Actively Recruiting
Biomarker-based Trial of NPC-1 for Alzheimer's Pathology
Led by Massachusetts General Hospital · Updated on 2026-05-08
40
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Biomarker-based Trial of NPC-1 for Alzheimer's Pathology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 and older, male and female
- Subjective cognitive impairment, mild cognitive impairment (MCI), or Alzheimer's disease dementia based on NIA-AA 2011 criteria
- Clinical Dementia Rating (CDR) less than or equal to 2 and Mini Mental Status Exam (MMSE) score 16 or higher
- Modified Hachinski Ischemic Score less than or equal to 4
- Geriatric Depression Scale-15 score less than 6, indicating no significant depressive syndromes
- Stable use of other medications for MCI or AD for at least 3 months (e.g., acetylcholine esterase inhibitor or N-methyl D-aspartate receptor antagonist)
- Biomarker evidence of Alzheimer's disease pathology: plasma abeta42/40 ratio less than or equal to 0.12 and plasma p-tau217 of 0.25 or higher, or positive amyloid PET scan
- Sufficient vision and hearing to complete study tests
- Availability of a study partner with frequent contact (at least 1 hour per day or 1 day per week) to provide information and support
- General health status that allows completion of the study
You will not qualify if you...
- Clinical Dementia Rating greater than 2 or Mini Mental Status Exam score less than 16
- Significant central nervous system disease within the last 2 years (e.g., brain tumor, seizure disorder, subdural hematoma, cranial arteritis, cortical stroke)
- Alcohol or substance abuse within the last 2 years
- Major depressive disorder, anxiety within the last year, schizophrenia, bipolar disorder, or other major psychiatric disorder
- Abnormal laboratory tests indicating reversible causes of dementia such as vitamin B12 deficiency, thyroid disease, or urinary tract infection
- Unstable or symptomatic cardiovascular disease (e.g., frequent angina, congestive heart failure with resting dyspnea)
- Uncontrolled hypertension with blood pressure greater than 160/100
- Clinical symptomatic orthostatic hypotension
- Diabetes mellitus requiring insulin injections
- Hachinski ischemic score 4 or higher
- Cancer within the last 5 years except localized low-grade prostate cancer and non-metastatic skin cancers
- Illness requiring more than one clinician visit per month
- Use of certain medications including Alzheimer's disease modifying monoclonal antibodies, dietary supplements containing parthenolide or ipriflavone (unless washed out for 1 month), unstable CNS-active medications, neuroleptics, antiparkinsonian agents, systemic corticosteroids, and narcotic analgesics
- Participation in any Alzheimer's disease interventional trial
- Currently pregnant; women of childbearing potential must follow pregnancy testing and contraception guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02129
Actively Recruiting
Research Team
G
Gene Bowman, N.D., M.P.H.
CONTACT
B
Brianna Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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