Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04763941
Other study ID # 69HCL20_0508
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2022

Study information

Verified date January 2022
Source Hospices Civils de Lyon
Contact Anthony Bathsavanis, Psy D
Phone 4 72 432 206
Email anthony.bathsavanis@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 144
Est. completion date December 31, 2022
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Alzheimer Disease
  • Clinical Dementia Rating (CDR) Face-to-face Interview With the Patient
  • Clinical Dementia Rating (CDR) From the Analysis of Medical Record
  • Dementia

Intervention

Diagnostic Test:
CDR assessment face-to-face
The assessment of the CDR is administered once by a psychologist with the patient and his caregiver.

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 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.
The CDR-SB score is collected at the baseline.