenerative disorders. The agitation/aggression domain will be evaluated at each visit.
Variations in the results of health assessment questionnaires administered to patients - Neuropsychiatric Inventory (NPI)
The nocturnal agitation will be assessed by using the Neuropsychiatric Inventory (NPI) agitation/aggression domain.
The Neuropsychiatric Inventory (NPI), which consists of 12 items scored with questions, sub-questions, and frequency and severity ratings, is used to assess behavioral changes in Alzheimer disease and other neurodegenerative disorders. The agitation/aggression domain will be evaluated at each visit.
Variations in the results of health assessment questionnaires administered to patients - Beck Depression Inventory (BDI)
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire BDI.
The Beck Depression Inventory (BDI) contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms.
Variations in the results of health assessment questionnaires administered to patients - Beck Depression Inventory (BDI)
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire BDI.
The Beck Depression Inventory (BDI) contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms.
Variations in the results of health assessment questionnaires administered to patients - Beck Depression Inventory (BDI)
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire BDI.
The Beck Depression Inventory (BDI) contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms.
Variations in the results of health assessment questionnaires administered to patients - EuroQoL-5D (EQ5D)
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire EQ5D.
The EuroQol 5-dimensional descriptive system (EQ5D) is a Health Assessment Scale quality of life questionnaire evaluating: mobility, washing and dressing, daily activities, pain and anxiety. Each question has 3 levels of answers: No problem, some problems and important problems. Lower score indicate better outcomes.
The questionnaire also includes a visual analog scale in which the patient quantifies his or her perception of quality of life using a score ranging from the worst imaginable state of health (0) to the best imaginable state of health (100).
Variations in the results of health assessment questionnaires administered to patients - EuroQoL-5D (EQ5D)
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire EQ5D.
The EuroQol 5-dimensional descriptive system (EQ5D) is a Health Assessment Scale quality of life questionnaire evaluating: mobility, washing and dressing, daily activities, pain and anxiety. Each question has 3 levels of answers: No problem, some problems and important problems. Lower score indicate better outcomes.
The questionnaire also includes a visual analog scale in which the patient quantifies his or her perception of quality of life using a score ranging from the worst imaginable state of health (0) to the best imaginable state of health (100).
Variations in the results of health assessment questionnaires administered to patients - EuroQoL-5D (EQ5D)
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire EQ5D.
The EuroQol 5-dimensional descriptive system (EQ5D) is a Health Assessment Scale quality of life questionnaire evaluating: mobility, washing and dressing, daily activities, pain and anxiety. Each question has 3 levels of answers: No problem, some problems and important problems. Lower score indicate better outcomes.
The questionnaire also includes a visual analog scale in which the patient quantifies his or her perception of quality of life using a score ranging from the worst imaginable state of health (0) to the best imaginable state of health (100).
Change in cognition
The Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score will be based on scores from the Mini Mental State Examination (MMSE) (range from 0-30 points), Free and Cued Selective Reminding Test - FCSRT (range from 0-48 points), the Digit Substitution Symbol Test, the Wechsler Intelligence Scale for Adults (WAIS-IV) (range from 0-93 points), the Clinical Dementia Rating Scale (CDR) (range from 0-18 points), and the 2-minute Verbal Fluency Test.
The ADCS-PACC will be measured at each visit. Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
Change in cognition
The Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score will be based on scores from the Mini Mental State Examination (MMSE) (range from 0-30 points), Free and Cued Selective Reminding Test - FCSRT (range from 0-48 points), the Digit Substitution Symbol Test, the Wechsler Intelligence Scale for Adults (WAIS-IV) (range from 0-93 points), the Clinical Dementia Rating Scale (CDR) (range from 0-18 points), and the 2-minute Verbal Fluency Test.
The ADCS-PACC will be measured at each visit. Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
Change in cognition
The Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score will be based on scores from the Mini Mental State Examination (MMSE) (range from 0-30 points), Free and Cued Selective Reminding Test - FCSRT (range from 0-48 points), the Digit Substitution Symbol Test, the Wechsler Intelligence Scale for Adults (WAIS-IV) (range from 0-93 points), the Clinical Dementia Rating Scale (CDR) (range from 0-18 points), and the 2-minute Verbal Fluency Test.
