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New treatment option for Parkinsons Disease
Official title First-in-Human Study of ALN-SNCA in Adult Participants With Early Parkinson's Disease (PD)
ClinicalTrials.gov ID: NCT07216066
What this study is testing
What is ALN-SNCA?
ALN-SNCA is an investigational medicine, being studied as a potential treatment for parkinsons disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- Diagnosis of Parkinson's disease according to the Movement Disorder Society (MDS) criteria, as assessed by the investigator, with bradykinesia plus...
- A diagnosis of Parkinson's disease for 4 years or less at the screening visit
- Participant must meet one of the following criteria:
- Currently not receiving any standard-of-care (SoC) therapy for Parkinson's disease, has not been on oral dopaminergic therapy (ie, levodopa, dopamine...
- 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...
You likely can't join if
- Medical history indicating a Parkinsonian syndrome other than Parkinson's disease, as defined in the protocol
- Clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease...
- Medical history of brain or spinal disease/injury that would interfere with the Lumbar Puncture (LP) procedure or CSF circulation, as defined in the...
- Any contraindications to undergo a brain Magnetic Resonance Imaging (MRI)
- An established allergy or intolerance to lidocaine anesthetic, as defined in the protocol
- History of intolerance to Intrathecal (IT) injection(s)
See the full eligibility criteria
- 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...
- A diagnosis of Parkinson's disease for 4 years or less at the screening visit
- Participant must meet one of the following criteria:
- 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...
- 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
- BMI ≤35 kg/m\^2 at time of screening visit Key
- Medical history indicating a Parkinsonian syndrome other than Parkinson's disease, as defined in the protocol
- Clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease (excluding Parkinson's disease) that, as assessed by the investigator...
- 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
- Any contraindications to undergo a brain Magnetic Resonance Imaging (MRI)
- An established allergy or intolerance to lidocaine anesthetic, as defined in the protocol
- History of intolerance to Intrathecal (IT) injection(s)
- Current history of bleeding diatheses that would increase risk of bleeding upon LP
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
- Leiden, South Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada; Leiden, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.