Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT05977712
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2023-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Circadian Rhythm and Other Factors in Memory Clinic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2042-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2023-08-03', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dementia subtypes and stages (% at inclusion)', 'timeFrame': 'At inclusion', 'description': "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.\n\nThis 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.\n\nThis outcome will be examined as %"}, {'measure': 'Dementia subtypes and stages (incidence)', 'timeFrame': 'From inclusion until last routine visit at the memory clinic within the 15 years following inclusion', 'description': "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.\n\nThis 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.\n\nThis 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"}, {'measure': "Alzheimer's disease stages (%)", 'timeFrame': 'At inclusion', 'description': '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.\n\nThis analysis will be among those with CSF biomarkers measured as part of their routine visit at the memory clinics.'}, {'measure': "Alzheimer's disease stages (change in)", 'timeFrame': 'From inclusion until last routine visit at the memory clinic within the 15 years following inclusion', 'description': '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.\n\nThis analysis will be among those with CSF biomarkers measured as part of their routine visit at the memory clinics.\n\nThis outcome will be measured as part of the usual routine visits with the clinician (passive follow-up, visit not specific to CIRCAME)'}], 'secondaryOutcomes': [{'measure': 'Level of Amyloid β 42/40 ratio (concentration)', 'timeFrame': 'At inclusion', 'description': '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'}, {'measure': 'Level of neurofilament light (NfL) (concentration)', 'timeFrame': 'At inclusion', 'description': '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'}, {'measure': 'Level of Glial fibrillary acidic protein (GFAP) (concentration)', 'timeFrame': 'At inclusion', 'description': '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'}, {'measure': 'Level of phosphorylated tau (p-tau) (concentration)', 'timeFrame': 'At inclusion', 'description': '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'}, {'measure': 'Level of baseline cognition (mini-mental status examination)', 'timeFrame': 'At inclusion', 'description': 'At inclusion the mini-mental status examination will be assessed by trained nurse and with possible scores between 0 and 30'}, {'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', 'description': 'The mini-mental status examination will be extracted from memory clinic records from routine visits with the clinician at memory clinics'}, {'measure': 'Level of baseline cognition (MemScreen)', 'timeFrame': 'At inclusion', 'description': 'At inclusion the MemScreen digital cognitive test will be assessed by trained nurse and with possible scores between 0 and 34'}, {'measure': 'Change in cognitive performance (MemScreen)', 'timeFrame': 'From inclusion until last routine visit at the memory clinic within the 15 years following inclusion', 'description': 'The MemScreen will be extracted from memory clinic records from routine visits with the clinician at memory clinics'}, {'measure': 'Level of limitations in basic activities of daily living', 'timeFrame': 'At inclusion', 'description': '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'}, {'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', 'description': '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'}, {'measure': 'Level of limitations in instrumental activities of daily living', 'timeFrame': 'At inclusion', 'description': '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'}, {'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', 'description': '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.'}, {'measure': 'Incidence of institutionalization', 'timeFrame': 'From inclusion until last routine visit at the memory clinic within the 15 years following inclusion', 'description': 'Information on entrance in institution (medical institution for long stay) will come from memory clinics records.'}, {'measure': 'Incidence of hospitalisation', 'timeFrame': 'From inclusion until last routine visit at the memory clinic within the 15 years following inclusion', 'description': 'Information on entrance in hospitalisation (planned or unplanned) will come from memory clinics records.'}, {'measure': 'Incidence of death', 'timeFrame': 'From inclusion until last routine visit at the memory clinic within the 15 years following inclusion', 'description': 'Information on death (date) will come from memory clinics records.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThis 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1500 patients selected from two memory clinics in Paris (Lariboisière - F. Widal and Bretonneau).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient of legal age (18 or over)\n* Signed informed consent form\n* Patient affiliated to the french social security system\n\nExclusion Criteria:\n\n* Skin allergy to plastic\n* Diagnosis of psychiatric disorder that can explain all cognitive symptoms\n* 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)\n* 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'}, 'identificationModule': {'nctId': 'NCT05977712', 'acronym': 'CIRCAME', 'briefTitle': 'Circadian Rhythm and Other Factors in Memory Clinic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Circadian Rhythm and Other Individual Factors Among Memory Clinic Patients', 'orgStudyIdInfo': {'id': 'APHP230740'}, 'secondaryIdInfos': [{'id': '2023-A01469-36', 'type': 'OTHER', 'domain': 'ID-RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'CIRCAME', 'description': 'This is the full cohort of patients that compose the CIRCAME study (N estimated = 1500)', 'interventionNames': ['Other: Questionnaire', 'Other: Clinical examination', 'Other: Accelerometer port']}, {'label': 'CIRCAME-EYE ancillary study', 'description': '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)', 'interventionNames': ['Other: Eye examination']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['CIRCAME']}, {'name': 'Clinical examination', 'type': 'OTHER', 'description': "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).", 'armGroupLabels': ['CIRCAME']}, {'name': 'Accelerometer port', 'type': 'OTHER', 'description': 'Participants will be wearing an accelerometer for 9 days.', 'armGroupLabels': ['CIRCAME']}, {'name': 'Eye examination', 'type': 'OTHER', 'description': 'Eye fundus photo, OCT and OCT-A exams', 'armGroupLabels': ['CIRCAME-EYE ancillary study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire PAQUET, MDPhD', 'role': 'CONTACT', 'email': 'claire.paquet@aphp.fr', 'phone': '0140054313', 'phoneExt': '33'}], 'facility': 'Centre de neurologie Cognitive / CMRR', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie LACAILLE, MDPhD', 'role': 'CONTACT', 'email': 'sophie.lacaille@aphp.fr', 'phone': '0153111701', 'phoneExt': '33'}], 'facility': 'Hôpital de Jour Gériatrique et consultation mémoire', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Claire PAQUET, MDPhD', 'role': 'CONTACT', 'email': 'claire.paquet@aphp.fr', 'phone': '0140054313', 'phoneExt': '33'}, {'name': 'Séverine SABIA, PhD', 'role': 'CONTACT', 'email': 'severine.sabia@inserm.fr', 'phone': '0157279046', 'phoneExt': '33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'Fondation Rothschild Paris', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}