Circadian Rhythm and Other Factors in Memory Clinic Patients

NCT ID: NCT05977712

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-06
• Study Completion Date: 2042-03-31

Brief Summary

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.

Detailed Description

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) and audiological parameters (CIRCAME-Ear substudy)) 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.

Conditions

Dementia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CIRCAME

This is the full cohort of patients that compose the CIRCAME study (N estimated = 1500)

Questionnaire

Intervention Type: OTHER

The questionnaire includes information on socio-demographics (age, sex, education, occupation, marital status), behavioural (smoking, alcohol consumption, social functioning), and health-related factors (morbidities, treatment, sleep disturbance, eye diseases, frailty, falls).

Clinical examination

Intervention Type: OTHER

This includes earing test, cognitive tests (mini-mental status examination, MemScreen), body mass index, waist circumference, blood pressure and blood tests (biomarkers of Alzheimer's disease, neurodegeneration, and other dementias).

Accelerometer port

Intervention Type: OTHER

Participants will be wearing an accelerometer for 9 days.

CIRCAME-EYE ancillary study

Patients from CIRCAME seen at the Fernand-Widal hospital who will also undergo an eye examination (CIRCAME-EYE, N estimated = 1100, a sub-group of CIRCAME)

Eye examination

Intervention Type: OTHER

Eye fundus photo, OCT and OCT-A exams

CIRCAME-EAR ancillary study

Patients from CIRCAME seen at the Fernand-Widal hospital who will also undergo an audiolological examination (CIRCAME-EAR, N estimated = 1100, a sub-group of CIRCAME)

Ear Examination

Intervention Type: OTHER

Otoscopic examination, Wideband tympanometry, Pure-tone and speech audiometry (in quiet and in noise), Auditory evoked potentials, Electroencephalogram with auditory stimulation

Interventions

Questionnaire

The questionnaire includes information on socio-demographics (age, sex, education, occupation, marital status), behavioural (smoking, alcohol consumption, social functioning), and health-related factors (morbidities, treatment, sleep disturbance, eye diseases, frailty, falls).

Intervention Type: OTHER

Clinical examination

This includes earing test, cognitive tests (mini-mental status examination, MemScreen), body mass index, waist circumference, blood pressure and blood tests (biomarkers of Alzheimer's disease, neurodegeneration, and other dementias).

Intervention Type: OTHER

Accelerometer port

Participants will be wearing an accelerometer for 9 days.

Intervention Type: OTHER

Eye examination

Eye fundus photo, OCT and OCT-A exams

Intervention Type: OTHER

Ear Examination

Otoscopic examination, Wideband tympanometry, Pure-tone and speech audiometry (in quiet and in noise), Auditory evoked potentials, Electroencephalogram with auditory stimulation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient of legal age (18 or over)
• Signed informed consent form
• Patient affiliated to the french social security system

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Fondation Rothschild Paris

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre de neurologie Cognitive / CMRR

Paris, France, France

Site Status: RECRUITING

Hôpital de Jour Gériatrique et consultation mémoire

Paris, France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Claire PAQUET, MDPhD

Role: CONTACT

claire.paquet@aphp.fr

0140054313 ext. 33

Séverine SABIA, PhD

Role: CONTACT

severine.sabia@inserm.fr

0157279046 ext. 33

Facility Contacts

Claire PAQUET, MDPhD

Role: primary

claire.paquet@aphp.fr

0140054313 ext. 33

Sophie LACAILLE, MDPhD

Role: primary

sophie.lacaille@aphp.fr

0153111701 ext. 33

Other Identifiers

2023-A01469-36

Identifier Type: OTHER

Identifier Source: secondary_id

APHP230740

Identifier Type: -

Identifier Source: org_study_id