Alzheimer’s Prevention Study Dosed First Participant
The SPINOZA trial is testing if a daily medication can impact biological markers in people with preclinical Alzheimer’s.
Updated on Sept. 29, 2026 in Alzheimer’s
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NewAmsterdam Pharma has dosed the first participant in the SPINOZA clinical trial, which investigates the impact of obicetrapib on Alzheimer’s disease markers. This study focuses on 400 individuals in the preclinical stage of the condition.
Why it matters
The trial aims to determine if intervention can alter biological changes associated with the disease before symptoms appear. This research could shift the approach to Alzheimer’s from managing established symptoms to early-stage biological management.
The SPINOZA trial is a Phase 2b study enrolling 400 participants to receive 10 mg of obicetrapib or a placebo for 52 weeks. The trial measures changes in plasma p-tau217 levels, following prior biomarker analysis in the 1,535-patient BROADWAY trial that indicated a response in ApoE4 carriers.
The players
NewAmsterdam Pharma
A pharmaceutical company headquartered in the Netherlands and Florida that develops treatments for cardiometabolic and neurodegenerative diseases.
The details
Participants in the trial receive 10 mg of obicetrapib once daily or a placebo, with researchers stratifying individuals based on ApoE genotypes before randomization. The study specifically targets the change in plasma p-tau217, a protein associated with the biological progression of Alzheimer's. After the 52-week double-blind treatment period, eligible participants may continue into a 26-week open-label extension.
Timeline
March 2022: NewAmsterdam commenced the PREVAIL cardiovascular trial.
April 2024: NewAmsterdam completed enrollment for the PREVAIL trial.
September 29, 2026: The first participant was dosed in the SPINOZA trial.
Week 52: Primary efficacy endpoint measurement occurs.
Health Landscape
This research follows a growing trend in neurodegenerative medicine that shifts the focus toward managing biological markers in preclinical populations. The study extends the insights gained from the BROADWAY biomarker analysis to determine if early intervention can modify the disease trajectory.
The study is currently enrolling a specific patient population, and participants should discuss the potential risks and requirements of the 52-week trial with their primary physician. If you or a family member have concerns about preclinical markers, consult your doctor about relevant screenings.
The takeaway
This trial represents a shift toward early, biomarker-driven treatment strategies for Alzheimer's disease. Patients and their families should follow updates on p-tau217 research and discuss any participation in clinical trials with their neurologist.
Further reading
For more on the current landscape of research, visit the United States Alzheimer’s section.
More information
For more information, visit the SPINOZA trial information portal.
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Should pharmaceutical companies prioritize developing preventative treatments for Alzheimer's disease over other medical research?
