Early-phase Biomarker-based Trial of NPC-1 for Alzheimer's Disease Pathology
Massachusetts General Hospital
Summary
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
Eligibility
- Age range
- 55+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 55 and older, male and female; 2. Subjective Cognitive Impairment or MCI or AD dementia per NIA-AA 2011 criteria; 3. Clinical Dementia Rating \< or = to 2 and Mini Mental Status Exam \> or = to 16; 4. Modified Hachinski Ischemic Score \< or = to 4 5. Geriatric Depression Scale - 15 \< 6 documenting absence from significant depressive syndromes 6. 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 ; 7. Biomarker evidence of AD pathology: Plasma…
Interventions
- Combination Productnatural product combination-1 (NPC1)
parthenolide plus ipriflavone
Location
- Massachusetts General HospitalBoston, Massachusetts