RecruitingNot ApplicableNCT05629871

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


Sponsor

University Hospital, Montpellier

Enrollment

132 participants

Start Date

Apr 17, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how sleep disturbances relate to the progression of early Alzheimer's disease. Researchers will measure sleep-wake cycle biomarkers (from blood, spinal fluid, and body temperature) alongside cognitive tests to see whether disrupted sleep predicts faster cognitive decline and whether it could serve as an early warning sign. **You may be eligible if...** - You have been diagnosed with mild Alzheimer's disease (MMSE score 21–30) - You have a family caregiver who can help with questionnaires and diaries - You have already had, or are scheduled for, a lumbar puncture (spinal fluid test) as part of your standard care - You are covered by the French social security system **You may NOT be eligible if...** - You have a genetic (hereditary) form of Alzheimer's disease - You have recently started or changed Alzheimer's medications (unless stable for at least 3 months) - You are taking antidepressants, sleep medications, or antipsychotics - You live in a nursing home - You have medical reasons that prevent a spinal fluid test (such as a clotting disorder, skin infection at the puncture site, or spinal surgery) - You have severe physical or sensory problems that interfere with testing Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPolysomnography

Polysomnography will be performed for 24 hours at inclusion and 24 months

BEHAVIORALNeuropsychological assessment

A full neuropsychological assessment will be performed at inclusion, 12 and 24 months

BEHAVIORALQuestionnaires on sleep and behavioural problems

Questionnaires on sleep and behavioural problems

PROCEDUREActimetry

Measurement of actimetrics for 14 days at inclusion and at 24 months

DIAGNOSTIC_TESTFractional diuresis

Split diuresis from 7pm-7am, 7am-12am and 12pm-19pm during polysomnography at inclusion inclusion and 24 months to measure melatonin concentration

PROCEDUREInternal temperature measurement

eCelsius capsule to measure internal temperature at inclusion and 24 months

OTHERBiomarker assay

Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid


Locations(3)

University Hospital, Montpellier

Montpellier, France

University Hospital of Poitiers

Poitiers, France

University Hospital of Toulouse

Toulouse, France

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NCT05629871


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