Assessment of Persistent Cognitive Impairment After Cure of Cushing's Disease
MEMOCUSH
Cognitive Sequels of Cushing Syndrome
2 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedStudy Start
First participant enrolled
February 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2017
CompletedDecember 4, 2025
November 1, 2015
1 year
November 3, 2015
November 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
General Quality of life
baseline
Specific Quality of life for Cushing's Disease
baseline
Number of participants with anxiety
baseline
Number of participants with depression with MADRS
baseline
Number of participants with depression with HADS
baseline
- +1 more secondary outcomes
Study Arms (2)
Patients
EXPERIMENTALVirtual radial task in 3D
Controls
EXPERIMENTALVirtual radial task in 3D
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- For controls :
- People aged 18 to 60 years matched to patients for age, sex and educational level
- Affiliation to Social Security
You may not qualify if:
- 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 :
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital du Haut-Lévêque
Pessac, 33604, France
Related Publications (1)
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.
PMID: 36004342RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antoine Tabarin, Pr
Hôpital Haut Lévêque - Pessac (France)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2015
First Posted
November 13, 2015
Study Start
February 4, 2016
Primary Completion
February 12, 2017
Study Completion
August 3, 2017
Last Updated
December 4, 2025
Record last verified: 2015-11