RecruitingPhase 2

Biomarker-based Trial of NPC-1 for Alzheimer's Pathology

United States40 participantsStarted 2026-04-01

Plain-language 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

Who can participate

Age range55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. CDR \> 2 MMSE \< 16;
✕. Significant CNS disease within the last 2 years (i.e., brain tumor, seizure disorder, subdural hematoma, cranial arteritis, cortical stroke);
✕. Alcohol or substance abuse according to DSM-IV criteria within the last 2 years
✕. Major depressive disorder or anxiety within the last year; Schizophrenia, bipolar disorder or other major psychiatric disorder defined by DSM-IV criteria

What they're measuring

plasma p-tau217

Timeframe: 6 months

plasma glial fibrillary acidic protein

Timeframe: 6 months

plasma neurofilament light chain

Timeframe: 6 months

plasma abeta42 / abeta40

Timeframe: 6 months

Safety and Tolerability of NPC1

Timeframe: Baseline through 6 months

Trial details

NCT IDNCT07236190

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Gene Bowman, N.D., M.P.H.

857-282-5197 glbowman@mgh.harvard.edu

View on ClinicalTrials.gov More Alzheimer Disease trials

Plain-language summary

Who can participate

Age range55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. CDR \> 2 MMSE \< 16;
✕. Significant CNS disease within the last 2 years (i.e., brain tumor, seizure disorder, subdural hematoma, cranial arteritis, cortical stroke);
✕. Alcohol or substance abuse according to DSM-IV criteria within the last 2 years
✕. Major depressive disorder or anxiety within the last year; Schizophrenia, bipolar disorder or other major psychiatric disorder defined by DSM-IV criteria