Neurocognitive DisordersTROCOMEGENCT03678376
Identification of Neurocognitive Disorders by General Practitioners in Primary Care
A study testing complaint, cognitive and functional assessments in people with Neurocognitive Disorders, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neurocognitive Disorders
- What is being tested?
- complaint, cognitive and functional assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,018 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2020to 17 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital des Charpennes
Villeurbanne, 69100
Pierre Krolak Salmon, Pr, 4 72 43 20 50 ext. +33, pierre.krolak-salmon@chu-lyon.fr
About this study
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).
- Conditions
- Neurocognitive Disorders
- Being tested
- complaint, cognitive and functional assessments
- Keywords
- Diagnostic strategy, Neurocognitive disorders, Primary Care
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complaint, cognitive and functional assessmentsOther
Also called Evaluation of a new rapid diagnostic strategy for general practitioners assessing complaint, cognition and autonomy in primary care to identify neurocognitive disorders at different stages
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.
| Study group | Role | What they receive |
|---|---|---|
| complaint, cognitive and functional assessments | Other | 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). Receives: Other: complaint, cognitive and functional assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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),
Measured: At inclusion
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
Measured: At inclusion
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
Measured: At inclusion
NCD diagnosis established in the memory clinics as reference by the Neuropsychologist using the DSM-5
Measured: at 3 months
Secondary outcomes (4)
minor or major NCD diagnosis established by the GP
Measured: At inclusion
minor or major NCD diagnosis established by the neuropsychologist using the DSM-5
Measured: At 3 months
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.
Measured: At inclusion
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)
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start17 Feb 2020
- Primary completion17 Aug 2024 (estimated)
- Study completion17 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,018 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Krolak Salmon, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678376
- Sponsor's protocol ID
- 69HCL18_0041
- Acronym
- TROCOMEGE
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Neurocognitive Disorders by General Practitioners in Primary Care
- ClinicalTrials.gov ID
- NCT03678376
- Acronym / sponsor ID
- TROCOMEGE / 69HCL18_0041
- Conditions
- Neurocognitive Disorders
- Keywords
- Diagnostic strategy, Neurocognitive disorders, Primary Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,018 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 17 Aug 2024 (estimated)
- Study completion
- 17 Aug 2024 (estimated)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| complaint, cognitive and functional assessments | Other | Other: complaint, cognitive and functional assessmentsAll 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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| complaint, cognitive and functional assessmentsAlso: Evaluation of a new rapid diagnostic strategy for general practitioners assessing complaint, cognition and autonomy in primary care to identify neurocognitive disorders at different stagesThe 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 | complaint, cognitive and functional assessments |
Primary outcome
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),
NCD diagnosis established by the GP using the GP-Cog part 2
Time frame: At inclusion
* a GP-cog score of 0-3 means no significant cognitive impairment * a GP-cog score of 4-6 means significant cognitive complaint
NCD diagnosis established by the GP using the 6-CIT test
Time frame: At inclusion
* 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
NCD diagnosis established in the memory clinics as reference by the Neuropsychologist using the DSM-5
Time frame: at 3 months
4 secondary outcomes
minor or major NCD diagnosis established by the GP
Time frame: At inclusion
minor or major NCD diagnosis established by the neuropsychologist using the DSM-5
Time frame: At 3 months
diagnosis value of each components of the GP strategy solely or in combination
Time frame: At inclusion
level of cognitive performance established with the Mini Mental State Examination (MMSE)
Time frame: At 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Krolak Salmon, Pr principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing complaint, cognitive and functional assessments in people with Neurocognitive Disorders, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Krolak Salmon, Pr (4 72 43 20 50 ext. +33, pierre.krolak-salmon@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NCD diagnosis established by the GP by clinical impresson (time frame: At inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.