Recruiting · registry statusFirst testing of ALN-SNCA in people
This early study checks whether the experimental medicine ALN-SNCA can be given safely and tolerated by adults with early Parkinson’s.
Testing a treatment or activity · Study reference: NCT07216066
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
Open the official registry record ↗Who can join?
Ages 50 years to 80 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
Key Inclusion Criteria:
1. Diagnosis of Parkinson's disease according to the Movement Disorder Society (MDS) criteria, as assessed by the investigator, with bradykinesia plus at least one of the other cardinal signs of Parkinson's disease (resting tremor, rigidity), without any other known or suspected cause of Parkinsonism
2. A diagnosis of Parkinson's disease for 4 years or less at the screening visit
3. Participant must meet one of the following criteria:
1. Currently not receiving any standard-of-care (SoC) therapy for Parkinson's disease, has not been on oral dopaminergic therapy (ie, levodopa, dopamine agonists, or Monoamine Oxidase B \[MAO-B\] inhibitors) prior to dosing, and is not anticipated to require SoC therapy for Parkinson's disease within approximately 6 months following dosing, or
2. Has been on a stable regimen of oral dopaminergic therapy for at least 3 months prior to dosing and is not anticipated to require dose adjustments within approximately 6 months following dosing
4. BMI ≤35 kg/m\^2 at time of screening visit
Key Exclusion Criteria:
1. Medical history indicating a Parkinsonian syndrome other than Parkinson's disease, as defined in the protocol
2. Clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease (excluding Parkinson's disease) that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant during study participation
3. Medical history of brain or spinal disease/injury that would interfere with the Lumbar Puncture (LP) procedure or CSF circulation, as defined in the protocol
4. Any contraindications to undergo a brain Magnetic Resonance Imaging (MRI)
5. An established allergy or intolerance to lidocaine anesthetic, as defined in the protocol
6. History of intolerance to Intrathecal (IT) injection(s)
7. Current history of bleeding diatheses that would increase risk of bleeding upon LP
8. Has undergone gene therapy, cell therapy or surgical treatment, including deep brain stimulation, for Parkinson's disease
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
Full study name & original research details
Official study 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
Short title used by the registry
First-in-Human Study of ALN-SNCA in Adult Participants With Early Parkinson's Disease (PD)
Original description
This study is researching an experimental drug called ALN-SNCA (called "study drug"). The study is focused on people with early Parkinson's disease, a disorder of the nervous system that affects movement. Parkinson's disease is caused by a gradual loss of nerve cells in the brain, especially those due to the harmful build-up of a protein called α-synuclein.
The aim of the study is to see if the study drug is safe and tolerated well enough to continue testing it in future studies and what side effects may happen from taking the study drug.
The study is looking at several other research questions, including:
* Whether the study drug can lower the level of α-synuclein protein in the Cerebrospinal Fluid (also referred to as "CSF", the fluid that surrounds the brain and spinal cord)
* How much study drug is in the blood, urine, and CSF at different times
Conditions reported: Parkinsons Disease
- Study type
- Interventional
- Interventions
- ALN-SNCA; Placebo
- Phases
- PHASE1
- Sponsor
- Regeneron Pharmaceuticals
- Start date reported by registry
- 2025-12-05 (actual)
Registry updated: 2026-09-21 · Status last verified by the registry submitter: 2026-09
Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Clinical Trials Administrator · 844-734-6643 · clinicaltrials@regeneron.com
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
The Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
RecruitingMontreal Neurological Institute and Hospital
Montreal, Quebec, Canada
RecruitingCenter for Human Drug Research
Leiden, South Holland, Netherlands
RecruitingThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.