Clinical trial NCT05347043: The Montreal Cognitive Assessment.Test in Adults With Sickle Cell Disease
Official title: Evaluation of the Montreal Cognitive Assessment Test as a Screening Tool for Cognitive Dysfunction in in Adults With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sickle Cell Anemia
Keywords: Sickle cell anemia
cognitive dysfunction
sensitivity and specificity
Diagnostic Techniques and Procedures
Neuropsychological Tests
Montreal cognitive assessment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: sensitivity of a Montreal Cognitive Assessment score < 26 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation
timeFrame: Month 3
Secondary outcomes:
measure: specificity of a Montreal Cognitive Assessment score < 26 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation
timeFrame: Month 3
measure: sensitivity of a Montreal Cognitive Assessment score < 23 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation
timeFrame: Month 3
measure: 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
timeFrame: Month 3
measure: 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
timeFrame: Month 3
measure: 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
timeFrame: Month 3
Other outcomes:
Locations:
city: Paris
country: France
facility: Internal Medicine Department - Tenon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Simon RECH, MD
role: PRINCIPAL_INVESTIGATOR
References: