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NCT01799915 · ClinicalTrials.gov registry record
Natural History Study of Synucleinopathies
A clinical trial of Parkinson Disease and Multiple System Atrophy, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- 800
- Enrollment target
- 8
- Study locations
NCT01799915 is a study of Parkinson Disease and Multiple System Atrophy that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 800 participants, below the 5,324-participant average among 297 other Parkinson Disease trials with a reported enrollment target (85% lower). The trial reports 8 study locations across 6 states.
The verdict
NCT01799915, a study of Parkinson Disease and Multiple System Atrophy, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- 800 participants
- Enrollment target
- 8
- Study locations
Study Summary
Synucleinopathies are a group of rare diseases associated with worsening neurological deficits and the abnormal accumulation of the protein α-synuclein in the nervous system. Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present clinically with slowness of movement, coordination difficulties or mild cognitive impairment. Development of these features indicates that abnormal alpha-synuclein deposits have destroyed key areas of the brain involved in the control of movement or cognition. Patients with synucleinopathies and signs of CNS-deficits are frequently diagnosed with Parkinson disease (PD), dementia with Lewy bodies (DLB) or multiple system atrophy (MSA). However, accumulation of alpha-synuclein and death of nerve cells can also begin outside the brain in the autonomic nerves. In such cases, syncucleinopathies present first with symptoms of autonomic impairment (unexplained constipation, urinary difficulties, and sexual dysfunction). In rare cases, hypotension on standing (a disorder known as orthostatic hypotension) may be the only clinical finding. This "pre-motor" autonomic stage suggests that the disease process may not yet have spread to the brain. After a variable period of time, but usually within 5-years, most patients with abnormally low blood pressure on standing develop cognitive or motor abnormalities. This stepwise evolution indicates that the disease spreads from the body to the brain. Another indication of this spread is that acting out dreams (i.e., REM sleep behavior disorder, RBD) a problem that occurs when the lower part of the brain is affected, may also be the first noticeable sign of Parkinson disease. The purpose of this study is to document the clinical features and biological markers of patients with synucleinopathies and better understand how these disorders evolve over time. The study will involve following patients diagnosed with a synucleinopathy (PD/DLB and MSA) and those believed to be in the
Conditions Studied
Study Locations (8)
Other
- FLENI - Fundación para la Lucha contras las Enfermedades Neurológicas - Buenos Aires
- Seoul National University Hospital - Seoul
- BioCruces Research Institute - Hospital Universitario de Cruces - Bilbao
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
New York
- NYU Medical Center - New York
Tennessee
- Vanderbilt Univeristy - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2011-06 |
| Est. Completion | 2026-12-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01799915
The ClinicalTrials.gov registry entry for NCT01799915 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,324-participant average among 297 other Parkinson Disease trials with a reported enrollment target (85% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 0 interventions.
NCT01799915 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Other, Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT01799915 about?
NCT01799915 is a clinical study titled "Natural History Study of Synucleinopathies". Synucleinopathies are a group of rare diseases associated with worsening neurological deficits and the abnormal accumulation of the protein α-synuclein in the nervous system. Onset is usually in late adulthood at age 50 or older. Usually, synucleinopathies present clinically with slowness of movemen...
What is the current status of trial NCT01799915?
This trial is currently recruiting. The enrollment target is 800 participants. The study started on 2011-06. Estimated completion is 2026-12-30.
What conditions does trial NCT01799915 study?
This clinical trial studies the following conditions: Parkinson Disease, Multiple System Atrophy, Dementia With Lewy Bodies, Pure Autonomic Failure, REM Sleep Behavior Disorder.
Who is sponsoring clinical trial NCT01799915?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01799915 being conducted?
This trial has 8 study locations across Massachusetts, Michigan, Minnesota, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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