Cushing's DiseaseMEMOCUSHNCT02603653
Assessment of Persistent Cognitive Impairment After Cure of Cushing's Disease
A study testing Virtual radial task in 3D in people with Cushing's Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Cushing's disease is a state of chronic endogenous glucocorticoid excess. Cushing's disease is responsible for increased morbidity and mortality. Recent studies have pinpointed the frequency of somatic sequelas and persistent alteration in quality of life despite the cure of the disease. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cushing's Disease
- What is being tested?
- Virtual radial task in 3D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2016to 3 Aug 2017
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients :
- history of Cushing's Disease
- aged : 18 - 60 years
- Biological remission of Cushing's disease for at least one year
- Affiliation to Social Security
- Informed consent signed by patient and investigator (at the latest the inclusion's day, before study's exams)
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- For controls :
- People aged 18 to 60 years matched to patients for age, sex and educational level
- Affiliation to Social Security
- Informed consent signed by patient and investigator (at the latest the inclusion's day, before study's exams)
Who cannot join
- For patients :
- Persistent hypercortisolism (even mild)
- Current treatment of hypercortisolism with drugs
- Obesity (BMI >30 kg/m²)
- Alcohol or drug addiction present or past
- Growth hormone deficit
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- Diabetes mellitus with hemoglobin A1c > 7.5% and/or fasting blood glucose > 1.4 g/L
- History of pituitary radiotherapy
- History of cerebrovascular or neuro-cerebral disease
- untreated dysthyroidism
- Current psychotropic drug treatment
- Pregnancy
- Use of glucocorticoids in the last 3 months before study (aside hydrocortisone replacement therapy)
- Excessive hydrocortisone replacement therapy (unadjusted to weight and/or with evening administration)
- For controls :
- Obesity (BMI >30 kg/m²)
- Alcohol or drug addiction present or past
- Current psychotropic drug treatment
- History of cerebrovascular or neuro-cerebral disease
- Current pregnancy
- Chronical use of corticoid (> 1 month), current or past
- Use of glucocorticoids in the last 3 months before study (aside hydrocortisone replacement therapy)
- Diabetes mellitus with hemoglobin A1c > 7.5% and/or fasting blood glucose > 1.4 g/L
- Obesity (BMI >30 kg/m²)
- untreated dysthyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Sequels of Cushing Syndrome
Cushing's disease is a state of chronic endogenous glucocorticoid excess. Cushing's disease is responsible for increased morbidity and mortality. Recent studies have pinpointed the frequency of somatic sequelas and persistent alteration in quality of life despite the cure of the disease. More specifically, a few studies have described persistent psychopathology, maladaptive personality and cognitive impairments in patients with a history of Cushing's disease. Among these, hippocampal memory deficits have been found in the majority of studies, a finding that is consistent with the alterations described in hippocampal neurons during chronic exposure to glucocorticoids. However, the tools currently available to assess hippocampal-dependent memory are multiple, sometimes difficult to perform by clinicians and to analyze or may lack of diagnostic sensitivity. The investigators have recently developed an original tool, the virtual radial task in 3D, which has shown to be reliable to detect subtle alterations in hippocampal-dependent memory in several human diseases. The primary aim of the study is the evaluation of persistent cognitive impairments (hippocampal memory) in patients cured of Cushing's disease for at least one year using the virtual radial task in 3D and to compare it with that obtained with classical cognitive tests.
- Conditions
- Cushing's Disease
- Being tested
- Virtual radial task in 3D
- Medical subject headings
- Pituitary ACTH Hypersecretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual radial task in 3DDevice
The virtual radial task is a labyrinth in 3D with twelve ways. The primary aim of our study is the evaluation of persistent cognitive impairments (hippocampal memory) according to the responses of participants after instructions to choose the right way in the labyrinth.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Virtual radial task in 3D Receives: Device: Virtual radial task in 3D |
| Controls | Experimental | Virtual radial task in 3D Receives: Device: Virtual radial task in 3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of right answers at virtual radial task in 3D
Comparison of right answers in patients cured of Cushing's disease and in controls.
