Circadian Rhythm and Other Individual Factors Among Memory Clinic Patients
Study explores daily rhythms and factors linked to dementia types and stages.
Plain English Summary
Circadian Rhythm and Other Factors in Memory Clinic Patients is a Not Applicable clinical trial sponsored by Assistance Publique - Hôpitaux de Paris studying Dementia. This study tests how daily body rhythms and other personal factors relate to different types and stages of dementia. It is for adults who are patients at memory clinics in Paris. Participation involves questionnaires, clinical exams, wearing a device to track activity for 9 days, and eye/ear exams. There are no direct treatment alternatives offered within this observational study. The trial aims to enroll 1200 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and over who are patients at participating memory clinics in Paris can join. You cannot join if you have a skin allergy to plastic, a psychiatric disorder that explains your cognitive symptoms, or are participating in another study that might affect your body rhythms. Individuals who cannot attend appointments alone or need assistance (e.g., use a wheelchair) may not be able to participate. Participants must be affiliated with the French social security system. This trial is studying Dementia, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure how often different types and stages of dementia are identified at the start of the study and how they develop over time, helping to understand the disease's patterns. The specific primary outcome measures are: Dementia subtypes and stages (% at inclusion) (At inclusion); Dementia subtypes and stages (incidence) (From inclusion until last routine visit at the memory clinic within the 15 years following inclusion); Alzheimer's disease stages (%) (At inclusion); Alzheimer's disease stages (change in) (From inclusion until last routine visit at the memory clinic within the 15 years following inclusion). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to find new ways to identify dementia subtypes and stages early, potentially improving primary care screening and understanding disease progression. This research targets Dementia, where improved treatment options are needed.
Investor Insight
This observational study focuses on identifying risk factors for dementia, which could inform future diagnostic tools and treatments, a significant area given the growing prevalence of dementia. The large enrollment target of 1200 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if this study is right for you and what the 9-day accelerometer wear entails. Be prepared to answer detailed questions about your lifestyle, health, and daily habits. You will undergo various medical tests, including cognitive assessments, blood work, and specialized eye and ear examinations. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 1,200 participants
Interventions
- OTHER: Questionnaire — 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).
- OTHER: Clinical examination — 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).
- OTHER: Accelerometer port — Participants will be wearing an accelerometer for 9 days.
- OTHER: Eye examination — Eye fundus photo, OCT and OCT-A exams
- OTHER: Ear Examination — Otoscopic examination, Wideband tympanometry, Pure-tone and speech audiometry (in quiet and in noise), Auditory evoked potentials, Electroencephalogram with auditory stimulation
Primary Outcomes
- Dementia subtypes and stages (% at inclusion) (At inclusion)
- Dementia subtypes and stages (incidence) (From inclusion until last routine visit at the memory clinic within the 15 years following inclusion)
- Alzheimer's disease stages (%) (At inclusion)
- Alzheimer's disease stages (change in) (From inclusion until last routine visit at the memory clinic within the 15 years following inclusion)
Secondary Outcomes
- 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)
Full 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
Trial Locations
- Centre de neurologie Cognitive / CMRR, Paris, France, France
- Hôpital de Jour Gériatrique et consultation mémoire, Paris, France, France
Frequently Asked Questions
What is clinical trial NCT05977712?
NCT05977712 is a Not Applicable OBSERVATIONAL study titled "Circadian Rhythm and Other Factors in Memory Clinic Patients." It is currently recruiting and is sponsored by Assistance Publique - Hôpitaux de Paris. The trial targets enrollment of 1200 participants.
What conditions does NCT05977712 study?
This trial investigates treatments for Dementia. The primary condition under study is Dementia.
What treatments are being tested in NCT05977712?
The interventions being studied include: Questionnaire (OTHER), Clinical examination (OTHER), Accelerometer port (OTHER), Eye examination (OTHER), Ear Examination (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).
What does Not Applicable mean for NCT05977712?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05977712?
This trial is currently "Recruiting." It started on 2024-03-06. The estimated completion date is 2042-03.
Who is sponsoring NCT05977712?
NCT05977712 is sponsored by Assistance Publique - Hôpitaux de Paris. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05977712?
The trial aims to enroll 1200 participants. The trial is currently recruiting and accepting new participants.
How is NCT05977712 designed?
This is a observational study.
What are the primary outcomes being measured in NCT05977712?
The primary outcome measures are: Dementia subtypes and stages (% at inclusion) (At inclusion); Dementia subtypes and stages (incidence) (From inclusion until last routine visit at the memory clinic within the 15 years following inclusion); Alzheimer's disease stages (%) (At inclusion); Alzheimer's disease stages (change in) (From inclusion until last routine visit at the memory clinic within the 15 years following inclusion). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05977712 being conducted?
This trial is being conducted at 2 sites, including Paris, France (France).
Where can I find official information about NCT05977712?
The official record for NCT05977712 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05977712. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05977712 testing in simple terms?
This study tests how daily body rhythms and other personal factors relate to different types and stages of dementia. It is for adults who are patients at memory clinics in Paris.
Why is this trial significant?
This trial matters because it aims to find new ways to identify dementia subtypes and stages early, potentially improving primary care screening and understanding disease progression.
What are the potential risks of participating in NCT05977712?
Potential risks include minor discomfort from wearing the accelerometer or possible skin irritation. Some participants might experience fatigue or temporary inconvenience due to the study procedures. There is a small risk of allergic reaction to the adhesive used for the accelerometer. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05977712?
Ask your doctor if this study is right for you and what the 9-day accelerometer wear entails. Be prepared to answer detailed questions about your lifestyle, health, and daily habits. You will undergo various medical tests, including cognitive assessments, blood work, and specialized eye and ear examinations. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05977712 signal from an investment perspective?
This observational study focuses on identifying risk factors for dementia, which could inform future diagnostic tools and treatments, a significant area given the growing prevalence of dementia. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves questionnaires, clinical exams, wearing a device to track activity for 9 days, and eye/ear exams. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Dementia Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.