The ADCS-PACC will be measured at each visit. Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
Change in blood pressure
Decrease in blood pressure variability (Systolic and Diastolic) during polysomnography and increase in 24-hour blood pressure monitoring dipping pattern from baseline to the end of each period (Month 1/Month 2) comparing daridorexant 50 mg with placebo.
Change in blood pressure
Change in 24-hour blood pressure (Systolic and Diastolic) monitoring dipping pattern from baseline to the month 6 with daridorexant 50 mg.
Change in blood pressure
Change in 24-hour blood pressure (Systolic and Diastolic) monitoring dipping pattern from baseline to the month 12 with daridorexant 50 mg.
Change in blood AD biomarkers and proinflammatory cytokines levels
Determination of blood AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) levels in serum.
Change in blood AD biomarkers and proinflammatory cytokines levels
Determination of blood AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) levels in serum.
Change in blood AD biomarkers and proinflammatory cytokines levels
Determination of blood AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) levels in serum.
Concentration of CSF AD biomarkers and proinflammatory cytokines
Determination of AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) levels in cerebrospinal fluid (CSF).
Concentration of CSF orexinA/hypocretin
Determination orexinA/hypocretin in cerebrospinal fluid (CSF)
Percentage of Serious Adverse Events Occurring
Safety: rates of serious adverse events between baseline and 12 months.
Full Information
NCT ID
NCT05924425
First Posted
June 4, 2023
Last Updated
June 20, 2023
Sponsor
University Hospital, Montpellier
Collaborators
Idorsia Pharmaceuticals Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05924425
Brief Title
Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
Acronym
DARIDOR-ALZ
Official Title
Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Idorsia Pharmaceuticals Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
DARIDOR-ALZ is a phase IV clinical trial designed to evaluate both the efficacy and safety of daridorexant, a selective dual orexin receptor antagonist that blocks the actions of the orexin neuropeptides at both orexin-1 and orexin-2 receptors, in selected populations of MCI and mild-to-moderate AD patients with insomnia complaints.
Detailed Description
This Phase IV clinical trial is a monocentric, randomized, double-blind, placebo-controlled, 2 way-crossover study (with two periods of one month separated by a washout period range from 5 to 12 days).The study population includes MCI and mild-to-moderate AD patients aged between 60 and 85 years old, with insomnia complaints.
A single-night baseline polysomnography recording will be performed from 11 pm to 7 am at the Montpellier Sleep Unit. After a baseline PSG that assessed TST < 6 hours and WASO > 1 hour, treatment will be assigned using an interactive response technology system.
A randomization list will be generated and will remain confidential until the database is locked. Participants, investigators, and site personnel will be unaware of treatment allocation during the two crossover periods. Patients will be randomized (1:1) to receive daridorexant 50 mg or placebo, without titration, every evening within 30 minutes of going to bed during both treatment periods (Treatment Period A and B) of one-month duration each. Each treatment period will be followed by a one-week (range 5-12 days) washout period at home.
A ten-month open-label (OL) study with daridorexant 50 mg will be proposed to all participants after completing the second treatment period. Based on the experience with another DORA study in patients with mild-to-moderate probable Alzheimer's disease, the investigators would need to recruit 62 patients (including drop-outs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Insomnia Disorder, Sleep
Keywords
Orexin, Daridorexant, Cognition, Alzheimer, Sleep, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
During Period A, patients randomized in the experimental group will receive the treatment every evening within 30 minutes of going to bed during one month. The treatment period will be followed by a one-week (range 5-12 days) washout period at home. During the second period (Period B), these patients will receive the placebo.
