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

Phase 2

Completed

• Conditions: Early Alzheimer's Disease
• Interventions: Drug: Obicetrapib

• 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.

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-12-03
• Study First Posted: 2021-12-17
• Study Start: 2022-01-12
• Primary Completion: 2023-05-09
• Study Completion: 2023-06-01
• Status Verified: 2024-10
• Results First Submitted: 2024-10-25
• Results First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Results First Posted: 2024-11-19
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

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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

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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)	Between 24 to 32 weeks	Mean percent change from screening (V1) to end of treatment (V6) in ApoA-I in CSF
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)	Between 24 to 32 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 Baseline	baseline	Small high-density lipoprotein (s-HDL) particle concentration in cerebrospinal fluid (CSF)
Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Week 24	Between 24 and 32 weeks	Small high-density lipoprotein (s-HDL) particle concentration in CSF at Week 24
Mean 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)

Trial Locations

Locations (1)

Brain Research Center Amsterdam; 🇳🇱 Amsterdam, Netherlands