An observational study in Dementia, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 256 across 553 observational studies indexed under Dementia.
Browse Dementia studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
1500 patients selected from two memory clinics in Paris (Lariboisière - F. Widal and Bretonneau).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is the full cohort of patients that compose the CIRCAME study (N estimated = 1500)
Other: Questionnaire · Other: Clinical examination · Other: Accelerometer port
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)
Other: Eye examination
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)
Other: Ear Examination
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).
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).
Participants will be wearing an accelerometer for 9 days.
Eye fundus photo, OCT and OCT-A exams
Otoscopic examination, Wideband tympanometry, Pure-tone and speech audiometry (in quiet and in noise), Auditory evoked potentials, Electroencephalogram with auditory stimulation
Dementia subtypes and stages (% at inclusion)
Dementia subtypes and stages will be defined at inclusion based on the most recent routine visits at the memory center and categorised as: Alzheimer's disease, vascular dementia, Lewy body dementia, frontotemporal dementia), as having MCI (differentiating AD form of MCI and others), or being cognitively healthy. This consensus diagnosis of dementia subtypes among clinicians from the memory clinics is based on clinical examination consisting of a large battery of cognitive tests, assessment of behavioural and neuropsychological symptoms, and limitations in basic and instrumental activities of daily living (ADL/IADL), and additional examination of magnetic resonance imaging (MRI) and CSF biomarkers when AD is suspected or clinical symptoms do not provide an unequivocal diagnosis. This outcome will be examined as %
Time frame: At inclusion
Dementia subtypes and stages (incidence)
Dementia subtypes and stages will be defined on routine visits at the memory clini and categorised as: Alzheimer's disease, vascular dementia, Lewy body dementia, frontotemporal dementia), as having MCI (differentiating AD form of MCI and others), or being cognitively healthy. This consensus diagnosis of dementia subtypes among clinicians from the memory clinics is based on clinical examination consisting of a large battery of cognitive tests, assessment of behavioural and neuropsychological symptoms, and limitations in basic and instrumental activities of daily living (ADL/IADL), and additional examination of magnetic resonance imaging (MRI) and CSF biomarkers when AD is suspected or clinical symptoms do not provide an unequivocal diagnosis. This outcome will be examined among those with MCI and healthy controls as incident cases over time (up to 15 years after the inclusion) This outcome will be measured as part of the usual routine visits with the clinician (passive follow-up, vis
Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Alzheimer's disease stages (%)
AD stages will be based on the most recent measure of CSF Aβ peptide level (Aβ42/40 ratio) to assess the A+ criterion, p-Tau 181 to assess the T+ criterion, and clinical examination to assess the CogFI+ criterion (cognitive impairment and/or neurobehavioural symptoms with functional impact on daily life). Patients will be categorised based on all combinations of positivity status on A, T and CogFI and % in each category will be compared. This analysis will be among those with CSF biomarkers measured as part of their routine visit at the memory clinics.
Time frame: At inclusion
Alzheimer's disease stages (change in)
AD stages change will be based on the most recent measure of CSF Aβ peptide level (Aβ42/40 ratio) to assess the A+ criterion, p-Tau 181 to assess the T+ criterion, and clinical examination to assess the CogFI+ criterion (cognitive impairment and/or neurobehavioural symptoms with functional impact on daily life). Patients will be categorised based on all combinations of positivity status on A, T and CogFI and change in categories since inclusion status will be compared. This analysis will be among those with CSF biomarkers measured as part of their routine visit at the memory clinics. This outcome will be measured as part of the usual routine visits with the clinician (passive follow-up, visit not specific to CIRCAME)
Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Level of Amyloid β 42/40 ratio (concentration)
Amyloid β 42/40 ratio, a marker of AD pathology, will be measured based on Simoa 4-plex E assay of plasma sample from the inclusion visit
Time frame: At inclusion
Level of neurofilament light (NfL) (concentration)
Neurofilament light (NfL), a marker of neurodegeneration in all neurodegenerative diseases, will be measured based on Simoa 4-plex E assay of plasma sample from the inclusion visit
Time frame: At inclusion
Level of Glial fibrillary acidic protein (GFAP) (concentration)
Glial fibrillary acidic protein (GFAP), a marker of astrocytosis, will be measured based on Simoa 4-plex E assay of plasma sample from the inclusion visit
Time frame: At inclusion
Level of phosphorylated tau (p-tau) (concentration)
Phosphorylated tau (p-tau) for detection of early AD-related tauopathy and disease staging ,will be measured based on ALZ-path Simoa p-tau 217 assay of plasma sample from the inclusion visit
Time frame: At inclusion
Level of baseline cognition (mini-mental status examination)
At inclusion the mini-mental status examination will be assessed by trained nurse and with possible scores between 0 and 30
Time frame: At inclusion
Change in cognitive performance (mini-mental status examination)
The mini-mental status examination will be extracted from memory clinic records from routine visits with the clinician at memory clinics
Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Level of baseline cognition (MemScreen)
At inclusion the MemScreen digital cognitive test will be assessed by trained nurse and with possible scores between 0 and 34
Time frame: At inclusion
Change in cognitive performance (MemScreen)
The MemScreen will be extracted from memory clinic records from routine visits with the clinician at memory clinics
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
At inclusion the number of limitations in activities of daily living ((dressing, walking, bathing, eating, continence, using toilet) will be assessed by trained nurse and with possible scores between 0 and 6
Time frame: At inclusion
Change in limitations in basic activities of daily living
Change since inception in the number of limitations in activities of daily living (dressing, walking, bathing, eating, continence, using toilet) will be examined. The number of limitations in activities of daily living will be extracted from memory clinic records from routine visits with the clinician at memory clinics
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
At inclusion the number of limitations in activities of daily living (cooking, shopping for grocery, telephone calls, taking medication, using transports, managing money) will be assessed by trained nurse and with possible scores between 0 and 6
Time frame: At inclusion
Change in limitations in instrumental activities of daily living
Change since inception in the number of limitations in instrumental activities of daily living (cooking, shopping for grocery, telephone calls, taking medication, using transports, managing money) will be examined. The number of limitations in instrumental activities of daily living will be extracted from memory clinic records from routine visits with the clinician at memory clinics.
Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Incidence of institutionalization
Information on entrance in institution (medical institution for long stay) will come from memory clinics records.
Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Incidence of hospitalisation
Information on entrance in hospitalisation (planned or unplanned) will come from memory clinics records.
Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Incidence of death
Information on death (date) will come from memory clinics records.
Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Mar 2027, 36 months after the start.
Of 271 non-industry observational studies under Dementia, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 202. This study's planned 36 months is below that.
Counting every sponsor, half of 293 studies reached it within 67 months; a quarter within 29 and three quarters within 188.
How these figures are worked out, and which studies are left out of them.
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