During Period A, patients randomized in the control group will receive the placebo every evening within 30 minutes of going to bed during one month. The treatment period will be followed by a one-week (range 5-12 days) washout period at home. During the second period (Period B), these patients will receive the daridorexant 50 mg.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A randomization list will be generated and will remain confidential until the database is locked. Participants, investigators, and site personnel will be unaware of treatment allocation during the two crossover periods (Period A and Period B)
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Daridorexant 50 mg
Arm Type
Experimental
Arm Description
Patients will receive daridorexant 50 mg during one month (Period A or Period B).
Daridorexant is an orally administered dual orexin type 1 and type 2 (OX1 and OX2) receptor antagonist (DORA) being developed for the treatment of insomnia.
Arm Title
Placebo-controlled arm
Arm Type
Placebo Comparator
Arm Description
Patients will receive a placebo matching to daridorexant 50 mg during one month (Period A or Period B).
Intervention Type
Drug
Intervention Name(s)
Daridorexant 50 mg
Intervention Description
Patients randomized in the experimental group will receive the treatment every evening within 30 minutes of going to bed during one month. The treatment period (Period A or Period B) will be followed by a one-week (range 5-12 days) washout period at home.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients randomized in the control group will receive the placebo every evening within 30 minutes of going to bed during one month. The treatment period (Period A or Period B) will be followed by a one-week (range 5-12 days) washout period at home.
Intervention Type
Procedure
Intervention Name(s)
Polysomnography
Intervention Description
A full-night polysomnography recording with blood pressure and heart rate monitoring will be performed at night in the Sleep Laboratory from 11 p.m. to 7 a.m. at baseline (before the randomization) and at the end of each period (Period A/M1, Period B/M2). The recording procedure consists of an electroencephalogram, two electrooculograms, an electromyogram, an electrocardiogram, and a videographic recording. This examination is painless (the sensors are glued to the skin for the duration of the recording). The advantages of this video-polysomnography are based on the evaluation of sleep architecture, micro-arousals, respiratory events and nocturnal motor behavior.
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological assessment
Intervention Description
A full neuropsychological assessment will be performed at inclusion, M1, M2
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires on sleep and behavioural problems
Intervention Description
Questionnaires on sleep and behavioural problems will be performed at inclusion, M1, M2
Intervention Type
Procedure
Intervention Name(s)
Actimetrics
Intervention Description
Measurement of actimetrics for seven days in average (with a minimum of three nights required) prior to the inclusion visit, M1 visit and M2 visit.
Intervention Type
Procedure
Intervention Name(s)
24-hour Ambulatory Blood Pressure Monitoring (ABPM
Intervention Description
Evaluation of the 24-hour hemodynamic profile of a patient by multiple and regular blood pressure and heart rate measurements. The ABP will be monitored at inclusion, M1 and M2
Intervention Type
Other
Intervention Name(s)
Biomarker assay
Intervention Description
Determination of AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) in serum and cerebrospinal fluid (CSF) and dosage of Orexin-A/hypocretin-1 in the CSF
Primary Outcome Measure Information:
Title
Change in Total Sleep Time (TST).
Description
TST is defined as the total sleep time in minutes. The total sleep time is the total amount of sleep time scored during the total recording time. The TST is measured during polysomnography.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Secondary Outcome Measure Information:
Title
Change in the wake time after sleep onset (WASO)
Description
WASO is defined as the time to wake after initial sleep onset. WASO is measured during overnight sleep laboratory (PSG) assessment and defined as the duration of wakefulness from the onset of persistent sleep.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Change in Latency to Persistent Sleep (LPS)
Description
LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch recorded as sleep. The LPS is measured during polysomnography.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Measure of sleep time at stage 1-2 during polysomnography
Description
Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Measure of sleep time at stage 3 during polysomnography
Description
Time spent in stage 3 sleep measured in hours and minutes during polysomnography.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Measure of number of wake bouts on the whole night
Description
The number of wake bouts on the whole night will be measured by polysomnography.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Measure of number of wake bouts per quarter of the night
Description
The number of wake bouts per quarter of the night will be measured by polysomnography.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Changes in sleep and wake duration
Description
Average sleep duration (in hours and minutes) over a 7-day period from inclusion to each visit measured by actimetry.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Changes in sleep and wake duration
Description
Average sleep duration (in hours and minutes) over a 7-day period from inclusion to each visit measured by actimetry.
