Sickle Cell DiseaseDrépa-COGNCT04244240
Links Between Cognitive Functions and Clinical, Biological and Neuroradiological Outcomes in Adults With Sickle Cell Disease.
An observational study of Sickle Cell Disease and Drepanocytosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Sickle cell disease (SCD) is an inherited blood disorder. Symptoms include acute and chronic complications. Due to progress in SCD care, patients with SCD are living longer than before and we focus more attention in chronic complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease, Drepanocytosis
- What is being tested?
- BEARNI Tool
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2020to 5 Apr 2024
- Phase
- Observational
- 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
Study population: Adults with sickle cell disease and cognitive complaint
Who may be able to join
- Age ≥ 18 years old
- Sickle cell anemia (homozygous SS or heterozygous SC, Sβ0, S/C, Sβ+)
- In steady state (without vaso-occlusive crisis or acute chest syndrome at the time of measurements)
- Presence of spontaneous cognitive complaint or requested by the physician.
- Good command of the French language (native language or not)
- No objection to participate in the study
- Affiliated patient or beneficiary of social security scheme
Who cannot join
- Patient not compliant in the management of his disease
- Patient participating in another interventional research protocol that may interfere with this protocol (according to investigator's judgment)
- Language barrier
- Pregnancy or breast feeding
- MRI contraindication
- Patient under guardianship , curatorship or justice
- Inability to express non-opposition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Functions in Adults With Sickle Cell Disease and Cognitive Complaints: Neuropsychological Assessment and Links to Demographic, Clinical, Biological, Neuroradiological Outcomes and Validation of a Cognitive Assessment Tool.
Sickle cell disease (SCD) is an inherited blood disorder. Symptoms include acute and chronic complications. Due to progress in SCD care, patients with SCD are living longer than before and we focus more attention in chronic complications.
Children with SCD experience worse cognitive functions than healthy children, and fewer is known about cognitive functions in adults. Studies suggest lower cognitive performance in SCD, mostly in executive functions and processing speed, but the biological and anatomical substrates of cognitive decline are not yet well established in SCD. Often times, cognitive impairments and cerebral disorders are not diagnosed and treated in adults with SCD.
Read more
The main objective of this study is to propose a deep neuropsychological assessment in adults with SCD and cognitive complaints and to highlight links between cognitive functions and clinical, biological and neuroradiological markers. The hypothesis of this study is that cognitive functions are associated with severity of the SCD, with bood abnormalities, with MRI markers and Transcranial Doppler (TCD) markers of cerebrovascular disease. The secondary objective of this study is to validate a brief cognitive assessment tool (BEARNI tool) in adults with SCD.
This study is an observational cross-sectional study that will enroll adults with SCD and cognitive complaint.
- Conditions
- Sickle Cell Disease, Drepanocytosis
- Being tested
- BEARNI Tool
- Keywords
- Sickle Cell Disease, Drepanocytosis
- Medical subject headings
- Anemia, Sickle Cell, Sickle Cell Trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEARNI ToolBehavioural
BEARNI is brief screening tool initially validated for Alcohol-related neuropsychological impairments (Ritz et al., 2015). BEARNI tool detect impairment in visuospatial abilities, executive functions, verbal episodic memory, and verbal working memory.
The score of the test could be expressed as a global score, and also as subscores corresponding to each cognitive subtest. Normative data are available.
| Study group | Role | What they receive |
|---|---|---|
| Sickle cell disease patient | Adults with sickle cell disease (homozygous SS or heterozygous SC, Sβ0 or Sβ+) with cognitive complaint. Receives: Behavioral: BEARNI Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
BEARNI questionnaire
Cognitive performance will be evaluated by a large neuropsychological assessment. The cognitive score will be interpreted as raw scores, z-score adjusted for level of education, age, and sex, according to the tests and binarized into two categories (normal versus pathological performances)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start13 Oct 2020
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244240
- Sponsor's protocol ID
- 69HCL19_0753
- Other IDs
- 2019-A02709-48
- Acronym
- Drépa-COG
- Status last verified
- Mar 2025
- First submitted
- 23 Jan 2020
- Last updated
- 7 Mar 2025
- 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Functions in Adults With Sickle Cell Disease and Cognitive Complaints: Neuropsychological Assessment and Links to Demographic, Clinical, Biological, Neuroradiological Outcomes and Validation of a Cognitive Assessment Tool.
- ClinicalTrials.gov ID
- NCT04244240
- Acronym / sponsor ID
- Drépa-COG / 69HCL19_0753
- Conditions
- Sickle Cell Disease, Drepanocytosis
- Keywords
- Sickle Cell Disease, Drepanocytosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 28 Jan 2020 (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.
Sickle cell disease (SCD) is an inherited blood disorder. Symptoms include acute and chronic complications. Due to progress in SCD care, patients with SCD are living longer than before and we focus more attention in chronic complications.
Children with SCD experience worse cognitive functions than healthy children, and fewer is known about cognitive functions in adults. Studies suggest lower cognitive performance in SCD, mostly in executive functions and processing speed, but the biological and anatomical substrates of cognitive decline are not yet well established in SCD. Often times, cognitive impairments and cerebral disorders are not diagnosed and treated in adults with SCD.
The main objective of this study is to propose a deep neuropsychological assessment in adults with SCD and cognitive complaints and to highlight links between cognitive functions and clinical, biological and neuroradiological markers. The hypothesis of this study is that cognitive functions are associated with severity of the SCD, with bood abnormalities, with MRI markers and Transcranial Doppler (TCD) markers of cerebrovascular disease. The secondary objective of this study is to validate a brief cognitive assessment tool (BEARNI tool) in adults with SCD.
This study is an observational cross-sectional study that will enroll adults with SCD and cognitive complaint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle cell disease patient | – | Behavioral: BEARNI ToolAdults with sickle cell disease (homozygous SS or heterozygous SC, Sβ0 or Sβ+) with cognitive complaint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with sickle cell disease and cognitive complaint
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Sickle cell anemia (homozygous SS or heterozygous SC, Sβ0, S/C, Sβ+)
- In steady state (without vaso-occlusive crisis or acute chest syndrome at the time of measurements)
- Presence of spontaneous cognitive complaint or requested by the physician.
- Good command of the French language (native language or not)
Key exclusion criteria (7 listed)
- Patient not compliant in the management of his disease
- Patient participating in another interventional research protocol that may interfere with this protocol (according to investigator's judgment)
- Language barrier
- Pregnancy or breast feeding
- MRI contraindication
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 |
|---|---|---|
| BEARNI ToolBEARNI is brief screening tool initially validated for Alcohol-related neuropsychological impairments (Ritz et al., 2015). BEARNI tool detect impairment in visuospatial abilities, executive functions, verbal episodic memory, and verbal working memory. The score of the test could be expressed as a global score, and also as subscores corresponding to each cognitive subtest. Normative data are available. | Behavioural | Sickle cell disease patient |
Primary outcome
BEARNI questionnaire
Time frame: Day 0
Cognitive performance will be evaluated by a large neuropsychological assessment. The cognitive score will be interpreted as raw scores, z-score adjusted for level of education, age, and sex, according to the tests and binarized into two categories (normal versus pathological performances)
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 7 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Drepanocytosis, run by Hospices Civils de Lyon 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 7 inclusion and 7 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 7 Mar 2025. 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?
BEARNI questionnaire (time frame: Day 0). 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 7 Mar 2025.