Circadian Rhythm and Other Factors in Memory Clinic Patients

NCT05977712 | Recruiting

• 2 other identifiers: APHP2307402023-A01469-36
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

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.

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; audiological function

Outcome Measures

Primary Outcomes (4)

• 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 %

  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

  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.

  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)

  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)

  At inclusion

• Level of neurofilament light (NfL) (concentration)

  At inclusion

• Level of Glial fibrillary acidic protein (GFAP) (concentration)

  At inclusion

• Level of phosphorylated tau (p-tau) (concentration)

  At inclusion

• Level of baseline cognition (mini-mental status examination)

  At inclusion

Study Arms (3)

CIRCAME

This is the full cohort of patients that compose the CIRCAME study (N estimated = 1500)

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)

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)

Other: Ear Examination

Interventions

Questionnaire OTHER

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).

CIRCAME

Clinical examination OTHER

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).

CIRCAME

Accelerometer port OTHER

Participants will be wearing an accelerometer for 9 days.

CIRCAME

Eye examination OTHER

Eye fundus photo, OCT and OCT-A exams

CIRCAME-EYE ancillary study

Ear Examination OTHER

Otoscopic examination, Wideband tympanometry, Pure-tone and speech audiometry (in quiet and in noise), Auditory evoked potentials, Electroencephalogram with auditory stimulation

CIRCAME-EAR ancillary study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1500 patients selected from two memory clinics in Paris (Lariboisière - F. Widal and Bretonneau).

You may qualify if:

• Patient of legal age (18 or over)
• Signed informed consent form
• Patient affiliated to the french social security system

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondation Rothschild Paris: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (2)

Centre de neurologie Cognitive / CMRR

Paris, France, 75010, France

RECRUITING

Hôpital de Jour Gériatrique et consultation mémoire

Paris, France, 75018, France

RECRUITING

MeSH Terms

Conditions

Dementia; Parasomnias; Disease Progression; Alzheimer Disease; Lewy Body Disease

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Sleep Wake Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tauopathies; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Central Study Contacts

Claire PAQUET, MDPhD

CONTACT

0140054313; claire.paquet@aphp.fr

Séverine SABIA, PhD

CONTACT

0157279046; severine.sabia@inserm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: March 6, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2042
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)