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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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Alzheimer's disease (AD) is characterised by a progressive loss of memory and cognitive function. In the early stages of AD, there is a progressive accumulation of molecules: β-amyloid peptides (Aβ) in the brain. There is a link between the accumulation of Aβ peptides and the deterioration of sleep, but current knowledge does not confirmed this link. The objective of this study is to define whether there is a link between cognitive decline and sleep disorders. If a correlation is found, this could allow earlier treatment of sleep disorders in the longer term in order to slow the development of AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Alzheimer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polysomnography | Procedure | Polysomnography will be performed for 24 hours at inclusion and 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Free and Cued Selective Reminding Test (FCSRT) scale score | The FCSRT test evaluates memory, the score obtained is between 0 and 48, higher score mean a better outcome | From inclusion to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Free and Cued Selective Reminding Test (FCSRT) scale score | The FCSRT test evaluates memory, the score obtained is between 0 and 48, higher score mean a better outcome | From inclusion to 12 months |
| Cognitive decline in ADCS-PACC composite score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire Denis | Contact | +33467333162 | claire-denis@chu-montpellier.fr | |
| Yves Dauvilliers, MD | Contact | +33467335219 | y-dauvilliers@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Karim BENNYS, MD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Montpellier | Recruiting | Montpellier | France |
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| Neuropsychological assessment | Behavioral | A full neuropsychological assessment will be performed at inclusion, 12 and 24 months |
|
| Questionnaires on sleep and behavioural problems | Behavioral | Questionnaires on sleep and behavioural problems |
|
| Actimetry | Procedure | Measurement of actimetrics for 14 days at inclusion and at 24 months |
|
| Fractional diuresis | Diagnostic Test | Split diuresis from 7pm-7am, 7am-12am and 12pm-19pm during polysomnography at inclusion inclusion and 24 months to measure melatonin concentration |
|
| Internal temperature measurement | Procedure | eCelsius capsule to measure internal temperature at inclusion and 24 months |
|
| Biomarker assay | Other | Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid |
|
The ADCS-PACC composite score is used to assess cognitive decline |
| At inclusion and at 24 months |
| Cognitive decline in the Alzheimer's Disease Cooperative Study- Preclinical Alzheimer Cognitive Composite (ADCS-PACC) composite score | The ADCS-PACC composite score is used to assess cognitive decline | At inclusion and at 12 months |
| Concentration of proteins involved in Alzheimer disease | Determination of Aβ42, Aβ40, Tau and P-Tau proteins in serum and cerebrospinal fluid | At inclusion and at 24 months |
| Concentration of orexinA/hypocretin | Determination in serum and cerebrospinal fluid | At inclusion and at 24 months |
| Changes in sleep duration | Average sleep duration (in hours and minutes) over a 14-day period from inclusion to M24 measured by actimetry | At inclusion and at 24 months |
| Sleep time at stage 1-2 during polysomnography | Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography | At inclusion and at 24 months |
| Sleep time at stage 3 during polysomnography | Time spent in stage 3 sleep measured in hours and minutes during polysomnography | At inclusion and at 24 months |
| Time spent in Rapid eye movement (REM) sleep during polysomnography | Time spent in stage 3 sleep measured in hours and minutes during polysomnography | At inclusion and at 24 months |
| Apnea Hypopnea Index | The Apnea-Hypopnea Index is calculated from the number of apneas and hypopneas per hour of sleep (AHI = number of apneas + number of hypopneas / number of hours of sleep) during polysomnography | At inclusion and at 24 months |
| Nocturnal oxygen saturation (SaO2) | The nocturnal SaO2 is an average of SaO2 values taken during the night. The value is expressed as a percentage and is measured during polysomnography | At inclusion and at 24 months |
| Urinary melatonin concentration | Fractional diuresis | At inclusion and at 24 months |
| Internal temperature | The internal temperature will be measured with an e-Celsius capsule during polysomnography | At inclusion and at 24 months |
| University Hospital of Poitiers | Not yet recruiting | Poitiers | France |
|
| University Hospital of Toulouse | Not yet recruiting | Toulouse | France |
|
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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