Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease

Sponsor
NewAmsterdam Pharma
Study ID
NCT05161715
Phase
PHASE2
Status
Completed

Conditions

  • Early Alzheimer's Disease

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

A Phase 2a study in men and women with early Alzheimer's disease to evaluate the pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy.

Key Dates

Start date
Jan 12, 2022
Status verified
Oct 2024
Primary completion
May 9, 2023
Completion
Jun 1, 2023

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: 10mg obicetrapib tablets
    10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks

Primary Outcome Measure

Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF) [ Time Frame: 24 weeks ]

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