- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03678376
Identification of Neurocognitive Disorders by General Practitioners in Primary Care (TROCOMEGE)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pierre Krolak Salmon, Pr
- Phone Number: +33 4 72 43 20 50
- Email: pierre.krolak-salmon@chu-lyon.fr
Study Locations
-
-
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Villeurbanne, France, 69100
- Recruiting
- Hôpital des Charpennes
-
Contact:
- Pierre Krolak Salmon, Pr
- Phone Number: +33 4 72 43 20 50
- Email: pierre.krolak-salmon@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient aged 65 and over,
- Patient expressing a cognitive complaint (memory, language, sense of time and place disorientation for example) to his/her general practitioner; the complaint can be provided by an informal caregiver and /or, presenting with "at risk" behaviour* possibly related to a NCD (mistaking medicine or forgetting medical consultation, forgetting hot meals, losing him/herself for example…),
- Patients able to understand the specifications of the study and to realize it (vision, audition, language…)
- Patient who has been informed and has consented to the study (himself/herself and by a trusted person/a family member if applicable) as established by the "article L. 1121-8 du Code de la Santé Publique".
- Registered with a social security system
Exclusion Criteria:
- Institutionalized patients
- Patients unable to understand the purpose of the study,
- Patients with neurocognitive disorders already diagnosed
- Patients under legal protection
- Patients with auditory or visual disorders which do not allow to perform the assessment
- Patients who do not want to go to the Memory Clinic
- Patients with severe disease commit the prognosis in relatively short term
- Participation to another trial that would interfere with the present study
- Patient with severe anxiety or depression preventing from any reliable neuropsychological assessment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: complaint, cognitive and functional assessments
All patients will be included in a single arm.
They will complete an evaluation with their General Practitioner, followed by an evaluation at the Memory Clinic with a specialist (neurologist, geriatrician or psychiatrist).
|
The evaluation with their GP is composed of (1-) Clinical impression, (2-) GP-Cog part 2 with patient or their informal caregiver and (3-) 6-CIT test. The identification of patients at risk of NCD with the new strategy applied by the GP will be compared to the gold standard for diagnosis of NCD at the Memory Clinic, established according to Diagnosis and Statistical Manual of mental disorders (DSM-5) criteria and based on a clinical, neuropsychological evaluation and functional abilities. If needed, a secondary etiological diagnosis procedure will be undertaken following the HAS 2011 recommendation including brain MRI and biology.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NCD diagnosis established by the GP by clinical impresson
Time Frame: At inclusion
|
the GP will have to respond to the following issues 1- Does he think the patient presents a suspect cognitive complaint (Yes/No) 2- does he think the patient presents with a NCD (Yes/No),
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At inclusion
|
NCD diagnosis established by the GP using the GP-Cog part 2
Time Frame: At inclusion
|
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At inclusion
|
NCD diagnosis established by the GP using the 6-CIT test
Time Frame: At inclusion
|
|
At inclusion
|
NCD diagnosis established in the memory clinics as reference by the Neuropsychologist using the DSM-5
Time Frame: at 3 months
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at 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
minor or major NCD diagnosis established by the GP
Time Frame: At inclusion
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At inclusion
|
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minor or major NCD diagnosis established by the neuropsychologist using the DSM-5
Time Frame: At 3 months
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At 3 months
|
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diagnosis value of each components of the GP strategy solely or in combination
Time Frame: At inclusion
|
Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, likelihood ratios will be calculated.
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At inclusion
|
level of cognitive performance established with the Mini Mental State Examination (MMSE)
Time Frame: At 3 months
|
A MMSE<18 being is considered as abnormal, MMSE between 18-23 is considered as questionable and MMSE >=24 is considered as normal)
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At 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre Krolak Salmon, Pr, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL18_0041
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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