Safety, Tolerability and Biomarker-based Efficacy of NPI-001 (AT-001) in Subjects With MCI or Alz… (NCT07741526) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Safety, Tolerability and Biomarker-based Efficacy of NPI-001 (AT-001) in Subjects With MCI or Alzheimer's Disease (AD)
Denmark, Iceland33 participantsStarted 2025-10-14
Plain-language summary
The study aims to measure safety, tolerability and biomarker-based efficacy of NPI-001 (AT-001) in Subjects with MCI or Alzheimer's Disease (AD).
In the study participants receive increasing dose of active treatment (250mg vs 500mg vs 750mg) or matched placebo in the form of tablets BID.
Who can participate
Age range
50 Years – 84 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject has provided informed consent for participation in trial.
. Subject is male or female, aged 50 or older but younger than 85.
. Female Subjects:
. Male subjects:
. Subject has MCI or mild dementia due to Alzheimer´s disease according to Jack 2024 with a CDR of 0.5 or 1.0 receiving standard AD care (SOC) (65).
. Subject has an MMSE score of \>21 \< 28
. Subject is willing to have a baseline and follow up blood tests according to the schedule of assessments, for up to 12 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial focused mainly on safety, so what does that mean for how much we'd actually know about whether NPI-001 works for Alzheimer's or MCI before I consider joining?
2The trial is actively monitoring for ARIA — which are brain swelling and microbleeds seen on MRI — so what would my personal risk of developing ARIA look like based on my current health and imaging history?
3Since this trial is listed as 'active not recruiting,' does that mean enrollment is already closed, and if so, are there similar or more advanced trials that might be worth exploring instead?
4One of the key things being measured is safety labs staying within normal range — are there any existing conditions I have, like kidney or liver issues, that might make monitoring these labs more complicated or risky for me?
5Given that the primary goal here is testing tolerability rather than proving effectiveness, would it make sense to try an established standard-of-care treatment first, and how would that affect my eligibility for this or future trials?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment -Emergent Adverse Events
Timeframe: Through study completion, approximately up to 14 months
2
Safety labs results within normal range
Timeframe: Through study completion, approximately up to 14 months
3
Assessment of ARIA H and ARIA E in the brain with MRI imaging
Timeframe: Through study completion, approximately up to 14 months
0. Subject is able to read, write, speak clearly for the cognitive tests, with eyesight and hearing sufficient to enable completion of the cognitive tests.
. Subject has MRI evidence evaluated by central read of
. Brain abnormality caused by other neurological disease than AD including but not limited to vascular disease (vascular dementia), acute or subacute cerebral hemorrhage, large-vessel stroke, brain tumors, inflammatory immunological or metabolic disorders.
. More than 7 microbleeds, multiple lacunes or any lacune in strategically important location, Grade 2 and 3 white matter lesions, any focal area of superficial siderosis or medical implants or foreign bodies unsuitable for MRI.
. Subject has moderate or severe dementia, defined as CDR of ≥ 2.0
. Subject has clinically significant illness, mental or physical, that, in the opinion of the investigator, might confound the results of the study, pose additional risk to the Subject by their participation, or prevent/impede the subject from completing the study.
. Subject has known sensitivity to NAC/NACA.
. Known or recently suspected (3 months) excessive alcohol or drug abuse.