Follows people with brain-related synucleinopathies over time to track how they change
Follows adults with Parkinson, Lewy body dementia, MSA, or early autonomic symptoms over time.
Key facts
- Who runs it
- NYU Langone Health
- Where
- Buenos Aires, ArgentinaSee the siteAlso in 3 other countries, 7 sites
- Trial code
- Registry title
- Natural History Study of Synucleinopathies
- Status
- Recruiting
- People taking part
- 800 people, planned
- Started
- Jun 2011
- Expected to end
- 30 Dec 2026
- Type of study
- Observational, 5 groups
- Record updated
- 10 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults sent to a study centre because they feel dizzy or lightheaded when standing. It follows people with synucleinopathy diseases, or who may be in an early stage, over time.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- People with dizziness or lightheadedness when standing that goes away when lying down (orthostatic intolerance). The study covers synucleinopathies such as Parkinson disease, dementia with Lewy bodies, multiple system atrophy and early stages with only autonomic problems or REM sleep behavior disorder.
Main reasons for not taking part
- Diabetes
- Congestive heart failure
- Lupus or other collagen vascular disease
- Another illness thought to cause the dizziness on standing
- Low blood pressure on standing caused by drugs such as alpha-blockers, diuretics or tricyclic antidepressants
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Both male and female patients will be included
- Aged 18 or over
- Referred to any of the participating consortium sites with orthostatic intolerance, defined as symptoms of dizziness or lightheadedness in the standing position that disappear when supine
Who cannot take part
- Drug-induced orthostatic hypotension (i.e., the use of alpha-blockers, diuretics, tricyclic antidepressants or others thought by the investigator to play an important role in the patient's orthostatic hypotension)
- Diabetes according to the American Diabetes Association criteria
- Congestive heart failure
- Lupus or other collagen vascular disease
- Systemic illness thought to be responsible for the orthostatic intolerance
- Isolated vasovagal syncope
- Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Where in Argentina
Also in 3 other countries, 7 sites
- FLENI - Fundación para la Lucha contras las Enfermedades NeurológicasBuenos Aires, ArgentinaContact: Malco RossiTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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 "pre-motor" stage (with isolated autonomic impairment and/or RBD). Through a careful series of follow-up visits to participating Centers, we will focus on finding biological clues that predict which patients will develop motor/cognitive problems and which ones have the resilience to keep the disease at bay preventing spread to the brain. We will also define the natural history of MSA - the most aggressive of the synucleinopathies.
The 5 groups in the trial
- REM sleep behavior disorder, RBD
Patients that have rapid eye movement sleep behavior disorder.
- multiple system atrophy
is a neurodegenerative disorder charaterized by abnormal alpha-synuclein deposition in the cytoplasm of oligodendroglial cells in the CNS, and typically sparing peripheral autonomic nerves.
- Pure Autonomic failure
A neurodegenerative disorder characterized by loss of peripheral noradrenergic fibers, with low levels of plasma norepinephine.
- Parkinson disease
A degenerative disorder of the central nervous system that leads to termors, difficulty walking, movement and coordination.
- Dementia with Lewy bodies
A neurodegenerative disorder similar to PAF and PD with the accumulation of Alpha-synuclein in the CNS however DLB patients develop dementia.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Natural History Study of Synucleinopathies
- Plain-language title
- Follows people with brain-related synucleinopathies over time to track how they changeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 10 June 2026