Obicetrapib vs. placebo in people at risk for preclinical Alzheimer’s disease
Official title: A Phase 2b, Randomized, Double Blind, Placebo Controlled, Parallel Group Trial to Assess the Efficacy and Safety of Obicetrapib in Participants With Preclinical Alzheimer's Disease (SPINOZA Trial)
Run by NewAmsterdam Pharma · NCT07794670 · Data updated 2026-11-12
This study tests whether Obicetrapib can help people who may be at risk for preclinical Alzheimer's disease compare to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | NewAmsterdam Pharma Industry-sponsored |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | September 2028 |
| Study ends | May 2029 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT07794670 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with preclinical Alzheimer’s disease and APOE genotype criteria defined by the protocol.
✕Probably not a fit
Individuals whose APOE genotype or other criteria do not align with the protocol may not experience a benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2, randomized trial compares Obicetrapib 10 mg to matching placebo in adults identified as potentially at risk for preclinical Alzheimer’s disease. Eligible participants are adults with preclinical AD and specific APOE genotype criteria. The study uses a double-arm design to evaluate safety and potential signals of effect on biomarkers related to preclinical AD, including ptau 217. Investigators at K2 Medical Research in Nashville, TN, conduct the trial with NewAmsterdam Pharma as lead sponsor. Outcomes focus on biomarker changes and other safety data to inform future development.
Why it matters
Potential benefit: If successful, participants might experience biomarker changes that support delaying or reducing progression toward symptomatic Alzheimer’s disease.
How similar studies have gone: Previous studies in similar preclinical AD populations have shown mixed results, making this trial an important step to determine potential benefit of Obicetrapib in this stage.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * participants with preclinical AD Exclusion Criteria: * APOE genotype not meeting protocol-defined eligibility criteria
Where it's running
-
K2 Medical Research
Nashville, Tennessee, United States Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Tau vaccine AV-1980R in preclinical Alzheimer’s disease
A Phase 1 study tests a tau-targeting vaccine (AV-1980R) to see if it is safe, tolerable, and can provoke an immune response in older adults who show biomarkers of preclinical Alzheimer’s disease but no cognitive impairment.
-
Alzheimer’s Tau Platform: a Master Protocol
This platform study tests tau-directed therapies, alone or with donanemab, in adults 50–80 with late preclinical or early prodromal Alzheimer’s disease to see if they reduce brain tau and slow disease progression.
-
DUVAX: a first-in-human vaccine for amyloid and tau targets in adults 40-65
A first-in-human vaccine called DUVAX is tested in healthy adults to see if it's safe and whether it triggers an immune response against Alzheimer’s-related proteins.
-
Using brain stimulation to improve memory and motivation in older adults
This study is testing if a type of brain stimulation can help improve memory and motivation in older adults, including those showing early signs of Alzheimer's disease.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.