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NCT05854433 · ClinicalTrials.gov registry record

Brain Structure and Clinical Endpoints in Myotonic Dystrophy Type 2

A clinical trial of Myotonic Dystrophy Type 1 and Myotonic Dystrophy Type 2, sponsored by Wake Forest University Health Sciences.

Recruiting
Registry status
100
Enrollment target
1
Study location

NCT05854433 is a study of Myotonic Dystrophy Type 1 and Myotonic Dystrophy Type 2 that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 100 participants, below the 1,052-participant average among 3 other Myotonic Dystrophy Type 1 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05854433, a study of Myotonic Dystrophy Type 1 and Myotonic Dystrophy Type 2, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.

RECRUITING
Registry status
100 participants
Enrollment target
1
Study location

Study Summary

Nearly two-third of patients with myotonic dystrophy type 2 (DM2) report that impaired cognition is among the most disabling symptoms and deeply affects their quality of life. Yet, relatively little is known about how DM2 affects brain structure and cognitive function as brain imaging studies in DM2 are extremely limited. This is a prospective, cross-sectional study of brain structure and function on cognitive and motor performance in patients with DM2 \& DM1 compared to healthy controls. All participants will undergo magnetic resonance imaging (MRI) to evaluate brain structure and white matter integrity, a comprehensive battery of cognitive and motor measures, self-reported questionnaires, and blood collection for brain-based biomarker analysis. A subset of participants will undergo lumbar puncture for cerebrospinal fluid (CSF) collection for additional biomarker analysis and validation. This work is critical to inform the development of rigorous clinical trial designs and plan for a longitudinal study to evaluate MRI measures as imaging biomarkers of disease progression and therapeutic response in DM2 \& DM1.

Conditions Studied

Myotonic Dystrophy Type 1 Myotonic Dystrophy Type 2

Interventions

  • OTHER Non-interventional study

Study Locations (1)

North Carolina

  • Wake Forest University Health Sciences - Winston-Salem

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-04-26
Est. Completion 2027-06

Sponsor

Wake Forest University Health Sciences

1,140 total trials

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What the Registry Record Tells You About NCT05854433

The ClinicalTrials.gov registry entry for NCT05854433 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,052-participant average among 3 other Myotonic Dystrophy Type 1 trials with a reported enrollment target (90% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Myotonic Dystrophy Type 1 appearing as the primary indexed condition, and to 1 intervention - of which Non-interventional study is the first listed.

NCT05854433 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT05854433 about?

NCT05854433 is a clinical study titled "Brain Structure and Clinical Endpoints in Myotonic Dystrophy Type 2". Nearly two-third of patients with myotonic dystrophy type 2 (DM2) report that impaired cognition is among the most disabling symptoms and deeply affects their quality of life. Yet, relatively little is known about how DM2 affects brain structure and cognitive function as brain imaging studies in DM2...

What is the current status of trial NCT05854433?

This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2023-04-26. Estimated completion is 2027-06.

What conditions does trial NCT05854433 study?

This clinical trial studies the following conditions: Myotonic Dystrophy Type 1, Myotonic Dystrophy Type 2.

What interventions are being tested in trial NCT05854433?

The interventions under investigation include: Non-interventional study (OTHER).

Who is sponsoring clinical trial NCT05854433?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05854433 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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