Clinical trial NCT05629871: Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?
Official title: Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathology
Keywords: cognitive composite score
sleep
biomarkers
cognitive decline
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-11-29
Enrollment: 132
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild Alzheimer's disease with a Mini Mental State (MMS) between 21-30
* The presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries
* Having a neurological assessment and/or follow-up requiring blood and cerebrospinal fluid (CSF) sampling with biomarkers for diagnostic purposes
* Patient who had a lumbar puncture less than one year ago or patient with a scheduled lumbar puncture as part of care
* Signed informed consent
* Able to carry out all visits and follow study procedures
* Affiliation to the French social security system

Exclusion Criteria:

* Genetic form of alzheimer's disease
* Insufficient clinical and paraclinical information for the diagnosis of AD
* Anticholinesterase and/or memantine treatment or on stable doses for at least 3 months
* Use of antidepressants, anxiolytics, hypnotics, neuroleptics, 15 days before inclusion
* Patient living in a nursing home
* Illiteracy or inability to perform psycho-behavioural tests
* Major physical or neurosensory problems that may interfere with the tests
* Initial contraindication to diagnostic lumbar puncture (LP) (spinal surgery, skin infection, haemostasis abnormality, intracranial hypertension, severe coagulation disorders, curative anticoagulant therapy, severe liver failure)
* Refusal to perform a diagnostic lumbar puncture
* Contraindication to the use of E-Celsius: people weighing less than 40 kg, with intestinal disorders, with known swallowing disorders
* Patient deprived of liberty, by judicial or administrative decision;
* Major protected by law;
* Patient in a period of relative exclusion from another protocol or for whom the maximum annual compensation of €4500 has been reached;
* Refusal to participate in the protocol.

Primary outcomes:
measure: Change in the Free and Cued Selective Reminding Test (FCSRT) scale score
timeFrame: From inclusion to 24 months
Secondary outcomes:
measure: Change in the Free and Cued Selective Reminding Test (FCSRT) scale score
timeFrame: From inclusion to 12 months
measure: Cognitive decline in ADCS-PACC composite score
timeFrame: At inclusion and at 24 months
measure: Cognitive decline in the Alzheimer's Disease Cooperative Study- Preclinical Alzheimer Cognitive Composite (ADCS-PACC) composite score
timeFrame: At inclusion and at 12 months
measure: Concentration of proteins involved in Alzheimer disease
timeFrame: At inclusion and at 24 months
measure: Concentration of orexinA/hypocretin
timeFrame: At inclusion and at 24 months
measure: Changes in sleep duration
timeFrame: At inclusion and at 24 months
measure: Sleep time at stage 1-2 during polysomnography
timeFrame: At inclusion and at 24 months
measure: Sleep time at stage 3 during polysomnography
timeFrame: At inclusion and at 24 months
measure: Time spent in Rapid eye movement (REM) sleep during polysomnography
timeFrame: At inclusion and at 24 months
measure: Apnea Hypopnea Index
timeFrame: At inclusion and at 24 months
measure: Nocturnal oxygen saturation (SaO2)
timeFrame: At inclusion and at 24 months
measure: Urinary melatonin concentration
timeFrame: At inclusion and at 24 months
measure: Internal temperature
timeFrame: At inclusion and at 24 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital, Montpellier
city: Poitiers
country: France
facility: University Hospital of Poitiers
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital, Montpellier
name: Karim BENNYS, MD
role: PRINCIPAL_INVESTIGATOR
References: