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Safety, Tolerability and Biomarker-based Efficacy of NPI-001 (AT-001) in Subjects with Alzheimer’s Disease (AD)
EU CTIS ID: 2024-519497-39-00
What this study is testing
To assess safety and tolerability in response to NPI-001 (AT-001) administered orally in patients with Alzheimer’s disease (AD). MRI imaging to assess ARIA H and ARIA E in the brain
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject is male or female, aged 50 or older but younger than 85.
- Subject has a pTau 217 value of > 0.35 pg/ml
- 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
- Subject is willing to have a baseline and follow up blood tests according to the schedule of assessments, for up to 12 months.
- Subject is willing and able to undergo MRI, and amyloid PET scan evaluations of the brain which fulfil the following requirements:a.PET amyloid brain load >32 centiloids b. MRI <8 micro bleeds.
- Subject has provided informed consent for participation in trial.
You likely can't join if
- Subject has MRI evidence evaluated by central read of a. 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. b. 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.
- Known or recently suspected (3 months) excessive alcohol or drug abuse.
- There is any concern by the investigator regarding the patient’s safety, compliance, or suitability with respect to his/her participation in the study.
- 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.
- Subject has moderate or severe dementia, defined as CDR of ≥ 2.0
- History of liver disease
See the full eligibility criteria
Who can join
- Subject is male or female, aged 50 or older but younger than 85.
- Subject has a pTau 217 value of > 0.35 pg/ml
- 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
- Subject is willing to have a baseline and follow up blood tests according to the schedule of assessments, for up to 12 months.
- Subject is willing and able to undergo MRI, and amyloid PET scan evaluations of the brain which fulfil the following requirements:a.PET amyloid brain load >32 centiloids b. MRI <8 micro bleeds.
- Subject has provided informed consent for participation in trial.
- Subject has a spouse/close relative/caregiver as study partner who lives with or supervises subject care.
- Subject has an MMSE score of >21 < 28
- 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.
- Subject is able to read, write, speak clearly for the cognitive tests, with eyesight and hearing sufficient to enable completion of the cognitive tests.
What rules you out
- Subject has MRI evidence evaluated by central read of a. 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. b. 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.
- Known or recently suspected (3 months) excessive alcohol or drug abuse.
- There is any concern by the investigator regarding the patient’s safety, compliance, or suitability with respect to his/her participation in the study.
- 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.
- Subject has moderate or severe dementia, defined as CDR of ≥ 2.0
- History of liver disease
- Any suicidal ideation or suicidal behavior in the C-SSRS (C-SSRS score > 0)
- Subjects who are or have been on AD immunotherapy.
- Subject has MRI evidence of vascular disease (vascular dementia).
- 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 patient by their participation, or prevent/impede the patient from completing the study.
- Subject has known sensitivity to NAC/NACA.
The study team makes the final eligibility decision.
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.