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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-06-30

Brief Summary

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The goal of this early phase, open-label, single arm clinical trial is to determine the 6-month effects and tolerability of NPC1 (parthenolide and ipriflavone) on biomarkers of Alzheimer's Disease among adults with objective indicators of seeding AD pathology that also have subjective cognitive concerns, Mild Cognitive Impairment, or Alzheimer's Disease (AD)

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Detailed Description

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Conditions

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Alzheimer Disease Mild Cognitive Impairment (MCI) Subjective Cognitive Complaints (SCCs)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Single arm, lead in to intervention with blood biomarkers collected before and after treatment with two over the counter natural products combined as natural product combination-1 (NPC1)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Analytical chemists running the biomarker analyses are blind to whether participants were on active treatment of in the lead in phase of the trial

Study Groups

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Open label intervention with NPC1

Three capsules of NPC1 taken daily. One 300 mg cap of Ipriflavone and 1 cap of 2.5 mg Parthenolide in the morning; One 300 mg cap of Ipriflavone taken in the evening)

Group Type ACTIVE_COMPARATOR

NPC1

Intervention Type DRUG

NPC1 (parthenolide and ipriflavone)

Lead-in observational period

Serial blood draws to characterize pre-treatment biomarker status

Group Type PLACEBO_COMPARATOR

NPC1-Placebo/Control

Intervention Type DRUG

Participants with undergo serial blood draws off active drug

Interventions

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NPC1

NPC1 (parthenolide and ipriflavone)

Intervention Type DRUG

NPC1-Placebo/Control

Participants with undergo serial blood draws off active drug

Intervention Type DRUG

Other Intervention Names

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Observational period

Eligibility Criteria

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Inclusion Criteria

1. Age 55 and older, male and female;
2. Subjective Cognitive Impairment or MCI or AD dementia per NIA-AA 2011 criteria;
3. Clinical Dementia Rating \< or = to 2 and Mini Mental Status Exam \> or = to 16;
4. Modified Hachinski Ischemic Score \< or = to 4
5. Geriatric Depression Scale - 15 \< 6 documenting absence from significant depressive syndromes
6. 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 ;
7. 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.
8. Sufficient vision and hearing to complete all tests
9. 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 drug intake
10. 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)

Exclusion Criteria

1. CDR \> 2 MMSE \< 16;
2. Significant CNS disease within the last 2 years (i.e., brain tumor, seizure disorder, subdural hematoma, cranial arteritis, cortical stroke);
3. Alcohol or substance abuse according to DSM-IV criteria within the last 2 years
4. Major depressive disorder or anxiety within the last year; Schizophrenia, bipolar disorder or other major psychiatric disorder defined by DSM-IV criteria
5. Abnormal labs indicating potential reversible causes of dementing illness such as vitamin B12 deficiency, thyroid disease, or UTI (documented bacterial colonization is acceptable)
6. Unstable or significantly symptomatic CVD (e.g. CAD with frequent angina, CHF with dyspnea at rest)
7. Hypertension: defined as uncontrolled BP \> 160/100
8. Clinical symptomatic orthostatic hypotension
9. Diabetes mellitus that requires insulin injections
10. Hachinski ischemic score \> or = to 4
11. Cancer within the last 5 years, apart from localized prostate cancer (Gleason Grade \< 3) and non-metastatic skin cancers (melanoma).
12. Illness that requires \>1 visit /month to a clinician
13. Medications and dietary supplements:

1. AD disease modifying monoclonal antibody treatment e.g., aducanumab or lecanemab
2. Dietary supplements containing parthenolide or ipriflavone (1-month wash out period prior to enrollment is permitted)
3. CNS active meds that have not been on stable doses for at least 2 months e.g., cimetidine, beta-blockers, and SSRIs
4. Neuroleptics, antiparkinsonian agents, systemic corticosteroids, and narcotic analgesics; in the case where these were used for a self-limited time they must have been discounted for a period of five half-lives prior to baseline visit
5. 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; the presence and dose of these product are recorded
14. Participation in any Alzheimer's Disease interventional trial. Participation in other non-AD related trials will be evaluated at the discretion of the investigator

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No