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Active, not recruitingNCT07741526AD BiomarkerUpdated Aug 3, 2026

Safety, Tolerability and Biomarker-based Efficacy of NPI-001 (AT-001) in Subjects With MCI or Alzheimer's Disease (AD)

A Phase 2 interventional study of NPI-001 and Placebo in Alzheimer´s Disease, sponsored by Arctic Therapeutics. Active, not recruiting at 4 sites in 2 countries. Open to participants aged 50 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Arctic Therapeutics · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2025, registered Mar 2026).

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Phase
Phase 2
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
50 Years to 84 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 61 studies in Cognitive Dysfunction with a site in Denmark — 14 open to participants now, 20 under way, 2 of them phase 3. Cognitive Dysfunction · Denmark.

Enrollment
24th of 32
33 · median 70
Started
2025
with 5 others
Phase 2
6 of 61
none open now
Primary completion
2027-04
later than 8 of 19 live
Registered
60th of 61
by date

Among the 61 studies in Cognitive Dysfunction with a site in Denmark, this one is the 24th largest by enrollment of the 32 interventional ones that give a count, is one of 6 that started in 2025, is one of 6 in phase 2, reaches primary completion later than 8 of the 19 other live ones, and was the 60th registered.

Cognitive Dysfunction

3,876 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

Browse Cognitive Dysfunction studies →

Open to participants now

14 of the 61 studies in Cognitive Dysfunction with a site in Denmark are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →

Who these studies take

Of the 753 Cognitive Dysfunction studies recruiting now, 364 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 260 take healthy volunteers.

This study: 50 Years to 84 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Alzheimer´s Disease

Keywords

  • Alzheimer´s disease
  • Mild Cognitive Impairment
  • Dementia
04

Who can participate

Ages eligible
50 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject has provided for participation in trial.

  2. Subject is male or female, aged 50 or older but younger than 85.

    1. Female Subjects:

      • Of 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 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
      • 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 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

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 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 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)
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Active treatment + SOC

    The group receives increasing dose of the active treatment and SOC

    Drug: NPI-001

  • Placebo comparator
    Placebo + SOC

    The group receives dose of the placebo and SOC

    Drug: Placebo

Interventions

  • DrugNPI-001

    NPI-001 tablets administered orally BID at escalating doses of 250 mg, 500 mg, and 750 mg for period of 12 months

  • DrugPlacebo

    Placebo tablets administered orally BID at escalating doses of 250 mg, 500 mg, and 750 mg for period of 12 months

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment -Emergent Adverse Events

    Incidence of Treatment -Emergent Adverse Events in response to NPI (AT-001) administered orally in subjects with Alzheimer's disease (AD). Assessment of the number of participants with treatment-related adverse events. Assessment of the amount of mild and severe adverse events related to the treatment.

    Time frame: Through study completion, approximately up to 14 months

  2. Safety labs results within normal range

    Safety labs result not being outside of normal ranges and/or not clinically significant as assessed by the PI.

    Time frame: Through study completion, approximately up to 14 months

  3. Assessment of ARIA H and ARIA E in the brain with MRI imaging

    MRI imaging to assess ARIA H and ARIA E in the brain by ARIA MRI classification.

    Time frame: Through study completion, approximately up to 14 months

Secondary outcomes

  1. Biomarker 1: Assessment of reduction in toxic amyloid oligomers in plasma samples

    Reduction in toxic amyloid oligomers in plasma samples at 3, 6, 9 and 12 months of therapy measured by SOBA method.

    Time frame: Through study completion, until 12 months

  2. Biomarker 2: Assessment of the effects of NPI-001 on pTau217 levels in plasma

    Reduction in pTau217 in plasma samples at 3, 6, 9 and 12 months of therapy measured by Simoa technology.

    Time frame: Through study completion, until 12 months

  3. Biomarker 3: Assessment of the effects of NPI-001 on NFL in plasma

    Reduction in NFL in plasma samples at 3, 6, 9 and 12 months of therapy assessed by ELISA.

    Time frame: Through study completion, until 12 months

  4. Biomarker 4: Assessment of reduction in amyloid accumulation in the brain following 12 months of therapy (PET)

    To determine if any reduction/reversal of amyloid accumulation in the brain of subjects with AD in response to NPI-001, administered orally.

    Time frame: Through study completion, until 12 months

07

Study locations

4 sites
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Apr 2027, 18 months after the start.

Of 41 industry-sponsored phase 2 interventional studies under Cognitive Dysfunction, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 39. This study's planned 18 months is below that.

Counting every sponsor, half of 186 studies reached it within 42 months; a quarter within 22 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2026
First posted
Aug 3, 2026
StartActual
Oct 14, 2025
Primary completionEst.
Apr 30, 2027
CompletionEst.
May 31, 2027
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07741526
Lead sponsor
Arctic Therapeutics
Collaborators
Blueskin AS
Responsible party
Sponsor
First posted
Aug 3, 2026
Start date
Oct 14, 2025
Primary completion
Apr 30, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Aug 3, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: NPI-001

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