DementiaCIRCAMENCT05977712
Circadian Rhythm and Other Factors in Memory Clinic Patients
An observational study of Dementia, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Questionnaire, Clinical examination and Accelerometer port
- How many people
- 1,200 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Mar 2024to Mar 2042
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1500 patients selected from two memory clinics in Paris (Lariboisière - F. Widal and Bretonneau).
Who may be able to join
- Patient of legal age (18 or over)
- Signed informed consent form
- Patient affiliated to the french social security system
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre de neurologie Cognitive / CMRR
Paris, France, 75010
Claire PAQUET, MDPhD, 0140054313 ext. 33, claire.paquet@aphp.fr
- Recruiting
Hôpital de Jour Gériatrique et consultation mémoire
Paris, France, 75018
Sophie LACAILLE, MDPhD, 0153111701 ext. 33, sophie.lacaille@aphp.fr
About this study
Official title: Circadian Rhythm and Other Individual Factors Among Memory Clinic Patients
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.
Read the 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
- Being tested
- Questionnaire, Clinical examination, Accelerometer port, Eye examination, Ear Examination
- 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, audiological function
- Medical subject headings
- Dementia, Parasomnias, Disease Progression, Alzheimer Disease, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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 examinationOther
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 portOther
Participants will be wearing an accelerometer for 9 days.
Eye examinationOther
Eye fundus photo, OCT and OCT-A exams
Ear ExaminationOther
Otoscopic examination, Wideband tympanometry, Pure-tone and speech audiometry (in quiet and in noise), Auditory evoked potentials, Electroencephalogram with auditory stimulation
| Study group | Role | What they receive |
|---|---|---|
| CIRCAME | This is the full cohort of patients that compose the CIRCAME study (N estimated = 1500) Receives: Other: Questionnaire; Other: Clinical examination; Other: Accelerometer port | |
| 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) Receives: Other: Eye examination | |
| 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) Receives: Other: Ear Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %
Measured: 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
Measured: 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.
Measured: 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)
Measured: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start6 Mar 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Fondation Rothschild Paris
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977712
- Sponsor's protocol ID
- APHP230740
- Other IDs
- 2023-A01469-36
- Acronym
- CIRCAME
- Status last verified
- Feb 2026
- First submitted
- 28 Jul 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Rhythm and Other Individual Factors Among Memory Clinic Patients
- ClinicalTrials.gov ID
- NCT05977712
- Acronym / sponsor ID
- CIRCAME / APHP230740
- Conditions
- Dementia
- Keywords
- Circadian rhythm, Sleep disturbance, APOE, Retinal measures, Dementia subtypes, stages and progression, Alzheimer's disease, Lewy body dementia, Plasma biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Fondation Rothschild Paris
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2042 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CIRCAME | – | Other: Questionnaire, Other: Clinical examination, Other: Accelerometer portThis is the full cohort of patients that compose the CIRCAME study (N estimated = 1500) |
| CIRCAME-EYE ancillary study | – | Other: Eye examinationPatients 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) |
| CIRCAME-EAR ancillary study | – | Other: Ear ExaminationPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1500 patients selected from two memory clinics in Paris (Lariboisière - F. Widal and Bretonneau).
Key inclusion criteria (3 listed)
- Patient of legal age (18 or over)
- Signed informed consent form
- Patient affiliated to the french social security system
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireThe 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 | CIRCAME |
| Clinical examinationThis 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 | CIRCAME |
| Accelerometer portParticipants will be wearing an accelerometer for 9 days. | Other | CIRCAME |
| Eye examinationEye fundus photo, OCT and OCT-A exams | Other | CIRCAME-EYE ancillary study |
| Ear ExaminationOtoscopic examination, Wideband tympanometry, Pure-tone and speech audiometry (in quiet and in noise), Auditory evoked potentials, Electroencephalogram with auditory stimulation | Other | CIRCAME-EAR ancillary study |
Primary outcome
Dementia subtypes and stages (% at inclusion)
Time frame: 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 %
Dementia subtypes and stages (incidence)
Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
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
Alzheimer's disease stages (%)
Time frame: At inclusion
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.
Alzheimer's disease stages (change in)
Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
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)
15 secondary outcomes
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
Incidence of institutionalization
Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Incidence of hospitalisation
Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Incidence of death
Time frame: From inclusion until last routine visit at the memory clinic within the 15 years following inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Dementia
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Recruiting
Technology-Based Intervention Pilot Testing
Dementia, Elder Abuse
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingPhase 2/3
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Agitation Associated With Alzheimer's Disease Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire PAQUET, MDPhD (0140054313 ext. 33, claire.paquet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dementia subtypes and stages (% at inclusion) (time frame: At inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.