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

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NewAmsterdam Pharma

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 &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