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Enrolling by invitation Not applicable

Efficacy and Safety of NVP-NK4146 in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

NCT06761066 · tracked via the Priya Life Science South Korea tracker
Sponsor
NVP Healthcare
Phase
Not applicable
Started
2026-01-20
Last updated
2026-09-01

Condition(s) studied

Alzheimer Disease

Investigational drug(s) / intervention(s)

NVP-NK4146NVP-NK4146 Placebo

NVP-NK4146: BID for 36 weeks orally

NVP-NK4146 Placebo: BID for 36 weeks orally

Study summary

The purpose of this clinical trial is to exploratively evaluate the efficacy and safety of NVP -NK4146 in improving mild cognitive impairment (MCI) in patients with due to Alzheimer's disease (AD) compared to placebo

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Male and female adults aged 60 or older 2. Subject who meet the National Institute of Aging and Alzheimer's Associations (NIA-AA) core clinical criteria for MCI and have positive readings from amyloid PET 3. Subject who can read and understand the Informed Consent Form and legends and who voluntarily decided to participate in current clinical trial and have signed the Informed Consent Form Exclusion Criteria: 1. Subject diagnosed with dementia according to the criteria of DSM-5 or ICD-10 2. Subject currently receiving treatment for malignant tumors (except those who have fully recovered from cancer for more than 5 years or those with basal cell carcinoma, squamous cell carcinoma, or prostate cancer may participate at the investigator's discretion) 3. Subject who are illiterate and/or without any education 4. Any other factors deemed by the investigator to be likely to ineligible for the study

Primary outcome measure(s)

  • amyloid PET scan — baseline and 36 weeks
    Changes in brain amyloid measured by amyloid PET scan from baseline to 36 weeks

Trial sites (1)

FacilityCityRegionStatus
The Catholic University of Korea Yeouido St. Mary's Hospital Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06761066 on ClinicalTrials.gov ↗ ← All trials in South Korea