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NCT01925196 · ClinicalTrials.gov registry record
Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 50
- Enrollment target
NCT01925196 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 50 participants.
The verdict
NCT01925196 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
Background: \- Some people have a mutation in the C9ORF72 gene that causes amyotrophic lateral sclerosis (ALS) or frontotemporal dementia (FTD). The mutation causes a small piece of DNA to repeat itself thousands of times. The C9ORF gene mutation mostly occurs in families. In those families, some persons have ALS and others have FTD. Occasionally the C9ORF gene mutation occurs in persons without a family history. Researchers want to understand how this gene causes different diseases. They will study how symptoms caused by the C9ORF gene develop and change over time. They will measure symptoms that occur in ALS and in FTD. In particular, they will measure strength, ability to move, thinking, and memory. They will also see if other tests are associated with progression of disease. These tests, called biomarkers, may help detect or measure C9ORF72 disease in the future. Objectives: \- To understand how symptoms change over time in people with mutations in a gene called C9ORF72, which causes ALS and FTD. Eligibility: \- Adults over age 18 who have this genetic mutation Design: * Participants will have up to 4 in-person visits and 3 telephone interviews over 3 years. Each in-person visit may take place over several days. They may be either inpatient or outpatient visits. * At each visit, participants will undergo a series of brain, language, and behavior tests. These will include: * Magnetic resonance imaging (MRI) of the brain. This uses magnets, radio waves, and computers to produce detailed pictures of the brain. * Collecting spinal fluid. The clinician will make the participant s back numb and then insert a needle to collect fluid. \<TAB\>- Blood samples will be taken. \<TAB\>- Participants will be asked to perform several language and movement tests. \<TAB\>- Small skin samples will be taken on one visit \- Between visits, participants will answer questions about their health over the phone 3 times.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-09-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01925196
The ClinicalTrials.gov registry entry for NCT01925196 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01925196 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01925196 about?
NCT01925196 is a clinical study titled "Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation". Background: \- Some people have a mutation in the C9ORF72 gene that causes amyotrophic lateral sclerosis (ALS) or frontotemporal dementia (FTD). The mutation causes a small piece of DNA to repeat itself thousands of times. The C9ORF gene mutation mostly occurs in families. In those families, some p...
What is the current status of trial NCT01925196?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2013-09-30.
Who is sponsoring clinical trial NCT01925196?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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