Clinical trial NCT05977712: Circadian Rhythm and Other Factors in Memory Clinic Patients
Official title: Circadian Rhythm and Other Individual Factors Among Memory Clinic Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia
Keywords: Circadian rhythm
Sleep disturbance
APOE
Retinal measures
Dementia subtypes, stages and progression
Alzheimer's disease
Lewy body dementia
Plasma biomarkers
Cerebrospinal fluid biomarkers
Individual risk factors
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Fondation Rothschild Paris
First posted: 2023-08-04
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1500 patients selected from two memory clinics in Paris (Lariboisière - F. Widal and Bretonneau).

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)) 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.

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

Primary outcomes:
measure: Dementia subtypes and stages (% at inclusion)
timeFrame: At inclusion
measure: Dementia subtypes and stages (incidence)
timeFrame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
measure: Alzheimer's disease stages (%)
timeFrame: At inclusion
measure: Alzheimer's disease stages (change in)
timeFrame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Secondary outcomes:
measure: Level of Amyloid β 42/40 ratio (concentration)
timeFrame: At inclusion
measure: Level of neurofilament light (NfL) (concentration)
timeFrame: At inclusion
measure: Level of Glial fibrillary acidic protein (GFAP) (concentration)
timeFrame: At inclusion
measure: Level of phosphorylated tau (p-tau) (concentration)
timeFrame: At inclusion
measure: Level of baseline cognition (mini-mental status examination)
timeFrame: At inclusion
measure: Change in cognitive performance (mini-mental status examination)
timeFrame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
measure: Level of baseline cognition (MemScreen)
timeFrame: At inclusion
measure: Change in cognitive performance (MemScreen)
timeFrame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
measure: Level of limitations in basic activities of daily living
timeFrame: At inclusion
measure: Change in limitations in basic activities of daily living
timeFrame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
measure: Level of limitations in instrumental activities of daily living
timeFrame: At inclusion
measure: Change in limitations in instrumental activities of daily living
timeFrame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
measure: Incidence of institutionalization
timeFrame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
measure: Incidence of hospitalisation
timeFrame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
measure: Incidence of death
timeFrame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre de neurologie Cognitive / CMRR
city: Paris
country: France
facility: Hôpital de Jour Gériatrique et consultation mémoire
Study officials:
References: