Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?

University Hospital, Montpellier3 sites in 1 country132 target enrollmentApril 17, 2023

ConditionsNeuropathology

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neuropathology
Sponsor: University Hospital, Montpellier
Enrollment: 132
Locations: 3
Primary Endpoint: Change in the Free and Cued Selective Reminding Test (FCSRT) scale score
Status: Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 17, 2023

End Date

July 1, 2027

Last Updated

6 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Montpellier

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Change in the Free and Cued Selective Reminding Test (FCSRT) scale score

Time Frame: From inclusion to 24 months

The FCSRT test evaluates memory, the score obtained is between 0 and 48, higher score mean a better outcome

Secondary Outcomes

Cognitive decline in ADCS-PACC composite score(At inclusion and at 24 months)
Change in the Free and Cued Selective Reminding Test (FCSRT) scale score(From inclusion to 12 months)
Concentration of proteins involved in Alzheimer disease(At inclusion and at 24 months)
Concentration of orexinA/hypocretin(At inclusion and at 24 months)
Sleep time at stage 3 during polysomnography(At inclusion and at 24 months)
Time spent in Rapid eye movement (REM) sleep during polysomnography(At inclusion and at 24 months)
Changes in sleep duration(At inclusion and at 24 months)
Urinary melatonin concentration(At inclusion and at 24 months)
Cognitive decline in the Alzheimer's Disease Cooperative Study- Preclinical Alzheimer Cognitive Composite (ADCS-PACC) composite score(At inclusion and at 12 months)
Sleep time at stage 1-2 during polysomnography(At inclusion and at 24 months)
Apnea Hypopnea Index(At inclusion and at 24 months)
Nocturnal oxygen saturation (SaO2)(At inclusion and at 24 months)
Internal temperature(At inclusion and at 24 months)