Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease
- Registration Number
- NCT05161715
- Lead Sponsor
- NewAmsterdam Pharma
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- men & women 50-75 years
- post-menopausal or women not of child-bearing potential
- diagnosis of Alzheimer's disease based on National Institute for Aging:
- Biomarker classification A+T+N+ or A+T+N-
- Clinical Stage 3 or 4 with Clinical Dementia Rating score >/= 0.5 & </= 1; mini-mental state examination (MMSE) score >/=20
- Have an APOE genotype of E4/E4 or E3/E4
- not on or on stabilized AD medication
- Patient & study partner willing to sign consent
-
Other than AD, disorder that may impair cognition
-
Contra-indication for MRI
-
History of neurological, psychiatric or mental conditions;
- history stroke
- MI
- Type 1 diabetes & Type 2 with HbA1c>8%
- BP > 150/90 mmHg
- renal or hepatic impaired
- hyperaldosteronism
- cancer
- depression
- laboratory abnormalities
- not able to undergo lumbar puncture
- taking certain medications including lipid altering
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 10mg obicetrapib tablets Obicetrapib 10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks
- Primary Outcome Measures
Name Time Method Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF) 24 weeks Mean percent change from screening (V1) to end of treatment (V6) in ApoA-I in CSF
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Baseline 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)
Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Plasma 24 weeks Mean percent change in ApoA-I in plasma from baseline (V2) to week 24 (V6)
Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF) 24 weeks Mean percent change from screening (V1) to end of treatment (V6) in ApoE
Mean Percent Change in Apolipoprotein-E (ApoE) in Plasma 24 weeks Mean percent change from baseline (V2) to week 24 (V6) in plasma in ApoE
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Week 24 Week 24 Small high-density lipoprotein (s-HDL) particle concentration in CSF measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)
Small HDL (s-HDL) Particle Concentration in Plasma at Baseline 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.12649Small HDL (s-HDL) Particle Concentration in Plasma at Week 24 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.12649Mean Percent Change in Cholesterol Efflux Capacity in Cerebrospinal Fluid (CSF) 24 weeks Mean percent change in cholesterol efflux capacity in CSF from screening (V1) to week 24 (V6)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Brain Research Center Amsterdam
🇳🇱Amsterdam, Netherlands