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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07794670
- Acronym / sponsor ID
- SPINOZA / TA 8995 AD 2
- Conditions
- Preclinical Alzheimer's Disease
- Keywords
- Preclinical, Alzheimer's Disease, ptau 217, ApoE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- NewAmsterdam PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study evaluating Obicetrapib in adults potentially at risk for Preclinical Alzheimer's Disease
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Matching placebo tabletsPlacebo |
| Obicetrapib | Experimental | Drug: Obicetrapib 10 mg10 mg Obicetrapib, once daily |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participants with preclinical AD
Key exclusion criteria (1 listed)
- APOE genotype not meeting protocol-defined eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obicetrapib 10 mgonce daily 10 mg Obicetrapib tablet | Drug | Obicetrapib |
| Matching placebo tabletsmatching placebo tablet | Drug | Placebo |
Primary outcome
Change from Baseline to Week 52 in ptau 217
Time frame: Baseline, Week 52
5 secondary outcomes
Change from Baseline to Week 52 in Alzheimer's disease related biomarker Amyloid β 42/Amyloid β 40 ratio
Time frame: Baseline, Week 52
Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42 ratio
Time frame: Baseline, Week 52
Change from Baseline to Week 52 in Alzheimer's disease related biomarker p-tau217/Amyloid β42/Amyloid β40 ratio
Time frame: Baseline, Week 52
Change from Baseline to Week 52 in Alzheimer's disease related biomarker BD-tau
Time frame: Baseline, Week 52
Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score
Time frame: Baseline, Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Prescreening Participant PortalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 52 in ptau 217 (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.