No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for older adults with conditions like Alzheimer's disease or mild cognitive impairment. Participants will take the study drug NPC-1 and provide information about their health and daily functioning.
Are You a Good Fit for This Trial?
Must not be takingAducanumabLecanemab
Rules you outMajor depressionBipolar disorderSchizophrenia
You may be able to join if
I am 55 years or older.
I have subjective cognitive impairment, mild cognitive impairment, or Alzheimer's disease.
I have a Clinical Dementia Rating of 2 or less.
I have a Mini Mental Status Exam score of 16 or higher.
I have a Geriatric Depression Scale score of less than 6.
I have not changed my Alzheimer’s medications in the past 3 months.
I have specific blood test results showing evidence of Alzheimer's disease.
I have someone available to support me during the trial.
You may not be able to join if
I have a Clinical Dementia Rating greater than 2 or a Mini Mental Status Exam score below 16.
I have had a serious brain condition in the last 2 years.
I have had substance abuse issues in the last 2 years.
I have severe depression or anxiety in the last year.
I have certain uncontrolled health issues, like high blood pressure or heart problems.
I have diabetes that needs insulin.
I have had cancer in the last 5 years, except for certain skin cancers.
I am currently pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 55 and older, male and female;
2. Subjective Cognitive Impairment or MCI or AD dementia per the Revised criteria for diagnosis and staging of Alzheimer's disease criteria;
3. Clinical Dementia Rating \< or = to 2 and Mini Mental Status Exam \> or = to 16;
4. Modified Hach…
Inclusion Criteria:
1. Age 55 and older, male and female;
2. Subjective Cognitive Impairment or MCI or AD dementia per the Revised criteria for diagnosis and staging of Alzheimer's disease 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 1-month prior to screening visit;
7. Biomarker evidence of AD pathology: Plasma abeta42/40 ratio \< or = to 0.12 AND Plasma p-tau217 \> or = to 2.1 pg/mL 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. 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;
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) or INR \> 1.2 (1.3 or higher) or platelets \< 100 K/uL at screening
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:
* a. AD disease modifying monoclonal antibody treatment e.g., donanemab (Kisunla) or lecanemab (Leqembi). Wash out period of five half-lives prior to screening visit is permitted e.g., \> or = 60 days since last dose of donanemab and \> or = 35 days since last dose of lecanemab)
* 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 prior to screening visit
* 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; the presence and dose of these product are recorded
* f. Anticoagulation therapy: Vitamin K antagonist: warfarin (Coumadin, jantoven)
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
15. Currently pregnant. Positive pregnancy tests during the course of the trial will be evaluated at the discretion of the investigator.
Women of Child Bearing Potential (WOCBP)
For the purposes of this study, women of childbearing potential are defined as all women who are capable of becoming pregnant, unless they meet one of the following criteria:
1. 12-months post-menopausal
2. 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 (2 months), Visit 6 (5 months), and Visit 10 (8 months).
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