Can a pill clear the toxic proteins behind Alzheimer's?
NCT ID NCT07741526
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This trial tests an experimental drug called NPI-001 in people aged 50 to 85 with mild cognitive impairment or mild Alzheimer's disease. Participants take either the drug or a placebo as tablets twice daily for 12 months, with doses increasing over time. The study measures safety and whether the drug reduces harmful amyloid proteins and other Alzheimer's-related biomarkers in the blood. It aims to see if NPI-001 can slow the disease process at an early stage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NPI-001 (AT-001) tablets taken by mouth twice daily
- What this could lead to
- If successful, this could point toward a treatment that slows or halts Alzheimer's-related brain damage by targeting toxic protein clumps.
- What could go wrong
- This is an early, small trial focused on safety and biomarkers, not proof of clinical benefit. The drug may not show meaningful effects or could cause side effects like brain swelling (ARIA).
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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33 people
The number who actually took part.
- Started
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Oct 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 to 84 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject has provided informed consent for participation in trial. 2. Subject is male or female, aged 50 or older but younger than 85. 1. Female Subjects: * Of child-bearing potential in the age range of 50-60 years who are still menstruating, are willing to perform a pregnancy test at screening visit, V1 (Baseline) and at each subsequent visit and adhere to contraception requirements. * Of nonchildbearing Potential (WONCBP), women in the following categories are considered WONCBP: Premenopausal female permanently sterile due to one of the following (for the purpose of this study): Women who have documented hysterectomy, documented bilateral salpingectomy, documented bilateral oophorectomy * Postmenopausal female is defined as no menses for 12 months. If confirmation is needed, a high follicle stimulating hormone (FSH) level in the postmenopausal range will be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). Females on HRT and whose menopausal status is in doubt must discontinue HRT to allow confirmation of postmenopausal status before study enrollment. 2. Male subjects: * Male subjects with female partners of child-bearing potential who are willing or able to adhere to contraception requirements, or male subjects with documented infertility. 3. 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). 4. Subject has an MMSE score of \>21 \< 28 5. Subject is willing to have a baseline and follow up blood tests according to the schedule of assessments, for up to 12 months. 6. Subject has a pTau 217 value of \> 0.35 pg/ml 7. Subject is willing and able to undergo MRI, and amyloid PET scan evaluations of the brain, which fulfill the following requirements: 1. PET amyloid brain load \>32 centiloids 2. MRI \<8 micro bleeds 8. Subject has a spouse/close relative/caregiver as study partner who lives with him/her or supervises subject care. The caregiver must be willing to accompany the subject to all study visits and able to give informed consent for their own participation and be able to read and write. 9. If taking concomitant medications, treated with stable doses of drugs essentially required for chronic medical conditions which do not lead to exclusion, during a period of at least 3 months prior to screening, and dose regimen is expected to remain stable during the conduct of the study. 10. Subject is able to read, write, speak clearly for the cognitive tests, with eyesight and hearing sufficient to enable completion of the cognitive tests. Exclusion Criteria: 1. Subject has MRI evidence evaluated by central read of 1. 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. 2. 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. 2. Subject has moderate or severe dementia, defined as CDR of ≥ 2.0 3. 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. 4. Subject has known sensitivity to NAC/NACA. 5. Known or recently suspected (3 months) excessive alcohol or drug abuse. 6. History of liver disease. 7. There is any concern by the investigator regarding the subject's safety, compliance, or suitability with respect to his/her participation in the study. 8. Use of NAC or other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 14 days, whichever is longer. 9. Subjects who are or have been on AD immunotherapy. 10. Any suicidal ideation or suicidal behavior in the C-SSRS (C-SSRS score \> 0)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Landspitali University Hospital
Reykjavik, 108, Iceland
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Sanos Clinic Gandrup
Gandrup, Denmark
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Sanos Clinic Herlev
Herlev, Denmark
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Sanos Clinic Vejle
Vejle, Denmark
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