Time Frame
from baseline to Month 6
Title
Changes in sleep and wake duration
Description
Average sleep duration (in hours and minutes) over a 7-day period from inclusion to each visit measured by actimetry.
Time Frame
from baseline to Month 12
Title
Variations in the results of self-reported questionnaires administered to patients - Insomnia Severity Index (ISI)
Description
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire ISI.
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire assessing the nature, severity of both nighttime and daytime components of insomnia, and impact of insomnia.
Each item is scored 0 (no problem) - 4 (very big problem) with total between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Variations in the results of self-reported questionnaires administered to patients - Insomnia Severity Index (ISI)
Description
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire ISI.
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire assessing the nature, severity of both nighttime and daytime components of insomnia, and impact of insomnia.
Each item is scored 0 (no problem) - 4 (very big problem) with total between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Time Frame
from baseline to Month 6
Title
Variations in the results of self-reported questionnaires administered to patients - Insomnia Severity Index (ISI)
Description
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire ISI.
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire assessing the nature, severity of both nighttime and daytime components of insomnia, and impact of insomnia.
Each item is scored 0 (no problem) - 4 (very big problem) with total between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Time Frame
from baseline to Month 12
Title
Variations in the results of self-reported questionnaires administered to patients - Epworth Sleepiness Scale (ESS)
Description
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire ESS.
The Epworth Sleepiness Scale (ESS) is a self-report measure of daytime sleepiness in various situations and consists of eight questions. ESS score can range from 0 to 24 (1 to 6 points: Normal sleep; 7 to 8 points: Average sleepiness: 9 to 24 points: Abnormal (possibly pathologic) sleepiness).
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Variations in the results of self-reported questionnaires administered to patients - ESS
Description
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire ESS.
The Epworth Sleepiness Scale (ESS) is a self-report measure of daytime sleepiness in various situations and consists of eight questions. ESS score can range from 0 to 24 (1 to 6 points: Normal sleep; 7 to 8 points: Average sleepiness: 9 to 24 points: Abnormal (possibly pathologic) sleepiness).
Time Frame
from baseline to Month 6
Title
Variations in the results of self-reported questionnaires administered to patients - Epworth Sleepiness Scale (ESS)
Description
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire ESS.
The Epworth Sleepiness Scale (ESS) is a self-report measure of daytime sleepiness in various situations and consists of eight questions. ESS score can range from 0 to 24 (1 to 6 points: Normal sleep; 7 to 8 points: Average sleepiness: 9 to 24 points: Abnormal (possibly pathologic) sleepiness).
Time Frame
from baseline to Month 12
Title
Variations in the results of self-reported questionnaires administered to patients - Insomnia Daytime Symptoms and Impacts (IDSIQ)
Description
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire IDSIQ.
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a patient-reported outcome instrument that assesses daytime functioning in patients with insomnia.
It consists of 14 items (each using a numeric rating scale from 0 to 10) grouped into 3 domains : Alert/Cognition, Mood, and Sleepiness domain reflecting daytime impairment of insomnia.
The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Variations in the results of self-reported questionnaires administered to patients - Insomnia Daytime Symptoms and Impacts (IDSIQ)
Description
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire IDSIQ.
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a patient-reported outcome instrument that assesses daytime functioning in patients with insomnia.
It consists of 14 items (each using a numeric rating scale from 0 to 10) grouped into 3 domains : Alert/Cognition, Mood, and Sleepiness domain reflecting daytime impairment of insomnia.
The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time Frame
from baseline to Month 6
Title
Variations in the results of self-reported questionnaires administered to patients - Insomnia Daytime Symptoms and Impacts (IDSIQ)
Description
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire IDSIQ.
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a patient-reported outcome instrument that assesses daytime functioning in patients with insomnia.
