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

NCT07741526 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-08-03

No results posted yet for this 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.

Conditions

  • Alzheimer´s Disease

Interventions

DRUG

NPI-001

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Blueskin AS

    collaborator INDUSTRY

  • Arctic Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2027-04-30
Completion
2027-05-31

Countries

  • Denmark
  • Iceland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07741526 on ClinicalTrials.gov