Early-phase Biomarker-based Trial of NPC-1 for Alzheimer's Disease Pathology
This early phase, open label, single arm clinical trial will determine the intraindividual safety, tolerability and effects of NPC1 (parthenolide and ipriflavone) on blood-based biomarkers of Alzheimer's disease (AD) pathology among adults with subjective cognitive decline, mild cognitive impairment, or Alzheimer's disease and objective indicators of seeding AD pathology
• Age 55 and older, male and female;
• Subjective Cognitive Impairment or MCI or AD dementia per NIA-AA 2011 criteria;
• Clinical Dementia Rating \< or = to 2 and Mini Mental Status Exam \> or = to 16;
• Modified Hachinski Ischemic Score \< or = to 4
• Geriatric Depression Scale - 15 \< 6 documenting absence from significant depressive syndromes
• Other medications including non-disease modifying for MCI and AD (e.g., acetylcholine esterase inhibitor, N-methyl D-aspartate receptor antagonist) stable \> or = to 3-months ;
• Biomarker evidence of AD pathology: Plasma abeta42/40 ratio \< or = to 0.12 AND Plasma p-tau217 \> or = to 0.25 OR Amyloid PET positive (centiloid \> or = to 20) as part of routine clinical care.
• Sufficient vision and hearing to complete all tests
• Study partner available with frequent (at least 1 hour/day or 1 day/week) contact with participant to provide collateral information about cognition, daily functioning, adverse events reporting, and support for study drug intake
⁃ General health status that will not interfere with the ability to complete the prospective study (these conditions are listed below in the study exclusion list)