Identification of Neurocognitive Disorders by General Practitioners in Primary Care

Neurocognitive Disorders Clinical Trial

— TROCOMEGE  

Official title:

Identification of Neurocognitive Disorders by General Practitioners in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03678376
• Other study ID #: 69HCL18_0041
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: August 17, 2024

Study information

• Verified date: September 2023
• Source: Hospices Civils de Lyon
• Contact: Pierre Krolak Salmon, Pr
• Phone: 4 72 43 20 50
• Email: pierre.krolak-salmon[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Neurocognitive disorders (NCD) are today often largely underdiagnosed or diagnosed in late stages in France. Indeed the ALzheimer COoperative Valuation in Europe (ALCOVE) study stated that about 50% of people living with NCD remain undiagnosed until late severe stages with a deep autonomy loss inducing at risk behaviours and/or behavioural crisis. The French High Authority of Health (Haute Autorité de Santé - HAS) and ALCOVE recommend a timely diagnosis at a time when the specific intervention help to implement secondary or tertiary prevention dynamics that would delay severe complications and help to maintain a reasonable quality of life for both the patient and the caregiver. Moreover, the representatives of the National College of General Practitioners, the French Federation of Memory Centres, the French Federation of Gerontology and Geriatrics, the French Federation of Neurology, the French Society of Psychogeriatrics and the National Plan on Neurodegenerative Diseases designed a hierarchized and tailored diagnosis strategy of NCD promoting a shared diagnosis between the General Practitioner (GP) and specialists of NCD. It therefore appears crucial to determine the diagnosis value of a short duration strategy assessing the complaint, cognition and autonomy in primary care to detect NCD and referring to a specialist to perform the etiological diagnosis. The identification of NCD by GP in primary care (TROCOMEGE) study aims at assessing the positive and negative predictive values of a NCD diagnosis strategy through the assessment of the subjective memory complaint, the cognitive status and the autonomy level in primary care. It relies on the clinical impression of the GP, a cognitive complaint interview for complaint and functional assessment thanks to the General Practitioner assessment of Cognition (GP-Cog, part 2) tool and the cognitive assessment thanks to the Six-Item Cognitive Impairment test (6-CIT).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1018
• Est. completion date: August 17, 2024
• Est. primary completion date: August 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neurocognitive Disorders

Intervention

Other:
• complaint, cognitive and functional assessments
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.

Locations

Country	Name	City	State
France	Hôpital des Charpennes	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NCD diagnosis established by the GP by clinical impresson	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),	At inclusion
Primary	NCD diagnosis established by the GP using the GP-Cog part 2	a GP-cog score of 0-3 means no significant cognitive impairment; a GP-cog score of 4-6 means significant cognitive complaint	At inclusion
Primary	NCD diagnosis established by the GP using the 6-CIT test	a 6-CIT score between 0 and 7 means normal, referral not indicated at present; a 6-CIT score between 8 and 28 means mild or significant cognitive impairment	At inclusion
Primary	NCD diagnosis established in the memory clinics as reference by the Neuropsychologist using the DSM-5		at 3 months
Secondary	minor or major NCD diagnosis established by the GP		At inclusion
Secondary	minor or major NCD diagnosis established by the neuropsychologist using the DSM-5		At 3 months
Secondary	diagnosis value of each components of the GP strategy solely or in combination	Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, likelihood ratios will be calculated.	At inclusion
Secondary	level of cognitive performance established with the Mini Mental State Examination (MMSE)	A MMSE<18 being is considered as abnormal, MMSE between 18-23 is considered as questionable and MMSE >=24 is considered as normal)	At 3 months