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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the connection between sleep problems and memory decline in people who may be at risk of developing Alzheimer's disease (AD). Researchers want to see if worsening sleep is linked to the buildup of certain substances in the brain that are associated with Alzheimer's. If they find a connection, it could help doctors treat sleep issues earlier, possibly slowing down the progression of Alzheimer's.

To join this study, participants need to be diagnosed with mild Alzheimer's disease and have a specific range of cognitive function scores. They should not be taking certain medications for at least three months and need to have a family member or caregiver who can help with questionnaires and sleep logs. The trial is open to both men and women aged 18 to 85, and participants will need to be able to attend all study visits and procedures. It’s important to know that certain conditions, like living in a nursing home or having major depression, would exclude someone from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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