Tenofovir Disoproxil Fumarate for Parkinson's (NCT06356662)
Tenofovir slows Parkinson disease progression
- Trial ID
- NCT06356662
- Official Title
- Efficacy and Safety of Tenofovir Disoproxil Fumarate in the Treatment of Parkinson's Disease
- Goal
- Tenofovir slows Parkinson disease progression
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease
- Interventions
- Tenofovir Disoproxil Fumarate
Summary For Families
Researchers are testing whether the antiviral tenofovir disoproxil fumarate can slow or modify Parkinson's by reducing brain inflammation or other processes that may contribute to dopamine neuron damage. In this Phase 1 trial tenofovir, a nucleotide reverse transcriptase inhibitor that blocks viral replication and may lower systemic inflammation, is being repurposed as an oral treatment and will be closely monitored for safety, especially kidney and liver function. No direct interaction with levodopa is expected, but the study will watch for any medication interactions or side effects. The trial enrolls adults 18 to 65 with early-to-mid Parkinson's (Hoehn and Yahr 1 to 2.5) and normal cognition (MMSE ≥24), excluding people with chronic hepatitis B or HIV, abnormal liver or kidney tests, prior brain surgery like DBS, major psychiatric or other serious medical conditions, pregnancy, or allergy to the drug.
Locations
- Guohua Zhao, Hangzhou, Zhejiang, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Tenofovir Disoproxil Fumarate. Researchers are testing whether the antiviral tenofovir disoproxil fumarate can slow or modify Parkinson's by reducing brain inflammation or other processes that may contribute to dopamine neuron damage. In this Phase 1 trial tenofovir, a nucleotide reverse transcriptase inhibitor that blocks viral replication and may lower systemic inflammation, is being repurposed as an oral treatment and will be closely monitored for safety, especially kidney and liver function. No direct interaction with levodopa is expected, but the study will watch for any medication interactions or side effects. The trial enrolls adults 18 to 65 with early-to-mid Parkinson's (Hoehn and Yahr 1 to 2.5) and normal cognition (MMSE ≥24), excluding people with chronic hepatitis B or HIV, abnormal liver or kidney tests, prior brain surgery like DBS, major psychiatric or other serious medical conditions, pregnancy, or allergy to the drug.
- Who can participate?
- Participants must be between 18 Years and 65 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 Phase 1 trial is estimated to last approximately 1 year and 11 months.
- 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 trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.