Preclinical Alzheimer's DiseasePhase 2SPINOZANCT07794670
Randomized Study to Evaluate the Effect of Obicetrapib in Participants With Preclinical Alzheimer's Disease
A Phase 2 study testing Obicetrapib 10 mg in people with Preclinical Alzheimer's Disease, run by NewAmsterdam Pharma at 1 site in United States.
Trial summary
A study evaluating Obicetrapib in adults potentially at risk for Preclinical Alzheimer's Disease Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Preclinical Alzheimer's Disease
- What is being tested?
- Obicetrapib 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to May 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants with preclinical AD
Who cannot join
- APOE genotype not meeting protocol-defined eligibility criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
K2 Medical Research
Nashville, Tennessee, 37204
Victoria Marsh, 615-208-K2K2 (5252), victoria.marsh@k2med.com
About this study
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)
A study evaluating Obicetrapib in adults potentially at risk for Preclinical Alzheimer's Disease
- Conditions
- Preclinical Alzheimer's Disease
- Being tested
- Obicetrapib 10 mg, Matching placebo tablets
- Keywords
- Preclinical, Alzheimer's Disease, ptau 217, ApoE
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obicetrapib 10 mgDrug
once daily 10 mg Obicetrapib tablet
Matching placebo tabletsDrug
matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Matching placebo tablets |
| Obicetrapib | Experimental | 10 mg Obicetrapib, once daily Receives: Drug: Obicetrapib 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 52 in ptau 217
Measured: Baseline, Week 52
Secondary outcomes (5)
Change from Baseline to Week 52 in Alzheimer's disease related biomarker Amyloid β 42/Amyloid β 40 ratio
Measure changes in proteins that can be early signs of Alzheimer's disease.
Measured: Baseline, Week 52
Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42 ratio
Measure changes in two proteins that can be early signs of Alzheimer's disease.
Measured: Baseline, Week 52
Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42/Amyloid β40 ratio
Measure changes in three proteins that can be early signs of Alzheimer's disease.
Measured: Baseline, Week 52
Change from Baseline to Week 52 in Alzheimer's disease related biomarker BD-tau
Measures a protein released from brain cells that can be early signs of Alzheimer's disease.
Measured: Baseline, Week 52
Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score
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.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preclinical Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NewAmsterdam Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794670
- Sponsor's protocol ID
- TA 8995 AD 2
- Acronym
- SPINOZA
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No