It consists of 14 items (each using a numeric rating scale from 0 to 10) grouped into 3 domains : Alert/Cognition, Mood, and Sleepiness domain reflecting daytime impairment of insomnia.
The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time Frame
from baseline to Month 12
Title
Variations in the results of self-reported questionnaires administered to patients - Sleep Diaries
Description
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire Sleep diaries.
Participants will completed a daily sleep diary (sleep onset latency, wake after sleep onset, early morning awakening, total wake time, total sleep time, and sleep efficiency).
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Variations in the results of self-reported questionnaires administered to patients - Sleep Diaries
Description
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire Sleep diaries.
Participants will completed a daily sleep diary (sleep onset latency, wake after sleep onset, early morning awakening, total wake time, total sleep time, and sleep efficiency).
Time Frame
from baseline to Month 6
Title
Variations in the results of self-reported questionnaires administered to patients - Sleep Diaries
Description
Values and variations from baseline of patient-reported outcomes including self-reported questionnaire Sleep diaries.
Participants will completed a daily sleep diary (sleep onset latency, wake after sleep onset, early morning awakening, total wake time, total sleep time, and sleep efficiency).
Time Frame
from baseline to Month 12
Title
Variations in the results of health assessment questionnaires administered to patients - Neuropsychiatric Inventory (NPI)
Description
The nocturnal agitation will be assessed by using the Neuropsychiatric Inventory (NPI) agitation/aggression domain.
The Neuropsychiatric Inventory (NPI), which consists of 12 items scored with questions, sub-questions, and frequency and severity ratings, is used to assess behavioral changes in Alzheimer disease and other neurodegenerative disorders. The agitation/aggression domain will be evaluated at each visit.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Variations in the results of health assessment questionnaires administered to patients - Neuropsychiatric Inventory (NPI)
Description
The nocturnal agitation will be assessed by using the Neuropsychiatric Inventory (NPI) agitation/aggression domain.
The Neuropsychiatric Inventory (NPI), which consists of 12 items scored with questions, sub-questions, and frequency and severity ratings, is used to assess behavioral changes in Alzheimer disease and other neurodegenerative disorders. The agitation/aggression domain will be evaluated at each visit.
Time Frame
from baseline to Month 6
Title
Variations in the results of health assessment questionnaires administered to patients - Neuropsychiatric Inventory (NPI)
Description
The nocturnal agitation will be assessed by using the Neuropsychiatric Inventory (NPI) agitation/aggression domain.
The Neuropsychiatric Inventory (NPI), which consists of 12 items scored with questions, sub-questions, and frequency and severity ratings, is used to assess behavioral changes in Alzheimer disease and other neurodegenerative disorders. The agitation/aggression domain will be evaluated at each visit.
Time Frame
from baseline to Month 12
Title
Variations in the results of health assessment questionnaires administered to patients - Beck Depression Inventory (BDI)
Description
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire BDI.
The Beck Depression Inventory (BDI) contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Variations in the results of health assessment questionnaires administered to patients - Beck Depression Inventory (BDI)
Description
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire BDI.
The Beck Depression Inventory (BDI) contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms.
Time Frame
from baseline to Month 6
Title
Variations in the results of health assessment questionnaires administered to patients - Beck Depression Inventory (BDI)
Description
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire BDI.
The Beck Depression Inventory (BDI) contains 21 items on a 4-point scale from 0 (symptom absent) to 3 (severe symptoms). The minimum score is 0 and the maximum score is 63, with a higher score indicating more severe depressive symptoms.
Time Frame
from baseline to Month 12
Title
Variations in the results of health assessment questionnaires administered to patients - EuroQoL-5D (EQ5D)
Description
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire EQ5D.
The EuroQol 5-dimensional descriptive system (EQ5D) is a Health Assessment Scale quality of life questionnaire evaluating: mobility, washing and dressing, daily activities, pain and anxiety. Each question has 3 levels of answers: No problem, some problems and important problems. Lower score indicate better outcomes.
