Parkinson's Trial NCT05767151

Track early Parkinson disease progression

Trial ID
NCT05767151
Official Title
The Chinese DENOVO Parkinson's Disease Registry
Goal
Track early Parkinson disease progression
Status
RECRUITING
Sponsor
Xiangya Hospital of Central South University
Study Type
OBSERVATIONAL
Enrollment
300 participants
Conditions
Parkinson Disease

Summary For Families

The registry aims to map the early course of Parkinson's disease and find patterns or markers that could help with earlier diagnosis and better care down the road. It enrolls 300 people who are newly diagnosed and treatment naive, then collects standardized clinical assessments and follow-up data to see how symptoms and signs evolve over time. Eligible participants are 30 to 75 years old, diagnosed by MDS criteria with disease duration of two years or less, Hoehn-Yahr stage 2 or lower, not yet on antiparkinsonian drugs, and without cognitive impairment or other parkinsonism syndromes.

Locations

  • Xiangya Hospital of Central South University, Changsha, Hunan, China

Frequently Asked Questions

What is this trial testing?
This trial is studying an experimental treatment. The registry aims to map the early course of Parkinson's disease and find patterns or markers that could help with earlier diagnosis and better care down the road. It enrolls 300 people who are newly diagnosed and treatment naive, then collects standardized clinical assessments and follow-up data to see how symptoms and signs evolve over time. Eligible participants are 30 to 75 years old, diagnosed by MDS criteria with disease duration of two years or less, Hoehn-Yahr stage 2 or lower, not yet on antiparkinsonian drugs, and without cognitive impairment or other parkinsonism syndromes.
Who can participate?
Participants must be between 30 Years and 75 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
How long does the trial last?
This trial is estimated to last approximately 10 years.
Can I leave the trial if I change my mind?
Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
Can my spouse or care partner come with me to visits?
In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
Will I get a placebo in this trial?
This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
How many visits does this trial involve?
You will have study visits at baseline and at 12±1 months.
What procedures are involved in this trial?
Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive); Walking & movement tests (non-invasive); Thinking & memory tests (non-invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.

Related Reading

View on ClinicalTrials.gov