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

NCT07794670
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
400
clinicaltrials.gov
Lead sponsor
NewAmsterdam Pharma
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Start date
2026-09-01
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Number of sites
1
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Summary
A study evaluating Obicetrapib in adults potentially at risk for Preclinical Alzheimer's Disease
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Acronym
SPINOZA
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Short title
Randomized Study to Evaluate the Effect of Obicetrapib in Participants With Preclinical Alzheimer's Disease
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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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2029-05-01
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First posted
2026-08-31
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Registry last updated
2026-09-28
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Primary completion date
2028-09-01
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Start date
2026-09-01
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Participants
400
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Participant count basis
Estimated
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Planned participants
400
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
NewAmsterdam Pharma
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07794670
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ClinicalTrials.gov ID
NCT07794670
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  1. Change from Baseline to Week 52 in ptau 217

    Timeframe: Baseline, Week 52

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
55 Years
Maximum age
85 Years
Healthy volunteers
No

  • participants with preclinical AD

  • APOE genotype not meeting protocol-defined eligibility criteria
Sources for eligibility
clinicaltrials.gov

  • K2 Medical ResearchNashville, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)