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
This trial does not accept healthy volunteersQualifiers
Age 55 and older, male and female;
Subjective Cognitive Impairment or MCI or AD dementia per the Revised criteria for diagnosis and staging of Alzheimer's disease 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;
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;
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
Design model
Single group
Treatments tested in this trial
natural product combination-1 (NPC1)
Combination productparthenolide plus ipriflavone
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Lead-in observational periodNo intervention 0 interventions
Group B: Active interventional periodActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
plasma p-tau217
Intra-individual changes from pre-treatment observational period to post-treatment interventional period
Time frame
6 months2
plasma glial fibrillary acidic protein
Intraindividual changes
Time frame
6 months3
plasma neurofilament light chain
Intra-individual changes
Time frame
6 months4
plasma abeta42 / abeta40
Intraindividual changes
Time frame
6 monthsSecondary outcomes
1
plasma hsTNFalpha
intra-individual changes
Time frame
6 monthsOther outcomes
1
Safety and Tolerability
Analysis of Complete Blood Count (CBC) with differential values from baseline through the end of the 6 month treatment period will be measured to assess for safety and tolerability of NPC1 intervention.
Time frame
Baseline through 6 months2
Safety and Tolerability
Analysis of Comprehensive Metabolic Panel (CMP) values from baseline through the end of the 6 month treatment period will be measured to assess for safety and tolerability of NPC1 intervention.
Time frame
Baseline through 6 months3
Safety and Tolerability
Analysis of Prothrombin time/International Normalized Ratio (PT/INR) values from baseline through the end of the 6 month treatment period will be measured to assess for safety and tolerability of NPC1 intervention.
Time frame
Baseline through 6 months4
Clinical Dementia Rating sum of boxes
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov