Randomized Study to Evaluate the Effect of Obicetrapib in Participants With Preclinical Alzheimer's Disease

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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07794670

Acronym

SPINOZA

Enrollment

400

Registered

2026-08-31

Start date

2026-09-01

Completion date

2029-05-01

Last updated

2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preclinical Alzheimer's Disease

Keywords

Preclinical, Alzheimer's Disease, ptau 217, ApoE

Brief summary

A study evaluating Obicetrapib in adults potentially at risk for Preclinical Alzheimer's Disease

Interventions

DRUGObicetrapib 10 mg

once daily 10 mg Obicetrapib tablet

DRUGMatching placebo tablets

matching placebo tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

Healthy volunteers

Inclusion criteria

* participants with preclinical AD

Exclusion criteria

* APOE genotype not meeting protocol-defined eligibility criteria

Design outcomes

Primary

Measure	Time frame
Change from Baseline to Week 52 in ptau 217	Baseline, Week 52

Secondary

Measure	Time frame	Description
Change from Baseline to Week 52 in Alzheimer's disease related biomarker Amyloid β 42/Amyloid β 40 ratio	Baseline, Week 52	Measure changes in proteins that can be early signs of Alzheimer's disease.
Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42 ratio	Baseline, Week 52	Measure changes in two proteins that can be early signs of Alzheimer's disease.
Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42/Amyloid β40 ratio	Baseline, Week 52	Measure changes in three proteins that can be early signs of Alzheimer's disease.
Change from Baseline to Week 52 in Alzheimer's disease related biomarker BD-tau	Baseline, Week 52	Measures a protein released from brain cells that can be early signs of Alzheimer's disease.
Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026