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Natural History Study of Synucleinopathies
NCT01799915 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01799915 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Other, Massachusetts, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT01799915?
This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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