Trials / Completed
CompletedNCT05161715
Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease
A Phase 2a, Proof-of-Concept, Open-Label Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Obicetrapib in Patients With Early Alzheimer's Disease (Hetero/Homozygote APOE4 Carriers)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- NewAmsterdam Pharma · Industry
- Sex
- All
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 2a study in men and women with early Alzheimer's disease to evaluate the pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy.
Detailed description
This study will be a proof of concept, Phase 2a study in patients with early Alzheimer's disease (clinical diagnosis of Alzheimer's disease Stage 3 or 4 based on the National Institute on Aging Alzheimer's Association Research Framework criteria) to evaluate the Pharmacodynamic, cognitive effects, Pharmacokinetic, and safety and tolerability of obicetrapib therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Obicetrapib | 10mg obicetrapib |
Timeline
- Start date
- 2022-01-12
- Primary completion
- 2023-05-09
- Completion
- 2023-06-01
- First posted
- 2021-12-17
- Last updated
- 2025-01-29
- Results posted
- 2024-11-19
Locations
1 site across 1 country: Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05161715. Inclusion in this directory is not an endorsement.