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

NewAmsterdam Pharma

Status and phase: Enrolling; Phase 2

Conditions: Preclinical Alzheimer's Disease

Treatments: Drug: Obicetrapib 10 mg; Drug: Matching placebo tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07794670

TA 8995 AD 2

Details and patient eligibility

About

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

Enrollment: 400 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• participants with preclinical AD

Exclusion criteria

• APOE genotype not meeting protocol-defined eligibility criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Matching placebo tablets

Obicetrapib

Experimental group

Description:

10 mg Obicetrapib, once daily

Treatment:

Drug: Obicetrapib 10 mg