Phase 2 N=13 Prevention

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

Early Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT05161715 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF) — -8.4 percent change from screening visit — p=0.425

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Obicetrapib (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: NewAmsterdam Pharma
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Cerebrospinal Fluid (CSF)	-8.4	0.425
PRIMARY Mean Percent Change in Apolipoprotein A-I (ApoA-I) in Plasma	37.5	0.0002 sig
PRIMARY Mean Percent Change in Apolipoprotein-E (ApoE) in Cerebrospinal Fluid (CSF)	3.9	0.0424 sig
PRIMARY Mean Percent Change in Apolipoprotein-E (ApoE) in Plasma	47.8	0.001 sig
PRIMARY Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Baseline	0.542	—
PRIMARY Small HDL (s-HDL) Particle Concentration in Cerebrospinal Fluid (CSF) at Week 24	0.542	—
PRIMARY Small HDL (s-HDL) Particle Concentration in Plasma at Baseline	—	—
PRIMARY Small HDL (s-HDL) Particle Concentration in Plasma at Week 24	—	—
PRIMARY Mean Percent Change in Cholesterol Efflux Capacity in Cerebrospinal Fluid (CSF)	1.9	0.556

Summary

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

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 & /=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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05161715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.