Clinical trial NCT04044495: Sleep, Rhythms and Risk of Alzheimer's Disease
Official title: "Sleep, Rhythms and Risk of Alzheimer's Disease: a Daily Life Actigraphic Assessment and MRI Study" "SoRyMA - AMImage3"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Sleep
Keywords: Aging
Sleep/wake Cycle
Hippocampal connectivity
Hippocampal dependant Memory tests
Actigraphy
Functional and structural MRI
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 47
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Alterations in sleep and the sleep / wake cycle, which are particularly common in Alzheimer's disease patients, could represent an early biomarker for cognitive decline and onset of dementia . Moreover, these disturbances in activity rhythms and sleep patterns represent modifiable factors and therefore potential targets for the prevention of certain neurodegenerative disorders.

The main objective of this study will be to test the hypothesis that elderly people without major cognitive impairment who have circadian rhythm disorders of the sleep / wake cycle have structural and / or functional abnormalities in the central nervous system and more specifically of the hippocampal function which could represent a risk factor for the occurrence of cognitive impairment. Indeed, although many studies in both humans and animals suggest the existence of links between sleep alterations and age-related cognitive impairment, the causality of these observations is still not clear.

This description of the anatomical and functional substratum of sleep / wake cycle alterations occurring in an elderly population will be based on joint analysis of multimodal brain imaging (MRI) and neuropsychology actimetry data. The SoRyMA-AMImage 3 protocol will correspond to the 2nd actimetry measurement point and the 3rd MRI measurement point of a larger population-based cohort AMImage.

This project will collect data from the sleep / wake cycle (actimetry) from a sample of 100 patients included in AMI / AMImage 2 and relate them to brain imaging data (MRI). The main objective of the protocol is the evaluation of the link between changes in sleep and cycle parameters during aging and hippocampal functioning (through fMRI and neuropsychological score of hippocampal dependant tasks). The actimetry variables measured at the two follow-up (4 years apart) will make it possible to measure the degradation of the sleep and cycle parameters (through the reduction of sleep duration, sleep time, increase in sleep fragmentation and decrease in the relative amplitude of the rhythm).

This framework will provide access to a very large amount of data that can be cross-referenced with actimetry data; the longitudinal character of this data collected over a decade will also make it possible to work on the evolution of the actimetry parameters and its relationship with the cognitive and clinical evolution of the subjects. Thus, these data will make it possible to study the prognostic value of the analyzed actimetry parameters in association with very complete clinical and neuropsychological data.


Eligibility criteria: Inclusion Criteria:

* Belonging to AMImage 2 cohort and preferentially belonging to subjects included in the first actimetric assessment. AMI subjects have been selected based on Mutualité Sociale Agricole of Gironde (agricultural Health Insurance system database as followed :

  * \>65 years old
  * Retired from agriculture
  * Living in Gironde countryside
  * Being affiliated to the French Farmers Health Insurance
* Signed Informed Consent

Exclusion Criteria:

* Left Handed subjects
* Severe dementia (MMSE\<13)
* Stroke
* Parkinson's disease
* MRI contraindication
* Health state not allowing displacement to the hospital
* Person under gardianship and not able to give its informed consent

Primary outcomes:
measure: Bold Signal
timeFrame: Day 1
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: Day 1
measure: Mannheim Dream questionnaire (MADRE)
timeFrame: Day 1
measure: Epworth Sleepiness Scale
timeFrame: Day 1
measure: Toronto Alexithymia Scale (TAS-20)
timeFrame: Day 1
measure: Positive and Negative Affective Scale (PANAS)
timeFrame: Day 1
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Day 1
measure: Actimetry
timeFrame: Up to 7 days
measure: Sleep diary
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Henri de CLERMONT-GALLERANDE
role: PRINCIPAL_INVESTIGATOR
References: