Assessment of Persistent Cognitive Impairment After Cure of Cushing's Disease

Cushing's Disease Clinical Trial

— MEMOCUSH  

Official title:

Cognitive Sequels of Cushing Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02603653
• Other study ID #: C15-02
• Secondary ID: IDRCB
• Status: Not yet recruiting
• Phase: N/A
• First received: November 3, 2015
• Last updated: November 10, 2015
• Start date: November 2015
• Est. completion date: May 2017

Study information

• Verified date: November 2015
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Antoine Tabarin, Pr
• Email: antoine.tabarin[@]chu-bordeaux.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• ACTH-Secreting Pituitary Adenoma
• Cushing's Disease
• Pituitary ACTH Hypersecretion

Intervention

Device:
• Virtual radial task in 3D
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.

Locations

Country	Name	City	State
France	Hôpital du Haut-Lévêque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of right answers at virtual radial task in 3D	Comparison of right answers in patients cured of Cushing's disease and in controls.	baseline	Yes
Secondary	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)	baseline	Yes
Secondary	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	baseline	Yes
Secondary	Number of participants with anxiety	Evaluation of anxiety in the two groups with Hospital Anxiety and Depression Scale (HADS) scale (questionnaire)	baseline	Yes
Secondary	Number of participants with depression with MADRS	Evaluation of depression in the two groups with Montgomery and Asberg Depression Rating Scale (MADRS) (questionnaire)	baseline	Yes
Secondary	Number of participants with depression with HADS	Evaluation of depression in the two groups with Hospital Anxiety and Depression Scale (HADS) scale (questionnaire)	baseline	Yes
Secondary	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.	baseline	Yes