Biomarker-based Trial of NPC-1 for Alzheimer's Pathology
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55+
SponsorMassachusetts General Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- natural product combination-1 (NPC1)
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov