Clinical Dementia Rating (CDR) From the Analysis of Medical RecordCLIMERNCT04763941
Clinical Dementia Rating Medical Record
An observational study of Clinical Dementia Rating (CDR) From the Analysis of Medical Record and Clinical Dementia Rating (CDR) Face-to-face Interview With the Patient, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The assessment of severity of the cognitive and functional impairment is essential in the follow-up of patients with neurocognitive disorders and in the assessment of the effectiveness of therapeutics. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Clinical Dementia Rating (CDR) From the Analysis of Medical Record, Clinical Dementia Rating (CDR) Face-to-face Interview With the Patient
- What is being tested?
- CDR assessment face-to-face
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Observational
- 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
Study population: The study will be conducted on the basis of the patient consulting in Memory Consultation, specifically with the information already collected in normal care and the MEMORA cohort.
Who may be able to join
- Patient who has CDR assessment in face-to-face interview during the memory consultation,
- Patient with an isolated cognitive complaint or a neurocognitive disorder
- Patient included in the MEMORA cohort
Who cannot join
- Patient or caregiver who does not wish their data to be used for research purposes within the framework of the MEMORA cohort.
Trial locations and contacts
1 site in 1 country.
Virginie Dauphinot contact
France1 site, 1 recruiting
- Recruiting
Hôpital Des Charpennes
Villeurbanne, 69100
Julien Vernaudon, MD, 4 72 432 227 ext. +33, julien.vernaudon@chu-lyon.fr
About this study
Official title: Reliability of the Clinical Dementia Rating Scale From the Medical Record in Comparison With the Reference Method.
The assessment of severity of the cognitive and functional impairment is essential in the follow-up of patients with neurocognitive disorders and in the assessment of the effectiveness of therapeutics. However, the systematic assessment of the Clinical Dementia Rating (CDR) scale is limited due to the time required to complete it (approximately 45 min to 1 hour). Insofar as studies have shown correspondences between the CDR and scales measuring cognitive and neuropsychological performance, and as part of memory consultations, several functional and neuropsychological scales are systematically administered, we wish to conduct a study validating the feasibility of the CDR based on information already available in the patient's file compared to the evaluation of the CDR by the usual method (face-to-face interview in consultation).
This study should highlight the feasibility of scoring the CDR-SB from the files of patients in memory consultation, first in terms of reliability of the scores obtained compared to the standard evaluation, and on the other hand in terms of organization and duration of administration.
- Conditions
- Clinical Dementia Rating (CDR) From the Analysis of Medical Record, Clinical Dementia Rating (CDR) Face-to-face Interview With the Patient
- Being tested
- CDR assessment face-to-face
- Keywords
- CDR, memory consultation, patient's file, reliability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDR assessment face-to-faceDiagnostic test
The assessment of the CDR is administered once by a psychologist with the patient and his caregiver.
| Study group | Role | What they receive |
|---|---|---|
| Memory consultation patient | The study will be conducted on the basis of the patient consulting in Memory Consultation, specifically with the information already collected in normal care and the MEMORA cohort. Receives: Diagnostic Test: CDR assessment face-to-face |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDR Sum of boxes (CDR-SB) score out of 18
The CDR-SB score is obtained in normal condition and on file for the same patients. The CDR-SB score makes it possible to distinguish the following classes: 0 (normal), 0.5-4 (questionable cognitive impairment), 0.5-2.5 (questionable impairment), 3-4 (very mild major TNC or very mild dementia), 4.5- 9 (mild or mild dementia), 9.5-15.5 (moderate dementia), 16-18 (severe dementia).
The patient's aptitudes are assessed in 6 different areas: 3 cognitive skills: memory, orientation and judgment, 3 acts of everyday living: participation in collective life, home occupations and hobbies, personal care.
Measured: The CDR-SB score is collected at the baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2020
- Primary completion1 Oct 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical Dementia Rating (CDR) From the Analysis of Medical RecordStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Bathsavanis, Psy D, Study director, Hôpital des CharpennesPierre Krolak-Salmon, MD, Principal investigator, Hopital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763941
- Sponsor's protocol ID
- 69HCL20_0508
- Acronym
- CLIMER
- Status last verified
- Jan 2022
- First submitted
- 17 Feb 2021
- Last updated
- 2 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dauphinot V, Calvi S, Moutet C, Xie J, Dautricourt S, Batsavanis A, Krolak-Salmon P, Garnier-Crussard A. Reliability of the assessment of the clinical dementia rating scale from the analysis of medical records in comparison with the reference method. Alzheimers Res Ther. 2024 Sep 5;16(1):198. doi: 10.1186/s13195-024-01567-9.
