- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04656210
Myotonic Dystrophy - Vascular and Cognition (MD-VASCOG)
Links Between Diabetes and Cognitive Impairment in Myotonic Dystrophy Type 1 : a Non-conventional MRI Study
The cognitive disorders of adult forms of myotonic dystrophies type 1 are heterogeneous (impairment of executive functions, visio construction and theory of the mind, which can progress to the stage of dementia). Nevertheless, patients have very different degrees of cognitive impairment. Expansion of CTG triplets disrupts the alternative splicing of mRNAs of various proteins, including the insulin receptor and Tau protein. Type 2 diabetes, associated with peripheral insulin resistance, is therefore common in this pathology.
Type 2 diabetes,could to explain the cognitive impairment of patients, through the accelerated development of brain lesions (especially tauopathy and cerebral atrophy).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Céline TARD, MD
- Phone Number: 0320445962
- Email: celine.tard@chru-lille.fr
Study Locations
-
-
-
Lille, France, 59037
- Recruiting
- Hôpital Roger Salengro, CHU Lille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Molecularly proven type 1 myotonic dystrophy
- Voluntary, having given informed consent
- Socially insured patient
- Patient willing to comply with all study procedures and duration (3 hours + MRI 35 minutes)
- Patient insured under the French social security system
- Signed consent form
Exclusion Criteria:
- Neurological history other than neuropathy: epilepsy, stroke, dementia
- Pregnancy or breastfeeding or woman of childbearing age without effective contraception (a pregnancy test will be done)
- Contra indication to MRI
- Person under guardianship or curators
- Persons of full age deprived of their liberties by a judicial or administrative decision
- Major comorbidity considered as a contraindication by the investigator (cancer, unstable angina, etc.).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1: MD type 1 normal
patients with type 1 myotonic dystrophy with normal carbohydrate tolerance
|
Non conventional MRI (35 minutes)
Standardized and quantified neuropsychological assessment
|
Group 2: MD type 1 Diabetes
patients with type 1 myotonic dystrophy with diabetes.
Patients with carbohydrate intolerance ("pre-diabetes") who became diabetic at 3 years of age will be divided into Group 2.
|
Non conventional MRI (35 minutes)
Standardized and quantified neuropsychological assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Atrophy difference based on two cerebral MRI volumetries
Time Frame: at 4 years
|
difference between initial MRI and 4-year MRI
|
at 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in scores at 4-year neuropsychological assessment of inclusion
Time Frame: At baseline at 4 years
|
difference between initial assessment and 4-year assessment
|
At baseline at 4 years
|
changes in tau biomarkers in blood at 4 years of inclusion
Time Frame: At baseline at 4 years
|
difference between initial and 4-year dosing
|
At baseline at 4 years
|
changes in amyloid biomarkers in blood at 4 years of inclusion
Time Frame: At baseline at 4 years
|
difference between initial and 4-year dosing
|
At baseline at 4 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018_31
- 2019-A00086-51 (Other Identifier: ID-RCB number, ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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