The questionnaire also includes a visual analog scale in which the patient quantifies his or her perception of quality of life using a score ranging from the worst imaginable state of health (0) to the best imaginable state of health (100).
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Variations in the results of health assessment questionnaires administered to patients - EuroQoL-5D (EQ5D)
Description
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire EQ5D.
The EuroQol 5-dimensional descriptive system (EQ5D) is a Health Assessment Scale quality of life questionnaire evaluating: mobility, washing and dressing, daily activities, pain and anxiety. Each question has 3 levels of answers: No problem, some problems and important problems. Lower score indicate better outcomes.
The questionnaire also includes a visual analog scale in which the patient quantifies his or her perception of quality of life using a score ranging from the worst imaginable state of health (0) to the best imaginable state of health (100).
Time Frame
from baseline to Month 6
Title
Variations in the results of health assessment questionnaires administered to patients - EuroQoL-5D (EQ5D)
Description
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire EQ5D.
The EuroQol 5-dimensional descriptive system (EQ5D) is a Health Assessment Scale quality of life questionnaire evaluating: mobility, washing and dressing, daily activities, pain and anxiety. Each question has 3 levels of answers: No problem, some problems and important problems. Lower score indicate better outcomes.
The questionnaire also includes a visual analog scale in which the patient quantifies his or her perception of quality of life using a score ranging from the worst imaginable state of health (0) to the best imaginable state of health (100).
Time Frame
from baseline to Month 12
Title
Change in cognition
Description
The Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score will be based on scores from the Mini Mental State Examination (MMSE) (range from 0-30 points), Free and Cued Selective Reminding Test - FCSRT (range from 0-48 points), the Digit Substitution Symbol Test, the Wechsler Intelligence Scale for Adults (WAIS-IV) (range from 0-93 points), the Clinical Dementia Rating Scale (CDR) (range from 0-18 points), and the 2-minute Verbal Fluency Test.
The ADCS-PACC will be measured at each visit. Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Change in cognition
Description
The Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score will be based on scores from the Mini Mental State Examination (MMSE) (range from 0-30 points), Free and Cued Selective Reminding Test - FCSRT (range from 0-48 points), the Digit Substitution Symbol Test, the Wechsler Intelligence Scale for Adults (WAIS-IV) (range from 0-93 points), the Clinical Dementia Rating Scale (CDR) (range from 0-18 points), and the 2-minute Verbal Fluency Test.
The ADCS-PACC will be measured at each visit. Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
Time Frame
from baseline to Month 6
Title
Change in cognition
Description
The Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score will be based on scores from the Mini Mental State Examination (MMSE) (range from 0-30 points), Free and Cued Selective Reminding Test - FCSRT (range from 0-48 points), the Digit Substitution Symbol Test, the Wechsler Intelligence Scale for Adults (WAIS-IV) (range from 0-93 points), the Clinical Dementia Rating Scale (CDR) (range from 0-18 points), and the 2-minute Verbal Fluency Test.
The ADCS-PACC will be measured at each visit. Each of the component change scores is divided by the baseline sample standard deviation of that component, to form standardized z scores. These z scores are summed to form the composite. Z Scores could range from -5 to +5 with higher scores indicating less deficit and lower scores indicating greater deficit.
Time Frame
from baseline to Month 12
Title
Change in blood pressure
Description
Decrease in blood pressure variability (Systolic and Diastolic) during polysomnography and increase in 24-hour blood pressure monitoring dipping pattern from baseline to the end of each period (Month 1/Month 2) comparing daridorexant 50 mg with placebo.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Change in blood pressure
Description
Change in 24-hour blood pressure (Systolic and Diastolic) monitoring dipping pattern from baseline to the month 6 with daridorexant 50 mg.
Time Frame
from baseline to Month 6
Title
Change in blood pressure
Description
Change in 24-hour blood pressure (Systolic and Diastolic) monitoring dipping pattern from baseline to the month 12 with daridorexant 50 mg.
Time Frame
from baseline to Month 12
Title
Change in blood AD biomarkers and proinflammatory cytokines levels
Description
Determination of blood AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) levels in serum.
