Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?
ALZ-OREX
1 other identifier
interventional
132
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2022
CompletedFirst Posted
Study publicly available on registry
November 29, 2022
CompletedStudy Start
First participant enrolled
April 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
October 7, 2025
September 1, 2025
4.2 years
October 28, 2022
October 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Free and Cued Selective Reminding Test (FCSRT) scale score
The FCSRT test evaluates memory, the score obtained is between 0 and 48, higher score mean a better outcome
From inclusion to 24 months
Secondary Outcomes (13)
Change in the Free and Cued Selective Reminding Test (FCSRT) scale score
From inclusion to 12 months
Cognitive decline in ADCS-PACC composite score
At inclusion and at 24 months
Cognitive decline in the Alzheimer's Disease Cooperative Study- Preclinical Alzheimer Cognitive Composite (ADCS-PACC) composite score
At inclusion and at 12 months
Concentration of proteins involved in Alzheimer disease
At inclusion and at 24 months
Concentration of orexinA/hypocretin
At inclusion and at 24 months
- +8 more secondary outcomes
Study Arms (1)
Single arm
EXPERIMENTALAlzheimer
Interventions
Polysomnography will be performed for 24 hours at inclusion and 24 months
A full neuropsychological assessment will be performed at inclusion, 12 and 24 months
Questionnaires on sleep and behavioural problems
Split diuresis from 7pm-7am, 7am-12am and 12pm-19pm during polysomnography at inclusion inclusion and 24 months to measure melatonin concentration
eCelsius capsule to measure internal temperature at inclusion and 24 months
Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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;
- Refusal to participate in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University Hospital, Montpellier
Montpellier, France
University Hospital of Poitiers
Poitiers, France
University Hospital of Toulouse
Toulouse, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karim BENNYS, MD
University Hospital, Montpellier
Central Study Contacts
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
October 28, 2022
First Posted
November 29, 2022
Study Start
April 17, 2023
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
October 7, 2025
Record last verified: 2025-09