- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04763941
Clinical Dementia Rating Medical Record (CLIMER)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Anthony Bathsavanis, Psy D
- Phone Number: +33 4 72 432 206
- Email: anthony.bathsavanis@chu-lyon.fr
Study Contact Backup
- Name: Virginie Dauphinot
- Email: virginie.dauphinot@chu-lyon.fr
Study Locations
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-
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Villeurbanne, France, 69100
- Recruiting
- Hopital des Charpennes
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Contact:
- Julien Vernaudon, MD
- Phone Number: +33 4 72 432 227
- Email: julien.vernaudon@chu-lyon.fr
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient or caregiver who does not wish their data to be used for research purposes within the framework of the MEMORA cohort.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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The assessment of the CDR is administered once by a psychologist with the patient and his caregiver.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
The CDR-SB score is collected at the baseline.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Anthony Bathsavanis, Psy D, Hopital des Charpennes
- Principal Investigator: Pierre Krolak-Salmon, MD, Hôpital Edouard Herriot
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL20_0508
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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