Time Frame
from baseline to the end of each period A/B (Month1/Month2)
Title
Change in blood AD biomarkers and proinflammatory cytokines levels
Description
Determination of blood AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) levels in serum.
Time Frame
from baseline to Month 6
Title
Change in blood AD biomarkers and proinflammatory cytokines levels
Description
Determination of blood AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) levels in serum.
Time Frame
from baseline to Month 12
Title
Concentration of CSF AD biomarkers and proinflammatory cytokines
Description
Determination of AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) levels in cerebrospinal fluid (CSF).
Time Frame
baseline
Title
Concentration of CSF orexinA/hypocretin
Description
Determination orexinA/hypocretin in cerebrospinal fluid (CSF)
Time Frame
baseline
Title
Percentage of Serious Adverse Events Occurring
Description
Safety: rates of serious adverse events between baseline and 12 months.
Time Frame
between baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Age [60-85] years old
Outpatients
Pre-screening:
Complaints of dissatisfaction with sleep quantity or quality, despite adequate opportunity for sleep, at least 3 nights per week and for at least 3 months, and
Total sleep time causes clinically significant distress or impairment in daytime functioning, and
Total sleep time estimated by interview and sleep diary was below 6 hours, on at least 3 nights per week and for at least 1 month before screening, and
Insomnia Severity Scale ISI© score ≥ 15
Baseline PSG (at randomization) assessed TST < 6 hours and WASO > 1 hour
Diagnosis of MCI and AD patients at an early stage according to the NIA diagnosis criteria (core clinical criteria for MCI, positive biomarker for CSF Aβ42 and neuronal injury (hippocampal and/or temporal atrophy by MRI))
MMSE from 12 to 26
Clinical Dementia Rating CDR from 0.5 to 2
Possible of CNS drugs if stable dose for at least 3 months: anticholinesterase drugs (rivastigmine, donepezil, galantamine) or memantine
For a male subject who is not sterilized and is sexually active with a female partner of childbearing potential, no contraceptive methods are needed
Non inclusion criteria :
Patients significantly dependent on caregivers
Institutionalized patients
Analphabetism or subjects unable to read or/and write
Patients unable to perform the neuropsychological tests
Patients unable to complete the study instruments (sleep diary)
Planned longer stay outside the region that prevents compliance with the visit schedule
Patients who cannot be followed up for at least 2 months
History of narcolepsy and/or cataplexy
History of drug or alcohol abuse or addiction
History of depression or suicidal ideation/attempt or other psychiatric conditions
Moderate and severe liver failure
PSG baseline evidence of significant/severe sleep-related breathing disorder (defined as >30 apnea/hypopnea episodes per hour)
Treatments interfering with sleep-wake patterns
Psychotropic drugs: antidepressants (SSRI (e.g. fluoxetine, sertraline, paroxetine…), SNRI (e.g. venlafaxine, duloxetine)), neuroleptics (e.g. clozapine, olanzapine, aripiprazole...), and hypnotics (benzodiazepines, zolpidem, zopiclone) or drug for pain (level 2 (e.g. codeine, tramadol), and level 3 (morphine and derivatives))
Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics (SmPC)
Forbidden and restricted concomitant medications:
Concomitant CNS-depressant medicinal products
CYP3A4 inhibitors
CYP3A4 inducers
Participation in another clinical trial or administration of an investigational product
Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship/curatorship).
Subjects not covered by public health insurance
Failure to obtain written informed consent after a reflection period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yves Dauvilliers, MD
Phone
+33467336361
Email
y-dauvilliers@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Dauvilliers, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Montpellier
City
Montpellier
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves DAUVILLIERS, MD
Phone
+33467336361
Email
y-dauvilliers@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Yves DAUVILLIERS, MD
First Name & Middle Initial & Last Name & Degree
Lucie BARATEAU, MD
First Name & Middle Initial & Last Name & Degree
Karim BENNYS, MD
12. IPD Sharing Statement
Learn more about this trial
Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease
We'll reach out to this number within 24 hrs