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NCT Number: NCT07794670

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

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

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Key information

Conditions

Preclinical Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participants with preclinical AD

Exclusion criteria

  • APOE genotype not meeting protocol-defined eligibility criteria

Treatment and study plan

Obicetrapib 10 mg

Drug

once daily 10 mg Obicetrapib tablet

Matching Placebo Tablets

Drug

matching placebo tablet

Primary outcomes

  1. Change from Baseline to Week 52 in ptau 217

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NewAmsterdam Pharma

Industry

Registry information

Official study 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)

Acronym: SPINOZA

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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