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

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Sickle Cell Anemia

Treatments: Other: Montreal cognitive assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT05347043

IDRCB 2021-A01842-39 (Other Identifier)

APHP201174

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Intervention

Experimental group

Description:

All patients will undergo both the MoCA test and the standardized neuropsychological evaluation 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)

Treatment:

Other: Montreal cognitive assessment