A Phase 2a study in men and women with early Alzheimer's disease to evaluate the pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
13
10mg obicetrapib
Brain Research Center Amsterdam
Amsterdam, Netherlands
Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF)
Mean percent change from screening (V1) to end of treatment (V6) in ApoA-I in CSF
Time frame: 24 weeks
Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Plasma
Mean percent change in ApoA-I in plasma from baseline (V2) to week 24 (V6)
Time frame: 24 weeks
Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF)
Mean percent change from screening (V1) to end of treatment (V6) in ApoE
Time frame: 24 weeks
Mean Percent Change in Apolipoprotein-E (ApoE) in Plasma
Mean percent change from baseline (V2) to week 24 (V6) in plasma in ApoE
Time frame: 24 weeks
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Baseline
Small high-density lipoprotein (s-HDL) particle concentration in cerebrospinal fluid (CSF) measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
Time frame: baseline
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Week 24
Small high-density lipoprotein (s-HDL) particle concentration in CSF measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
Time frame: Week 24
Small HDL (s-HDL) Particle Concentration in Plasma at Baseline
Small high-density lipoprotein (s-HDL) particle concentration plasma measured by Ion Mobility Assay. For more information on the measurement used please refer to this article: https://doi.org/10.1002/alz.12649
Time frame: baseline
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Small HDL (s-HDL) Particle Concentration in Plasma at Week 24
Small high-density lipoprotein (s-HDL) particle concentration in plasma measured by Ion Mobility Assay at Week 24 For more information on the measurement used please refer to this article: https://doi.org/10.1002/alz.12649
Time frame: Week 24
Mean Percent Change in Cholesterol Efflux Capacity in Cerebrospinal Fluid (CSF)
Mean percent change in cholesterol efflux capacity in CSF from screening (V1) to week 24 (V6)
Time frame: 24 weeks