Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05977712 En recrutement IDF

Titre

Circadian Rhythm and Other Individual Factors Among Memory Clinic Patients (CIRCAME)

Type

Observational

Pathologie

Démence

Phase

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

mars 2024

Date de fin

mars 2042

Dernière mise à jour

05 avril 2025

Résumé

The CIRCAME study is a bicentric study of patients from 2 memory clinics in Paris. The main objective is to identify circadian rhythm components and other individual risk factors (sociodemographic, behavioral, and health related factors) associated with the diagnosis of subtypes (AD, Lewy bodies, vascular, frontotemporal dementia) and stages (cognitively healthy, mild cognitive impairment, clinical dementia) of dementia, independent of known risk factors (sociodemographic and genetic) and assess the relevance of use of these factors in primary care for screen of dementia including subtypes and stages. A secondary objective is to determine factors associated with progression of the disease, in terms of cognitive decline and limitations in activities of daily living, as well as progression to dementia among cognitively healthy controls and patients with mild cognitive impairment, up to 15 years after the inclusion period.

Détail

Voir le détail The diagnosis of Alzheimer's disease and other related dementias is mainly based on assessment of cognitive, behavioral and neuropsychological symptoms, functional limitations and imaging data/cerebrospinal fluid (CSF) biomarkers in some cases. These measures are primarily used in specialized clinics leading to a potential large number of dementia cases not being diagnosed. With population ageing, the number of people living with dementia is increasing and there is an urgent need for cost-effective, scalable tool for early, accurate screening of dementia cases, including both AD and other types of dementia, in primary care. Furthermore, the factors associated with the progression of the different types of dementia are still poorly understood, limiting the prospects for intervention to improve the quality of life of patients and their caregivers and to slow the progression of the disease. This project aims to identify circadian rhythm components and other individual risk factors that could be used in primary care for dementia diagnosis (including its subtypes: AD, Lewy bodies, vascular, frontotemporal dementia) and stages (cognitively healthy, mild cognitive impairment, clinical dementia). A secondary objective is to determine factors associated with progression of the disease, in terms of cognitive decline and limitations in activities of daily living, as well as progression to dementia among cognitively healthy controls and patients with mild cognitive impairment. This will be achieved using data from 1500 patients from 2 memory clinics in Paris from who data on sociodemographic, behavioral, and health related factors (such as reported sleep disturbance, plasma biomarkers, retina measures (in a subsample, CIRCAME-EYE)) will be measured at inclusion interview. Baseline examination will also include a wrist-mounted device for a measure of circadian rhythm and its related behaviors (physical activity and sleep), for which disruptions are thought to characterize dementia subtypes and stages. Information on dementia diagnosis and stages will come from memory clinic routine visits at the time of the inclusion; they will include subtypes (AD, Lewy bodies, vascular, frontotemporal dementia), cognitive stages (cognitively healthy, mild cognitive impairment, clinical dementia) and AD stages based on CSF biomarkers and clinical measures. Information on progression of the disease (change in cognitive function using the mini-mental status examination, change in limitations in activity of daily living) and incidence of dementia, institutionalization and mortality will be retrieved from patients' routine visits at memory clinics up to 15 years after the inclusion period. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
AP-HP - Hôpital Bretonneau	PAQUET Claire	En recrutement IDF	18/04/2025 07:56:04	Contacter
AP-HP - Hôpital Lariboisiere-Fernand Widal	PAQUET Claire	En recrutement IDF	18/04/2025 07:56:04	Contacter
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre de neurologie Cognitive / CMRR - 75010 - Paris - France	Claire PAQUET, MDPhD	En recrutement		Contact (sur clinicalTrials)
Hôpital de Jour Gériatrique et consultation mémoire - 75018 - Paris - France	Sophie LACAILLE, MDPhD	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- Patient of legal age (18 or over)

- Signed informed consent form

- Patient affiliated to the french social security system

Critère de non inclusion

- Skin allergy to plastic

- Diagnosis of psychiatric disorder that can explain all cognitive symptoms

- Inability to come accompanied for patients with a Mini-Mental State Examination
(MMSE) cognitive score ≤18 or a clinician assessment indicating the need to be
accompanied (e.g. wheelchair use, agitation)

- Participation at the time of inclusion and during the 9-day period of wearing the
accelerometer in interventional research with potential impact on circadian rhythm

NCT05977712 - Circadian Rhythm and Other Individual Factors Among Memory Clinic Patients (CIRCAME)

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Etablissements
Critères
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