Image

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

Recruiting
50 - 85 years of age
Both
Phase N/A

Powered by AI

Overview

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

Inclusion Criteria:

  • Diagnosis of mild Alzheimer's disease with a Mini Mental State (MMS) between 21-30
  • The presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries
  • Having a neurological assessment and/or follow-up requiring blood and cerebrospinal fluid (CSF) sampling with biomarkers for diagnostic purposes
  • Patient who had a lumbar puncture less than one year ago or patient with a scheduled lumbar puncture as part of care
  • 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
  • Anticholinesterase and/or memantine treatment or on stable doses for at least 3 months
  • Use of antidepressants, anxiolytics, hypnotics, neuroleptics, 15 days before inclusion
  • 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
  • Initial contraindication to diagnostic lumbar puncture (LP) (spinal surgery, skin infection, haemostasis abnormality, intracranial hypertension, severe coagulation disorders, curative anticoagulant therapy, severe liver failure)
  • Refusal to perform a diagnostic lumbar puncture
  • Contraindication to the use of E-Celsius: people weighing less than 40 kg, with intestinal disorders, with known swallowing disorders
  • Patient deprived of liberty, by judicial or administrative decision;
  • Major protected by law;
  • Patient in a period of relative exclusion from another protocol or for whom the maximum annual compensation of €4500 has been reached;
  • Refusal to participate in the protocol.

Study details

Neuropathology

NCT05629871

University Hospital, Montpellier

26 May 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.