Placebo for Parkinson's (NCT07207057)
Slow Parkinson progression with telmisartan
- Trial ID
- NCT07207057
- Official Title
- Edmond J Safra, Accelerating Clinical Trials in Parkinson's Disease (EJS ACT-PD) - a Multi-arm Multi-stage Platform Trial for Potential Disease Modifying Approaches.
- Goal
- Slow Parkinson progression with telmisartan
- Phase
- PHASE3
- Status
- RECRUITING
- Sponsor
- University College, London
- Study Type
- INTERVENTIONAL
- Enrollment
- 1200 participants
- Conditions
- Parkinsons Disease (PD)
- Interventions
- Placebo, Telmisartan, Terazosin (Hytrin)
Summary For Families
The goal is to see if two repurposed drugs can slow Parkinson's progression and protect neurons, offering possible disease modification rather than only treating symptoms. Telmisartan blocks angiotensin II type 1 receptors to lower blood pressure and may reduce brain inflammation and oxidative stress, so it would be taken alongside usual Parkinson's medicines like levodopa with monitoring of blood pressure, potassium and kidney function. Terazosin is an alpha-1 blocker that also activates the enzyme PGK1 to boost cellular energy and ATP in neurons, which could make cells more resilient; it can cause dizziness or low blood pressure so people on other alpha blockers or with symptomatic hypotension are excluded. The trial is enrolling about 1,200 adults aged 30 and up with neurologist-diagnosed Parkinson's who have been on levodopa or a dopamine agonist for at least two months, excluding those with dementia, certain genetic forms, recent experimental drug exposure, serious heart or kidney disease, problematic low blood pressure, or pregnancy.
Locations
- UCLH, London, United Kingdom
- Clinical Ageing Research Unit, Newcastle, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Placebo. The goal is to see if two repurposed drugs can slow Parkinson's progression and protect neurons, offering possible disease modification rather than only treating symptoms. Telmisartan blocks angiotensin II type 1 receptors to lower blood pressure and may reduce brain inflammation and oxidative stress, so it would be taken alongside usual Parkinson's medicines like levodopa with monitoring of blood pressure, potassium and kidney function. Terazosin is an alpha-1 blocker that also activates the enzyme PGK1 to boost cellular energy and ATP in neurons, which could make cells more resilient; it can cause dizziness or low blood pressure so people on other alpha blockers or with symptomatic hypotension are excluded. The trial is enrolling about 1,200 adults aged 30 and up with neurologist-diagnosed Parkinson's who have been on levodopa or a dopamine agonist for at least two months, excluding those with dementia, certain genetic forms, recent experimental drug exposure, serious heart or kidney disease, problematic low blood pressure, or pregnancy.
- Who can participate?
- Participants must be at least 30 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 3 trial is estimated to last approximately 5 years and 8 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 3 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 3 chance (roughly 33%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- An in-person screening visit, then remote visits at 3 months, 6 months, and every 6 months thereafter, with follow-up for up to 36 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.
- Is there a medication washout in this trial?
- Yes — for participants being re-randomised there is a required washout: a 26-week washout from last dose of IMP before screening (which can be reduced to 6 weeks if the IMP was ineffective), or a 6-week washout if re-randomised following treatment arm termination due to lack of activity.