Circadian Rhythm and Other Factors in Memory Clinic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaire, Clinical examination, Accelerometer port, Eye examination.
- Who it may be relevant to
- Registry conditions: Dementia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Circadian Rhythm and Other Individual Factors Among Memory Clinic Patients
Overview
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.
Interventions
- Other 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). - 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). - Other Accelerometer port
Participants will be wearing an accelerometer for 9 days. - Other Eye examination
Eye fundus photo, OCT and OCT-A exams - Other Ear Examination
Otoscopic examination, Wideband tympanometry, Pure-tone and speech audiometry (in quiet and in noise), Auditory evoked potentials, Electroencephalogram with auditory stimulation
Primary outcome measures
- Dementia subtypes and stages (% at inclusion) [Time frame: At inclusion]
- Dementia subtypes and stages (incidence) [Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion]
- Alzheimer's disease stages (%) [Time frame: At inclusion]
- Alzheimer's disease stages (change in) [Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion]
Secondary outcome measures (12)
- Level of Amyloid β 42/40 ratio (concentration) [Time frame: At inclusion]
- Level of neurofilament light (NfL) (concentration) [Time frame: At inclusion]
- Level of Glial fibrillary acidic protein (GFAP) (concentration) [Time frame: At inclusion]
- Level of phosphorylated tau (p-tau) (concentration) [Time frame: At inclusion]
- Level of baseline cognition (mini-mental status examination) [Time frame: At inclusion]
- Change in cognitive performance (mini-mental status examination) [Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion]
- Level of baseline cognition (MemScreen) [Time frame: At inclusion]
- Change in cognitive performance (MemScreen) [Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion]
- Level of limitations in basic activities of daily living [Time frame: At inclusion]
- Change in limitations in basic activities of daily living [Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion]
- Level of limitations in instrumental activities of daily living [Time frame: At inclusion]
- Change in limitations in instrumental activities of daily living [Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Centre de neurologie Cognitive / CMRR — Paris
- Hôpital de Jour Gériatrique et consultation mémoire — Paris
Identifiers
NCT: NCT05977712 · APHP230740 · 2023-A01469-36