Efficacy and Safety of NVP-NK4146 in Patients with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
36-week, Single-center, Randomized, Double-blind, Parallel-design, Placebo-controlled Trial to Determine the Safety and Efficacy of NVP-NK4146 in Patients with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
1 other identifier
interventional
60
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable alzheimer-disease
Started Apr 2025
Shorter than P25 for not_applicable alzheimer-disease
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2024
CompletedFirst Posted
Study publicly available on registry
January 7, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedJanuary 13, 2025
December 1, 2024
12 months
December 17, 2024
January 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
amyloid PET scan
Changes in brain amyloid measured by amyloid PET scan from baseline to 36 weeks
baseline and 36 weeks
Secondary Outcomes (4)
ADAS-Cog(Alzheimer's Disease Assessment Scale-Cognitive Subscale)13
baseline and 36 weeks
CDR-SB(Clinical Dementia Rating-Sum of Boxes)
baseline and 36 weeks
GDS (Global Deterioration Scale)
baseline and 36 weeks
K-MMSE (the Korean Mini-Mental State Examination)
baseline and 36 weeks
Study Arms (2)
Active Group
EXPERIMENTALNVP-NK4146
Placebo Group
PLACEBO COMPARATORNVP-NK4146 Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Male and female adults aged 60 or older
- 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
- 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
You may not qualify if:
- Subject diagnosed with dementia according to the criteria of DSM-5 or ICD-10
- 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)
- Subject who are illiterate and/or without any education
- Any other factors deemed by the investigator to be likely to ineligible for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NVP Healthcarelead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2024
First Posted
January 7, 2025
Study Start
April 1, 2025
Primary Completion
March 31, 2026
Study Completion
April 30, 2026
Last Updated
January 13, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share