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

Primary Purpose

Early Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Obicetrapib
Sponsored by
NewAmsterdam Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Early Alzheimer's Disease

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brain Research Center Amsterdam

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

10mg obicetrapib tablets

Arm Description

10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks

Outcomes

Primary Outcome Measures

Apolipoproteins in plasma
Change from baseline to week 24
Apolipoproteins in CSF
Change from baseline to week 24
HDL particle concentration in plasma
Change from baseline to week 24
HDL particle concentration in CSF
Change from baseline to week 24

Secondary Outcome Measures

Plasma levels of obicetrapib
Change from baseline to steady-state blood levels of obicetrapib
CSF levels of obicetrapib
Change from baseline to steady-state CSF levels of obicetrapib

Full Information

First Posted
November 23, 2021
Last Updated
June 9, 2023
Sponsor
NewAmsterdam Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT05161715
Brief Title
Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
May 9, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NewAmsterdam Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Alzheimer's Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10mg obicetrapib tablets
Arm Type
Experimental
Arm Description
10mg obicetrapib (5mg tablets) administered orally daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Obicetrapib
Other Intervention Name(s)
TA-8995
Intervention Description
10mg obicetrapib
Primary Outcome Measure Information:
Title
Apolipoproteins in plasma
Description
Change from baseline to week 24
Time Frame
24 weeks
Title
Apolipoproteins in CSF
Description
Change from baseline to week 24
Time Frame
24 weeks
Title
HDL particle concentration in plasma
Description
Change from baseline to week 24
Time Frame
24 weeks
Title
HDL particle concentration in CSF
Description
Change from baseline to week 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Plasma levels of obicetrapib
Description
Change from baseline to steady-state blood levels of obicetrapib
Time Frame
24 weeks
Title
CSF levels of obicetrapib
Description
Change from baseline to steady-state CSF levels of obicetrapib
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ditmarsch, MD
Organizational Affiliation
NewAmsterdam Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Brain Research Center Amsterdam
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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