Measured: baseline
Secondary outcomes (6)
General Quality of life
Comparison of quality of life of patients and controls with validated general questionnaire : SF-36 (SF for Short Form health survey)
Measured: baseline
Specific Quality of life for Cushing's Disease
Comparison of quality of life of patients and controls with validated specific questionnaire for Cushing's Disease : Cushing-QoL
Measured: baseline
Number of participants with anxiety
Evaluation of anxiety in the two groups with Hospital Anxiety and Depression Scale (HADS) scale (questionnaire)
Measured: baseline
Number of participants with depression with MADRS
Evaluation of depression in the two groups with Montgomery and Asberg Depression Rating Scale (MADRS) (questionnaire)
Measured: baseline
Number of participants with depression with HADS
Evaluation of depression in the two groups with Hospital Anxiety and Depression Scale (HADS) scale (questionnaire)
Measured: baseline
Intensity of Cushing's syndrome
Intensity of Cushing's disease will be evaluated with mean of free urinary cortisol. Hypothesis : intensity of hypercortisolism is correlated with sequels after cure.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start4 Feb 2016
- Primary completion12 Feb 2017
- Study completion3 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cushing's DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Antoine Tabarin, Pr, Principal investigator, Hôpital Haut Lévêque - Pessac (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603653
- Sponsor's protocol ID
- C15-02
- Other IDs
- IDRCB
- Acronym
- MEMOCUSH
- Status last verified
- Nov 2015
- First submitted
- 3 Nov 2015
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Pupier E, Santos A, Etchamendy N, Lavielle A, Ferriere A, Marighetto A, Resmini E, Cota D, Webb SM, Tabarin A. Impaired quality of life, but not cognition, is linked to a history of chronic hypercortisolism in patients with Cushing's disease in remission. Front Endocrinol (Lausanne). 2022 Aug 8;13:934347. doi: 10.3389/fendo.2022.934347. eCollection 2022.
PubMed 36004342
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Sequels of Cushing Syndrome
- ClinicalTrials.gov ID
- NCT02603653
- Acronym / sponsor ID
- MEMOCUSH / C15-02
- Conditions
- Cushing's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- 12 Feb 2017 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 13 Nov 2015 (estimated)
- 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.
Cushing's disease is a state of chronic endogenous glucocorticoid excess. Cushing's disease is responsible for increased morbidity and mortality. Recent studies have pinpointed the frequency of somatic sequelas and persistent alteration in quality of life despite the cure of the disease. More specifically, a few studies have described persistent psychopathology, maladaptive personality and cognitive impairments in patients with a history of Cushing's disease. Among these, hippocampal memory deficits have been found in the majority of studies, a finding that is consistent with the alterations described in hippocampal neurons during chronic exposure to glucocorticoids. However, the tools currently available to assess hippocampal-dependent memory are multiple, sometimes difficult to perform by clinicians and to analyze or may lack of diagnostic sensitivity. The investigators have recently developed an original tool, the virtual radial task in 3D, which has shown to be reliable to detect subtle alterations in hippocampal-dependent memory in several human diseases. The primary aim of the study is the evaluation of persistent cognitive impairments (hippocampal memory) in patients cured of Cushing's disease for at least one year using the virtual radial task in 3D and to compare it with that obtained with classical cognitive tests.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: Virtual radial task in 3DVirtual radial task in 3D |
| Controls | Experimental | Device: Virtual radial task in 3DVirtual radial task in 3D |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- history of Cushing's Disease
- aged : 18 - 60 years
- Biological remission of Cushing's disease for at least one year
- Affiliation to Social Security
- Informed consent signed by patient and investigator (at the latest the inclusion's day, before study's exams)
Key exclusion criteria (25 listed)
- Persistent hypercortisolism (even mild)
- Current treatment of hypercortisolism with drugs
- Obesity (BMI >30 kg/m²)
- Alcohol or drug addiction present or past
- Growth hormone deficit
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 |
|---|---|---|
| Virtual radial task in 3DThe virtual radial task is a labyrinth in 3D with twelve ways. The primary aim of our study is the evaluation of persistent cognitive impairments (hippocampal memory) according to the responses of participants after instructions to choose the right way in the labyrinth. | Device | Controls, Patients |
Primary outcome
Percentage of right answers at virtual radial task in 3D
Time frame: baseline
Comparison of right answers in patients cured of Cushing's disease and in controls.
6 secondary outcomes
General Quality of life
Time frame: baseline
Specific Quality of life for Cushing's Disease
Time frame: baseline
Number of participants with anxiety
Time frame: baseline
Number of participants with depression with MADRS
Time frame: baseline
Number of participants with depression with HADS
Time frame: baseline
Intensity of Cushing's syndrome
Time frame: baseline
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 4 Dec 2025.
- Results publication: PubMed 36004342Pupier E, Santos A, Etchamendy N, Lavielle A, Ferriere A, Marighetto A, Resmini E, Cota D, Webb SM, Tabarin A. Impaired quality of life, but not cognition, is linked to a history of chronic hypercortisolism in patients with Cushing's disease in remission. Front Endocrinol (Lausanne). 2022 Aug 8;13:934347. doi: 10.3389/fendo.2022.934347. eCollection 2022.
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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.
Antoine Tabarin, Pr principal investigator
Hôpital Haut Lévêque - Pessac (France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual radial task in 3D in people with Cushing's Disease, run by Institut National de la Santé Et de la Recherche Médicale, France 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 10 inclusion and 25 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 4 Dec 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?
Percentage of right answers at virtual radial task in 3D (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02603653, which also lists 1 linked publication.
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 4 Dec 2025.