The Montreal Cognitive Assessment.Test in Adults With Sickle Cell Disease

Sickle Cell Anemia Clinical Trial

— EvaCAD  

Official title:

Evaluation of the Montreal Cognitive Assessment Test as a Screening Tool for Cognitive Dysfunction in in Adults With Sickle Cell Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05347043
• Other study ID #: APHP201174
• Secondary ID: IDRCB 2021-A0184
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: June 2023

Study information

• Verified date: May 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jean-Simon RECH, MD
• Phone: +33 156016791
• Email: jeansimon.rech[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the performances of the Montreal Cognitive Assessment (MoCA) to screen for cognitive impairment in adults with sickle cell anemia. The results of the MoCA and its subscores will be compared to a standardized neuropsychological evaluation using validated tests.

Description:

Sickle cell anemia is a monogenic disease affecting the beta-chain of hemoglobin. Cognitive impairment is more prevalent in patients with sickle cell disease than in matched unaffected individuals. Validated tests to screen for cognitive impairment are lacking in this population. Our goal is therefore to assess the performance of the Montreal Cognitive Assessment (MoCA) as a screening tool for cognitive impairment in adults with sickle cell anemia. The results of the MoCA and its subscales will be compared to a standardized neuropsychological evaluation using validated tests.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 59
• Est. completion date: June 2023
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sickle cell disease, SS or SBêta0 subtypes only
• Attending a consultation or a daycare hospitalization in the Tenon hospital sickle cell center
• Aged 18 years old or more
• Providing written informed consent
• With Health Insurance

Exclusion Criteria:

• Obvious cognitive impairment of neurologic (e.g. previous stroke) or psychiatric origin (e.g. psychotic disorder with negative symptoms)
• Insufficient French language fluency to understand the tests, inability to read and write or with no schooling beyond primary school
• Anticipated unavailability in the next 6 months
• Patients under supervision & guardianship

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Cognitive Dysfunction
• Sickle Cell Anemia

Intervention

Other:
• Montreal cognitive assessment
Montreal cognitive assessment and standardized neuropsychological evaluation (Test of Attentional Performance of Zimmermann and Fimm ; Wechsler Adult Intelligence Scale 4th version digit span ; Wechsler memory scale III, spatial span ; Wisconsin Card Scoring Test, GREFEX version ; Wechsler Adult Intelligence Scale 4th version block design ; Six elements test GREFEX version; free and cued selective reminding test, 16 items, B version ; Behavioral Rating Inventory of Executive Function ; Modified Fatigue Impact Scale)

Locations

Country	Name	City	State
France	Internal Medicine Department - Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity of a Montreal Cognitive Assessment score < 26 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation	sensitivity of a Montreal Cognitive Assessment score < 26 to detect cognitive impairment defined as an abnormal result in at least one of the following tests : Test of Attentional Performance of Zimmermann and and Fimm (< 5th percentile in at least one of the subscales) ; Wechsler Adult Intelligence Scale 4th version digit span (standard score = 5) ; Wechsler memory scale III, spatial span (standard score = 5) ; Wisconsin Card Scoring Test, GREFEX version (number of categories = 5th percentile or if the number of perseverations is = 95th percentile) Wechsler Adult Intelligence Scale 4th version block design (standard score = 5) ; Six elements test GREFEX version (rank score = 5th percentile ); free and cued selective reminding test, 16 items, B version (Z-score = -1,65 in at least one of the subscales)	Month 3
Secondary	specificity of a Montreal Cognitive Assessment score < 26 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation	specificity of a Montreal Cognitive Assessment score < 26 to detect cognitive impairment defined as an abnormal result in at least one of the following tests : Test of Attentional Performance of Zimmermann and Fimm (< 5th percentile in at least one of the subscales) ; Wechsler Adult Intelligence Scale 4th version digit span (standard score = 5) ; Wechsler memory scale III, spatial span (standard score = 5) ; Wisconsin Card Scoring Test, GREFEX version (number of categories = 5th percentile or if the number of perseverations is = 95th percentile); Wechsler Adult Intelligence Scale 4th version block design (standard score = 5) ; Six elements test GREFEX version (rank score = 5th percentile); free and cued selective reminding test, 16 items, B version (Z-score = -1,65 in at least one of the subscales)	Month 3
Secondary	sensitivity of a Montreal Cognitive Assessment score < 23 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation	sensitivity of a Montreal Cognitive Assessment score < 23 to detect cognitive impairment defined as an abnormal result in at least one of the following tests : Test of Attentional Performance of Zimmermann and Fimm (< 5th percentile in at least one of the subscales) ; Wechsler Adult Intelligence Scale 4th version digit span (standard score = 5) ; Wechsler memory scale III, spatial span (standard score = 5) ; Wisconsin Card Scoring Test, GREFEX version (number of categories = 5th percentile or if the number of perseverations is = 95th percentile); Wechsler Adult Intelligence Scale 4th version block design (standard score = 5) ; Six elements test GREFEX version (rank score = 5th percentile) ; free and cued selective reminding test, 16 items, B version (Z-score = -1,65 in at least one of the subscales)	Month 3
Secondary	sensitivity and specificity of a score = 5/6 in the attention subscale of the Montreal Cognitive Assessment to detect attentional impairment confirmed by a neuropsychological standardized evaluation	sensitivity and specificity of a score = 5/6 in the attention subscale of the Montreal Cognitive Assessment to detect attentional impairment as defined by a Test of Attentional Performance of Zimmermann and Fimm < 5th percentile in at least one of the subscales of the test	Month 3
Secondary	sensitivity and specificity of a score = 4/5 in the visuospatial/executive subscale of the Montreal Cognitive Assessment to detect executive impairment confirmed by a neuropsychological standardized evaluation	sensitivity and specificity of a score = 4/5 in the visuospatial/executive subscale of the Montreal Cognitive Assessment to detect executive impairment as defined by an abnormal result in one of the following test : Wisconsin Card Scoring Test, GREFEX version (number of categories = 5th percentile or if the number of perseverations is = 95th percentile); Wechsler Adult Intelligence Scale 4th version block design (standard score = 5) ; Six elements test GREFEX version (rank score = 5th percentile )	Month 3
Secondary	sensitivity and specificity of a score = 4/5 in the delayed recall subscale of the Montreal Cognitive Assessment to detect a long term memory impairment confirmed by a neuropsychological standardized evaluation	sensitivity and specificity of a score = 4/5 in the attention subscale of the Montreal Cognitive Assessment to detect attentional impairment as defined by a free and cued selective reminding test, 16 items, B version Z-score = -1,65 (in at least one of the subscales)	Month 3