Objective Sleep Impairment in APOEε4/ε4 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Montpellier
RECRUITING
Montpellier
Contact Information
Primary
Yves Dauvilliers, MD
y-dauvilliers@chu-montpellier.fr
+33467335219
Time Frame
Start Date: 2025-02-05
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 50
Treatments
Experimental: Single arm
Prodromal Alzheimer's patients
Related Therapeutic Areas
Sponsors
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov