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

NCT05649514 | Recruiting

• 1 other identifier: RECHMPL22_0392
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Neuropathology; Cognitive Decline; Sleep Disorder

Keywords

cognitive composite score; sleep; biomarkers; cognitive decline

Outcome Measures

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

  From inclusion to 24 months

Secondary Outcomes (8)

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

  From inclusion to 12 months

• Cognitive decline in ADCS-PACC composite score

  At inclusion and at 12 months

• Concentration of proteins involved in Alzheimer disease

  At inclusion and at 24 months

• Sleep time at stage 1-2 during polysomnography

  At inclusion and at 24 months

• Sleep time at stage 3 during polysomnography

  At inclusion and at 24 months

Study Arms (1)

Single arm

EXPERIMENTAL

Prodromal Alzheimer's patients

Procedure: Polysomnography; Behavioral: Neuropsychological assessment; Behavioral: Questionnaires on sleep and behavioural problems; Procedure: Actimetrics; Other: Biomarker assay

Interventions

Polysomnography PROCEDURE

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

Single arm

Neuropsychological assessment BEHAVIORAL

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

Single arm

Questionnaires on sleep and behavioural problems BEHAVIORAL

Questionnaires on sleep and behavioural problems

Single arm

Actimetrics PROCEDURE

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

Single arm

Biomarker assay OTHER

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

Single arm

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed informed consent
• Able to carry out all visits and follow study procedures
• Affiliation to the French social security system

You may not qualify if:

• 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
• Major physical or neurosensory problems that may interfere with the tests
• Patient deprived of liberty, by judicial or administrative decision;
• Major depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
• Major protected by law;
• Short-term life-threatening conditions

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

CHU de Montpellier

Montpellier, Hérault, 34000, France

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Sleep Wake Disorders

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Karim BENNYS, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves Dauvilliers, MD

CONTACT

+33467335219; y-dauvilliers@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 14, 2022
• Study Start: February 5, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)