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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 1 year and 11 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.