Health TrialsbyHealthPanel

Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease

ConditionsNeuropathologyCognitive DeclineSleep Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorUniversity Hospital, Montpellier

About this trial

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.

Treatment protocols in the field of Alzheimer's disease (AD) are directed towards participants at risk of developing the disease, such as those who carry at least one ε4 allele on apolipoprotein E (APOE ε4). An individual with 2 ε4 copies has a 30-55% risk of developing AD with an age of onset around 68 years and a dose effect of the allele on risk and age of onset of symptoms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of mild Alzheimer's disease with a MMS between 21-30

Without anticholinesterase and/or memantine treatment or on stable doses for at least 3 months

No antidepressant or anxiolytic treatment or stopped for at least 15 days

The presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries

Disqualifiers

Genetic form of alzheimer's disease

Insufficient clinical and paraclinical information for the diagnosis of AD

Patient living in a nursing home

Illiteracy or inability to perform psycho-behavioural tests

Trial design

Design model

Single group

Treatments tested in this trial

  • Polysomnography

    Procedure/Surgery

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

  • 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

  • Actimetrics

    Procedure/Surgery

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

  • Biomarker assay

    Other intervention

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Single armExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score

The ADCS-PACC scale will be based on scores from the Mini Mental State Examination (MMSE), the Free Recall/Indicated Recall Test, the Digit Substitution Symbol Test, the Wechsler Intelligence Scale for Adults (WAIS-IV), and the 2-minute Verbal Fluency Test

Time frame
From inclusion to 24 months

Secondary outcomes

1

Change in the Alzheimer's Disease Cooperative Study - Preclinical Alzheimer Cognitive (ADCS-PACC) scale score

The ADCS-PACC scale will be based on scores from the Mini Mental State Examination (MMSE), the Free Recall/Indicated Recall Test, the Digit Substitution Symbol Test, the Wechsler Intelligence Scale for Adults (WAIS-IV), and the 2-minute Verbal Fluency Test

Time frame
From inclusion to 12 months
2

Cognitive decline in ADCS-PACC composite score

The ADCS-PACC composite score is used to assess cognitive decline

Time frame
At inclusion and at 12 months
3

Concentration of proteins involved in Alzheimer disease

Determination of Aβ42, Aβ40, Tau and P-Tau proteins in serum and cerebrospinal fluid

Time frame
At inclusion and at 24 months
4

Sleep time at stage 1-2 during polysomnography

Time spent in stage 1-2 sleep measured in hours and minutes during polysomnography

Time frame
At inclusion and at 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator

Source ClinicalTrials.gov
Apply now