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Path to Prevention is a platform, phase 2 trial that will investigate the safety and efficacy of investigational interventions in patients neuronal α-synuclein disease stage 2B.
Tanya Simuni, MD, FAAN
(Credit: Northwestern University Feinberg School of Medicine)
At the 2024 International Congress of Parkinson’s Disease and Movement Disorders, held September 27 to October 1, in Philadelphia, Pennsylvania, investigators provided a new report on the study design and timeline of the Path to Prevention (P2P) Therapeutics platform trial targeting patients with neuronal α-synuclein disease (NSD) stage 2B.1
In the presented update, investigators reported that the final selection of the first 2 interventions will be presented from more than 15 industry submitted applications and that enrollment for the trial with these 2 first regimens is planned for 2025. Presented by lead author Tanya Simuni, MD, FAAN, the director of Parkinson's Disease and Movement Disorders Center at Northwestern University Feinberg School of Medicine, authors noted that these new research endeavors could add participants from Parkinson's Progression Markers Initiative (PPMI) as potentially qualified participants.
P2P is a platform, randomized double blind multi-center, multi-regimen phase 2 trial that will assess the safety and early efficacy of investigational therapies among participants with NSD stage 2B. Authors noted that P2P is a trial with a single Master Protocol that dictates the conduct of the study and regimen specific subprotocols that outline intervention specific aspects for each arm. Researchers also noted that participants eligible for the trial will be recruited from the PPMI participants, according to NSD stage 2B criteria.
The multiple primary end points of the study include dopamine transporter imaging, as measured by the rate of progression in the mean striatum Specific Binding Ratio, and rate of progression on the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score. Additionally, secondary end points of the trial include safety, tolerability, and feasibility. Authors reported that the P2P will have various exploratory clinical, including digital, and biomarker measures. Participants will first be randomized by researchers in an equal manner in all of the regimen-specific subprotocols for which they are each eligible for.
Following the randomization to a specific subprotocol, investigators will randomize participants to an active arm or placebo, with 125 patients per arm, in a K:1 ratio with K denoting the number of active interventions. The duration of the intervention will last for at least 24 months, until the last patient in that regimen has completed 24 months. Authors highlighted that the trial is 85% powered to identify a slowing in either of the primary end points for each regimen, assuming a 40% slowing in either end point.
Studies defined NSD as the presence of α-synuclein pathology, specifically dopamine dysfunction, and stage dependent motor and non-motor clinical manifestations and related to functional impairment. These patients diagnosed with the condition were previously clinically defined as Parkinson disease, dementia with Lewy bodies and prodromal. Authors of the presented study at MDS 2024 noted that this trial is “nested” in the PPMI and sponsored by the Michael J. Fox Foundation for Parkinson's Research.
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