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

Not Applicable

Not yet recruiting

• Conditions: Alzheimer Disease

• Registration Number: NCT06761066
• Lead Sponsor: NVP Healthcare

Brief 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

Detailed Description

36-week, single-center, randomized, double-blind, parallel-design, placebo-controlled trial

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2025-01-04
• Study First Posted: 2025-01-07
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13
• Study Start: 2025-04-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
amyloid PET scan	baseline and 36 weeks	Changes in brain amyloid measured by amyloid PET scan from baseline to 36 weeks

Secondary Outcome Measures

Name	Time	Method
GDS (Global Deterioration Scale)	baseline and 36 weeks	Change in GDS total score from baseline to 36 weeks
K-MMSE (the Korean Mini-Mental State Examination)	baseline and 36 weeks	Change in K-MMSE total score from baseline to 36 weeks
ADAS-Cog(Alzheimer's Disease Assessment Scale-Cognitive Subscale)13	baseline and 36 weeks	Changes in ADAS-Cog 13 total score, memory score, and subscales from baseline to 36 weeks
CDR-SB(Clinical Dementia Rating-Sum of Boxes)	baseline and 36 weeks	Changes in CDR-SB(Clinical Dementia Rating-Sum of Boxes) and CDR total score from baseline to 36 weeks