NCT05161715 · Phase 2 · COMPLETED
Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease
This trial is testing obicetrapib — a cholesterol-modifying drug — in people with early Alzheimer's disease. Researchers want to see how the drug moves through the body, what it does to biological markers, and whether it is safe. It is a Phase 2a study, meaning it is an early proof-of-concept test in a small group of patients, not a large-scale effectiveness trial. Details beyond that are limited in the public summary.
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-01-29