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NCT Number: NCT05161715

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

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

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Key information

Conditions

Early Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brain Research Center Amsterdam

Amsterdam, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Obicetrapib

Drug

10mg obicetrapib

Other names: TA-8995

Primary outcomes

  1. Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF)

    Time frame: 24 weeks

    Mean percent change from screening (V1) to end of treatment (V6) in ApoA-I in CSF

  2. Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Plasma

    Time frame: 24 weeks

    Mean percent change in ApoA-I in plasma from baseline (V2) to week 24 (V6)

  3. Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF)

    Time frame: 24 weeks

    Mean percent change from screening (V1) to end of treatment (V6) in ApoE

  4. Mean Percent Change in Apolipoprotein-E (ApoE) in Plasma

    Time frame: 24 weeks

    Mean percent change from baseline (V2) to week 24 (V6) in plasma in ApoE

  5. Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Baseline

    Time frame: 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)

  6. Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Week 24

    Time frame: Week 24

    Small high-density lipoprotein (s-HDL) particle concentration in CSF measured by Ion Mobility Assay (https://doi.org/10.1002/alz.12649)

  7. Small HDL (s-HDL) Particle Concentration in Plasma at Baseline

    Time frame: 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

  8. Small HDL (s-HDL) Particle Concentration in Plasma at Week 24

    Time frame: 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

  9. Mean Percent Change in Cholesterol Efflux Capacity in Cerebrospinal Fluid (CSF)

    Time frame: 24 weeks

    Mean percent change in cholesterol efflux capacity in CSF from screening (V1) to week 24 (V6)

Sponsors and collaborators

Lead sponsor

NewAmsterdam Pharma

Industry

Registry information

Official study title

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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2021
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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