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NCT Number: NCT06761066

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

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

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

NVP-NK4146

Dietary Supplement

BID for 36 weeks orally

NVP-NK4146 Placebo

Dietary Supplement

BID for 36 weeks orally

Primary outcomes

  1. amyloid PET scan

    Time frame: baseline and 36 weeks

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

Secondary outcomes

  1. ADAS-Cog(Alzheimer's Disease Assessment Scale-Cognitive Subscale)13

    Time frame: baseline and 36 weeks

    Changes in ADAS-Cog 13 total score, memory score, and subscales from baseline to 36 weeks

  2. CDR-SB(Clinical Dementia Rating-Sum of Boxes)

    Time frame: baseline and 36 weeks

    Changes in CDR-SB(Clinical Dementia Rating-Sum of Boxes) and CDR total score from baseline to 36 weeks

  3. GDS (Global Deterioration Scale)

    Time frame: baseline and 36 weeks

    Change in GDS total score from baseline to 36 weeks

  4. K-MMSE (the Korean Mini-Mental State Examination)

    Time frame: baseline and 36 weeks

    Change in K-MMSE total score from baseline to 36 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Hyun Kook Lim, M.D./Ph.D.

CONTACT

[email protected]

+82-2-3779-1880

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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