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

Early Alzheimer's Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05161715
• Other study ID #: TA-8995 AD-1
• Status: Completed
• Phase: Phase 2
• Start date: January 12, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: NewAmsterdam Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 1, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Early Alzheimer's Disease

Intervention

Drug:
• Obicetrapib
10mg obicetrapib

Locations

Country	Name	City	State
Netherlands	Brain Research Center Amsterdam	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
NewAmsterdam Pharma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apolipoproteins in plasma	Change from baseline to week 24	24 weeks
Primary	Apolipoproteins in CSF	Change from baseline to week 24	24 weeks
Primary	HDL particle concentration in plasma	Change from baseline to week 24	24 weeks
Primary	HDL particle concentration in CSF	Change from baseline to week 24	24 weeks
Primary	Cholesterol efflux in CSF	Change from baseline to week 24	24 weeks