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ACTIVE NOT RECRUITING
NCT07741526
PHASE2

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

Sponsor: Arctic Therapeutics

View on ClinicalTrials.gov

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.

Official title: A Phase 2a Multi-site, Randomized, Double-blind, Dose Escalated, Placebo Controlled Biomarker Study to Determine the Safety, Tolerability and Biomarker-based Efficacy of NPI-001 (AT-001) in Subjects With MCI (Mild Cognitive Impairment) or Mild Dementia Due to Alzheimer's Disease (AD) Aged 50 to 85 Years

Key Details

Gender

All

Age Range

50 Years - 84 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2025-10-14

Completion Date

2027-05-31

Last Updated

2026-08-03

Healthy Volunteers

No

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

Locations (4)

Sanos Clinic Gandrup

Gandrup, Denmark

Sanos Clinic Herlev

Herlev, Denmark

Sanos Clinic Vejle

Vejle, Denmark

Landspitali University Hospital

Reykjavik, Iceland