Sickle Cell AnemiaEvaCADNCT05347043
The Montreal Cognitive Assessment.Test in Adults With Sickle Cell Disease
A study testing Montreal cognitive assessment in people with Sickle Cell Anemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Anemia
- What is being tested?
- Montreal cognitive assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2022to 14 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Montreal Cognitive Assessment Test as a Screening Tool for Cognitive Dysfunction in in Adults With Sickle Cell Disease
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.
Read the 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.
- Conditions
- Sickle Cell Anemia
- Being tested
- Montreal cognitive assessment
- Keywords
- Sickle cell anemia, cognitive dysfunction, sensitivity and specificity, Diagnostic Techniques and Procedures, Neuropsychological Tests, Montreal cognitive assessment
- Medical subject headings
- Anemia, Sickle Cell, Cognitive Dysfunction, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montreal cognitive assessmentOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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) Receives: Other: Montreal cognitive assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Month 3
Secondary outcomes (5)
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)
Measured: Month 3
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)
Measured: Month 3
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
Measured: Month 3
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 )
Measured: Month 3
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)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start20 Oct 2022
- Primary completion11 Apr 2024
- Study completion14 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Simon RECH, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347043
- Sponsor's protocol ID
- APHP201174
- Other IDs
- IDRCB 2021-A01842-39
- Acronym
- EvaCAD
- Status last verified
- Feb 2026
- First submitted
- 20 Apr 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Montreal Cognitive Assessment Test as a Screening Tool for Cognitive Dysfunction in in Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT05347043
- Acronym / sponsor ID
- EvaCAD / APHP201174
- Conditions
- Sickle Cell Anemia
- Keywords
- Sickle cell anemia, cognitive dysfunction, sensitivity and specificity, Diagnostic Techniques and Procedures, Neuropsychological Tests, Montreal cognitive assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Montreal cognitive assessmentAll 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montreal cognitive assessmentMontreal 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) | Other | Intervention |
Primary outcome
sensitivity of a Montreal Cognitive Assessment score < 26 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation
Time frame: Month 3
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)
5 secondary outcomes
specificity of a Montreal Cognitive Assessment score < 26 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation
Time frame: Month 3
sensitivity of a Montreal Cognitive Assessment score < 23 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation
Time frame: Month 3
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
Time frame: Month 3
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
Time frame: Month 3
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
Time frame: Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Sickle Cell Anemia
Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Simon RECH, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montreal cognitive assessment in people with Sickle Cell Anemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of a Montreal Cognitive Assessment score < 26 to detect cognitive impairment confirmed by a neuropsychological standardized evaluation (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.