Trials / Recruiting
RecruitingNCT05629871
Biomarkers of Sleep-wake Cycle in Prodromal Alzheimer's Disease: Role in Cognitive Decline?
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- Sponsor
- University Hospital, Montpellier · Academic / Other
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Polysomnography | Polysomnography will be performed for 24 hours at inclusion and 24 months |
| BEHAVIORAL | Neuropsychological assessment | A full neuropsychological assessment will be performed at inclusion, 12 and 24 months |
| BEHAVIORAL | Questionnaires on sleep and behavioural problems | Questionnaires on sleep and behavioural problems |
| PROCEDURE | Actimetry | Measurement of actimetrics for 14 days at inclusion and at 24 months |
| DIAGNOSTIC_TEST | Fractional diuresis | Split diuresis from 7pm-7am, 7am-12am and 12pm-19pm during polysomnography at inclusion inclusion and 24 months to measure melatonin concentration |
| PROCEDURE | Internal temperature measurement | eCelsius capsule to measure internal temperature at inclusion and 24 months |
| OTHER | Biomarker assay | Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid |
Timeline
- Start date
- 2023-04-17
- Primary completion
- 2027-07-01
- Completion
- 2027-07-01
- First posted
- 2022-11-29
- Last updated
- 2025-10-07
Locations
3 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05629871. Inclusion in this directory is not an endorsement.