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Active, Not Recruiting

NCT Number: NCT04656210

Myotonic Dystrophy - Vascular and Cognition

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Myotonic Dystrophy 1 Carbohydrate Intolerance Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Diabetes Mellitus Endocrine System Diseases Genetic Diseases, Inborn Glucose Metabolism Disorders Glucose-Galactose Malabsorption Heredodegenerative Disorders, Nervous System Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Musculoskeletal Diseases Myotonic Disorders Myotonic Dystrophy Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Tauopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

MRI

Radiation

Non conventional MRI (35 minutes)

neuropsychological tests

Other

Standardized and quantified neuropsychological assessment

Primary outcomes

  1. Atrophy difference based on two cerebral MRI volumetries

    Time frame: at 4 years

    difference between initial MRI and 4-year MRI

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Links Between Diabetes and Cognitive Impairment in Myotonic Dystrophy Type 1 : a Non-conventional MRI Study

Acronym: DM-VASCOG

Important dates

Study start
2021
Primary completion
2024
Study completion
2029
First posted
Dec 7, 2020
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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