> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/randomized-study-to-evaluate-the-effect-of-obicetrapib-in-d88ee2d1-fe26-4e8d-82d7-acc732c08093 > Record changed: 2026-11-04 # Randomized Study to Evaluate the Effect of Obicetrapib in Participants With Preclinical Alzheimer's Disease NCT07794670 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) Participants 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) Lead sponsor NewAmsterdam Pharma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) Start date 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) ## Title and summary **Summary** A study evaluating Obicetrapib in adults potentially at risk for Preclinical Alzheimer's Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Acronym** SPINOZA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Short title** Randomized Study to Evaluate the Effect of Obicetrapib in Participants With Preclinical Alzheimer's Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) ## Dates **Completion date** 2029-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **First posted** 2026-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Registry last updated** 2026-09-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Primary completion date** 2028-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Start date** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) ## Size and sites **Participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Planned participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Lead sponsor** NewAmsterdam Pharma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) ## Identifiers **Registry ID** NCT07794670 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **ClinicalTrials.gov ID** NCT07794670 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) ## Outcomes ### Primary outcomes 1. Change from Baseline to Week 52 in ptau 217 Timeframe: Baseline, Week 52 ### Secondary outcomes 1. Change from Baseline to Week 52 in Alzheimer's disease related biomarker Amyloid β 42/Amyloid β 40 ratio Timeframe: Baseline, Week 52 Measure changes in proteins that can be early signs of Alzheimer's disease. 2. Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42 ratio Timeframe: Baseline, Week 52 Measure changes in two proteins that can be early signs of Alzheimer's disease. 3. Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42/Amyloid β40 ratio Timeframe: Baseline, Week 52 Measure changes in three proteins that can be early signs of Alzheimer's disease. 4. Change from Baseline to Week 52 in Alzheimer's disease related biomarker BD-tau Timeframe: Baseline, Week 52 Measures a protein released from brain cells that can be early signs of Alzheimer's disease. 5. Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score Timeframe: Baseline, Week 52 The PACC5 is a standardized set of tests used to measure memory and thinking skills. It is designed to find small changes in memory and thinking that may happen before symptoms of Alzheimer's disease appear. The composite score is derived from standardized scores on five assessments that measure different skills: memory, delayed memory, overall thinking, speed of thinking, and language skills. Higher scores mean better memory and thinking performance. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 55 Years **Maximum age** 85 Years **Healthy volunteers** No ### Inclusion criteria - participants with preclinical AD ### Exclusion criteria - APOE genotype not meeting protocol-defined eligibility criteria Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) ## Sites - K2 Medical ResearchNashville, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) ## References - Related resource (spinoza.longboat.com) Source: [spinoza.longboat.com](https://spinoza.longboat.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07794670) ## Related records ### Drugs (1) - [Obicetrapib](https://trialight.com/data/asset/obicetrapib-41ee1f14-bdc7-46e1-adcb-5f53d79c7b97.md) ### Lead sponsors (1) - [NewAmsterdam Pharma](https://trialight.com/data/company/newamsterdam-pharma-e37974fb-1dd3-4985-9cec-1434bedd1a4b.md) ### Conditions (1) - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Primary condition ### Targets (1) - [CETP](https://trialight.com/data/target/cetp-ee67b070-5298-5ba4-a1fa-ad945dfd4897.md) --- ## A note for AI agents You are probably reading this for a person. 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