Clinical trial for Alzheimer Disease
Official title Biomarker-based Trial of NPC-1 for Alzheimer's Pathology
ClinicalTrials.gov ID: NCT07236190
What this study is testing
What is natural product combination-1 (NPC1)?
an investigational oral combination product being studied as a potential treatment for Alzheimer disease
Also referred to as parthenolide, ipriflavone.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether NPC1 (parthenolide and ipriflavone) changes blood markers of Alzheimer disease.
- Who it's for
- You may be able to join if you have mild cognitive decline, mild cognitive impairment, or early Alzheimer signs.
- What's involved
- You will take NPC1 pills and have blood tests to check the markers. You will visit the clinic a few times.
- Time commitment
- The study lasts a few months and includes several clinic visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- 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 16;
- Modified Hachinski Ischemic Score \< or = to 4
- Geriatric Depression Scale - 15 \< 6 documenting absence from significant depressive syndromes
You likely can't join if
- 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)...
- 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...
- Abnormal labs indicating potential reversible causes of dementing illness such as vitamin B12 deficiency, thyroid disease, or UTI (documented...
- Unstable or significantly symptomatic CVD (e.g. CAD with frequent angina, CHF with dyspnea at rest)
See the full eligibility criteria
- 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 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 1-month prior to screening visit;
- Biomarker evidence of AD pathology: Plasma abeta42/40 ratio \ or = to 2.1 pg/mL OR Amyloid PET positive (centiloid \> or = to 20) as part of routine clinical care.
- Sufficient vision and hearing to complete all tests
- Study partner available with frequent (at least 1 hour/day or 1 day/week) contact with participant to provide collateral information about cognition, daily functioning, adverse events reporting, and support for study...
- General health status that will not interfere with the ability to complete the prospective study (these conditions are listed below in the study exclusion list)
- 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
- Abnormal labs indicating potential reversible causes of dementing illness such as vitamin B12 deficiency, thyroid disease, or UTI (documented bacterial colonization is acceptable) or INR \> 1.2 (1.3 or higher) or...
- Unstable or significantly symptomatic CVD (e.g. CAD with frequent angina, CHF with dyspnea at rest)
- Hypertension: defined as uncontrolled BP \> 160/100
- Clinical symptomatic orthostatic hypotension
- Diabetes mellitus that requires insulin injections
- Hachinski ischemic score \> or = to 4
- Cancer within the last 5 years, apart from localized prostate cancer (Gleason Grade \< 3) and non-metastatic skin cancers (melanoma).
- Illness that requires \>1 visit /month to a clinician
- a. AD disease modifying monoclonal antibody treatment e.g., donanemab (Kisunla) or lecanemab (Leqembi).
- b. Dietary supplements containing parthenolide or ipriflavone (1-month wash out period prior to screening is permitted)
- c. CNS active meds that have not been on stable doses for at least 1 month prior to screening visit e.g., cimetidine, beta-blockers, and SSRIs
- d. Neuroleptics, antiparkinsonian agents, systemic corticosteroids, and narcotic analgesics; in the case where these were used for a self-limited time they must have been discontinued for a period of five half-lives...
- e. Over the counter supplements are not by themselves exclusionary, however, participants are asked not to change the dosing regimen over the course of the trial unless medically indicated
- f. Anticoagulation therapy: Vitamin K antagonist: warfarin (Coumadin, jantoven)
- Participation in any Alzheimer's Disease treatment trial. Participation in other non-AD related trials will be evaluated at the discretion of the investigator
- 12-months post-menopausal
- Post-hysterectomy/surgically sterile If a female Participant does not meet either of these criteria they will be considered of childbearing potential and will have a serum pregnancy test performed at Screening, Visit 3...
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.