Assessment of Persistent Cognitive Impairment After Cure of Cushing's Disease (NCT02603653) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Persistent Cognitive Impairment After Cure of Cushing's Disease
France30 participantsStarted 2016-02-04
Plain-language 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. 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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)
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)
Exclusion Criteria:
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
* 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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of right answers at virtual radial task in 3D
Timeframe: baseline
Trial details
NCT IDNCT02603653
SponsorInstitut National de la Santé Et de la Recherche Médicale, France