ALN-SNCA for Parkinson's (NCT07216066)
Reduce harmful brain protein levels
- Trial ID
- NCT07216066
- Official Title
- First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Intrathecally Administered ALN-SNCA in Participants With Early Parkinson's Disease
- Goal
- Reduce harmful brain protein levels
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Regeneron Pharmaceuticals
- Study Type
- INTERVENTIONAL
- Enrollment
- 46 participants
- Conditions
- Parkinsons Disease
- Interventions
- ALN-SNCA, Placebo
Summary For Families
A team is testing an experimental medicine called ALN-SNCA in people with early Parkinson's to see if it is safe, well tolerated, and whether it can lower levels of the harmful protein alpha-synuclein in the spinal fluid and possibly slow how symptoms progress. The medicine is given as an injection into the fluid around the spinal cord, and the study will also measure how much drug shows up in blood, urine, and spinal fluid over time while watching for side effects. They want people aged 50 to 80 diagnosed within the last four years who are either not yet taking levodopa or other oral Parkinson's drugs, or who have been on a stable dose for at least three months, and who can safely have the spinal fluid injection and brain imaging.
Locations
- Montreal Neurological Institute and Hospital, Montreal, Quebec, Canada
- Center for Human Drug Research, Leiden, South Holland, Netherlands
Frequently Asked Questions
- What is this trial testing?
- This trial is studying ALN-SNCA. A team is testing an experimental medicine called ALN-SNCA in people with early Parkinson's to see if it is safe, well tolerated, and whether it can lower levels of the harmful protein alpha-synuclein in the spinal fluid and possibly slow how symptoms progress. The medicine is given as an injection into the fluid around the spinal cord, and the study will also measure how much drug shows up in blood, urine, and spinal fluid over time while watching for side effects. They want people aged 50 to 80 diagnosed within the last four years who are either not yet taking levodopa or other oral Parkinson's drugs, or who have been on a stable dose for at least three months, and who can safely have the spinal fluid injection and brain imaging.
- Who can participate?
- Participants must be between 50 Years and 80 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 1 trial is estimated to last approximately 3 years and 6 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive). Confirm the full schedule with the study coordinator.