PubMed 39238042
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of the Clinical Dementia Rating Scale From the Medical Record in Comparison With the Reference Method.
- ClinicalTrials.gov ID
- NCT04763941
- Acronym / sponsor ID
- CLIMER / 69HCL20_0508
- Conditions
- Clinical Dementia Rating (CDR) From the Analysis of Medical Record, Clinical Dementia Rating (CDR) Face-to-face Interview With the Patient
- Keywords
- CDR, memory consultation, patient's file, reliability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Feb 2021 (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.
The assessment of severity of the cognitive and functional impairment is essential in the follow-up of patients with neurocognitive disorders and in the assessment of the effectiveness of therapeutics. However, the systematic assessment of the Clinical Dementia Rating (CDR) scale is limited due to the time required to complete it (approximately 45 min to 1 hour). Insofar as studies have shown correspondences between the CDR and scales measuring cognitive and neuropsychological performance, and as part of memory consultations, several functional and neuropsychological scales are systematically administered, we wish to conduct a study validating the feasibility of the CDR based on information already available in the patient's file compared to the evaluation of the CDR by the usual method (face-to-face interview in consultation).
This study should highlight the feasibility of scoring the CDR-SB from the files of patients in memory consultation, first in terms of reliability of the scores obtained compared to the standard evaluation, and on the other hand in terms of organization and duration of administration.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memory consultation patient | – | Diagnostic Test: CDR assessment face-to-faceThe study will be conducted on the basis of the patient consulting in Memory Consultation, specifically with the information already collected in normal care and the MEMORA cohort. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study will be conducted on the basis of the patient consulting in Memory Consultation, specifically with the information already collected in normal care and the MEMORA cohort.
Key inclusion criteria (3 listed)
- Patient who has CDR assessment in face-to-face interview during the memory consultation,
- Patient with an isolated cognitive complaint or a neurocognitive disorder
- Patient included in the MEMORA cohort
Key exclusion criteria (1 listed)
- Patient or caregiver who does not wish their data to be used for research purposes within the framework of the MEMORA cohort.
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 |
|---|---|---|
| CDR assessment face-to-faceThe assessment of the CDR is administered once by a psychologist with the patient and his caregiver. | Diagnostic test | Memory consultation patient |
Primary outcome
CDR Sum of boxes (CDR-SB) score out of 18
Time frame: The CDR-SB score is collected at the baseline.
The CDR-SB score is obtained in normal condition and on file for the same patients. The CDR-SB score makes it possible to distinguish the following classes: 0 (normal), 0.5-4 (questionable cognitive impairment), 0.5-2.5 (questionable impairment), 3-4 (very mild major TNC or very mild dementia), 4.5- 9 (mild or mild dementia), 9.5-15.5 (moderate dementia), 16-18 (severe dementia). The patient's aptitudes are assessed in 6 different areas: 3 cognitive skills: memory, orientation and judgment, 3 acts of everyday living: participation in collective life, home occupations and hobbies, personal care.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 39238042Dauphinot V, Calvi S, Moutet C, Xie J, Dautricourt S, Batsavanis A, Krolak-Salmon P, Garnier-Crussard A. Reliability of the assessment of the clinical dementia rating scale from the analysis of medical records in comparison with the reference method. Alzheimers Res Ther. 2024 Sep 5;16(1):198. doi: 10.1186/s13195-024-01567-9.
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.
Virginie Dauphinot contact
Anthony Bathsavanis, Psy D study director
Hôpital des Charpennes
Pierre Krolak-Salmon, MD principal investigator
Hopital Edouard Herriot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Dementia Rating (CDR) From the Analysis of Medical Record and Clinical Dementia Rating (CDR) Face-to-face Interview With the Patient, 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 3 inclusion and 1 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 2 May 2022. 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 Anthony Bathsavanis, Psy D (4 72 432 206 ext. +33, anthony.bathsavanis@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDR Sum of boxes (CDR-SB) score out of 18 (time frame: The CDR-SB score is collected at the baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04763941, which also lists 1 linked publication.
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 2 May 2022.