Seeking optimal repeated fluid biomarker assessments to enhance precision and statistical power in clinical trials: SLIM method.
Hiroko H Dodge, Liu Chen, Chao-Yi Wu...
https://pubmed.ncbi.nlm.nih.gov/41122812Actively Recruiting
Phase 2
Age: 55Years +
All Genders
ID07236190
Early-phase Biomarker-based Trial of NPC-1 for Alzheimer's Disease Pathology
Led by Massachusetts General Hospital · Updated on 2026-06-08
40
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effects of a natural product combination called NPC1, which includes parthenolide and ipriflavone, on blood biomarkers related to Alzheimer's disease in adults. The trial focuses on people aged 55 and older who have subjective cognitive decline, mild cognitive impairment, or Alzheimer's disease with evidence of disease-related changes in their blood. This early phase, open-label, single-arm study aims to understand how NPC1 impacts key indicators of Alzheimer's pathology. During the trial, participants will undergo a lead-in observational period without intervention, followed by an active treatment phase where they receive NPC1. Researchers will collect blood samples before and after treatment to measure several Alzheimer's-related biomarkers such as plasma p-tau217, glial fibrillary acidic protein, neurofilament light chain, and abeta42/abeta40 ratios. The study also monitors safety and tolerability of the NPC1 treatment over six months. Participants will be involved for at least six months, during which they will provide serial blood samples for biomarker analysis and have their health and cognitive status monitored. A study partner who interacts regularly with the participant will help provide information on cognition and daily functioning. The main outcomes include changes in blood biomarkers and assessment of NPC1's safety. The study includes regular clinical assessments and screening for depression and other health conditions to ensure participant well-being throughout the trial.
CONDITIONS
Brief Title
Biomarker-based Trial of NPC-1 for Alzheimer's Pathology
Who Can Participate
Age: 55Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 55 and older, male and female
- Diagnosis of subjective cognitive impairment, mild cognitive impairment, or Alzheimer's dementia according to NIA-AA 2011 criteria
- Clinical Dementia Rating (CDR) score 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 symptoms
- Stable use (3 months or more) of non-disease modifying medications for MCI and AD, such as acetylcholine esterase inhibitors or N-methyl D-aspartate receptor antagonists
- Biomarker evidence of Alzheimer's pathology: plasma abeta42/40 ratio less than or equal to 0.12 and plasma p-tau217 0.25 or higher, or positive Amyloid PET scan (centiloid 20 or higher)
- Sufficient vision and hearing to complete all 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 without interference
You will not qualify if you...
- Clinical Dementia Rating (CDR) greater than 2 or Mini Mental Status Exam (MMSE) less than 16
- Significant central nervous system diseases within the last 2 years, such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis, or cortical stroke
- Alcohol or substance abuse within the last 2 years as defined by DSM-IV criteria
- Major depressive disorder, anxiety within the last year, schizophrenia, bipolar disorder, or other major psychiatric disorders per DSM-IV
- Abnormal laboratory results indicating reversible causes of dementia like vitamin B12 deficiency, thyroid disease, or urinary tract infection (bacterial colonization allowed)
- Unstable or symptomatic cardiovascular disease such as frequent angina or congestive heart failure with breathing difficulty at rest
- Uncontrolled hypertension with blood pressure over 160/100
- Symptomatic orthostatic hypotension
- Diabetes that requires 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 clinical visit per month
- Use of Alzheimer's disease modifying monoclonal antibody treatments
- Use of dietary supplements containing parthenolide or ipriflavone without a 1-month washout
- Use of certain CNS active medications not stable for at least 2 months
- Use of neuroleptics, antiparkinsonian agents, systemic corticosteroids, or narcotic analgesics without adequate washout
- Participation in other Alzheimer's disease interventional trials
- Current pregnancy or positive pregnancy test during the study if applicable
- Women of childbearing potential must meet defined criteria or undergo pregnancy testing during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - Up to baseline before treatment
Participants undergo serial blood-based biomarker collection without receiving the investigational product.
Multiple visits for biomarker collection prior to treatment
Treatment
Duration - 6 months
Participants receive the natural product combination-1 (NPC1) consisting of parthenolide plus ipriflavone and have serial post treatment blood-based biomarkers collected.
Regular visits for treatment and biomarker assessments over 6 months
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02129
Actively Recruiting
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Research Team
G
Gene Bowman, N.D., M.P.H.
B
Brianna Wang
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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