RecruitingAlzheimer DiseaseMild Cognitive Impairment (MCI)Subjective Cognitive Decline (SCD)
Biomarker-based Trial of NPC-1 for Alzheimer's Pathology
Eligible age
55+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ 1. Age 55 and older, male and female;
- ✓ 2. Subjective Cognitive Impairment or MCI or AD dementia per the Revised criteria for diagnosis and staging of Alzheimer's disease 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 1-month prior to screening visit;
- ✓ 7. Biomarker evidence of AD pathology: Plasma abeta42/40 ratio \< or = to 0.12 AND Plasma p-tau217 \> or = to 2.1 pg/mL OR Amyloid PET positive (centiloid \> or = to 20) as part of routine clinical care.
- ✓ 8. Sufficient vision and hearing to complete all tests
You may not qualify if…
- ✕ 1. CDR \> 2 MMSE \< 16;
- ✕ 2. Other significant CNS disease within the last 2 years (i.e., brain tumor, seizure disorder, subdural hematoma, cranial arteritis, cortical stroke) That would impact the participant's ability to complete the study;
- ✕ 3. Alcohol or substance abuse according to DSM-IV criteria within the last 2 years
- ✕ 4. Major depressive disorder or anxiety within the last year; Schizophrenia, bipolar disorder or other major psychiatric disorder defined by DSM-IV criteria
- ✕ 5. Abnormal labs indicating potential reversible causes of dementing illness such as vitamin B12 deficiency, thyroid disease, or UTI (documented bacterial colonization is acceptable) or INR \> 1.2 (1.3 or higher) or platelets \< 100 K/uL at screening
- ✕ 6. Unstable or significantly symptomatic CVD (e.g. CAD with frequent angina, CHF with dyspnea at rest)
- ✕ 7. Hypertension: defined as uncontrolled BP \> 160/100
- ✕ 8. Clinical symptomatic orthostatic hypotension
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT07236190 · last updated 2026-10-13