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

NCT ID: NCT05347043

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Sickle Cell Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Intervention

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)

Group Type EXPERIMENTAL

Montreal cognitive assessment

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Simon RECH, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Internal Medicine Department - Tenon

Paris, , France

Site Status

Countries

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France

Central Contacts

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Jean-Simon RECH, MD

Role: CONTACT

+33 156016791

Olivier Steichen, MD-PhD

Role: CONTACT

+33 156016791

Facility Contacts

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Jean-Simon RECH, MD

Role: primary

+33 156016791

Olivier Steichen, MD, PhD

Role: backup

+33 156016791

Other Identifiers

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IDRCB 2021-A01842-39

Identifier Type: OTHER

Identifier Source: secondary_id

APHP201174

Identifier Type: -

Identifier Source: org_study_id

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