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Enrolling by invitationNCT06761066Updated Sep 1, 2026

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

An interventional study of NVP-NK4146 and NVP-NK4146 Placebo in Alzheimer Disease, sponsored by NVP Healthcare. Enrolling by invitation at 1 site in South Korea. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by NVP Healthcare · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

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

Read the detailed description

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

02

Conditions studied

  • Alzheimer Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

NVP Healthcare is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Active Group

    NVP-NK4146

    Dietary Supplement: NVP-NK4146

  • Placebo comparator
    Placebo Group

    NVP-NK4146 Placebo

    Dietary Supplement: NVP-NK4146 Placebo

Interventions

  • Dietary supplementNVP-NK4146

    BID for 36 weeks orally

  • Dietary supplementNVP-NK4146 Placebo

    BID for 36 weeks orally

06

What researchers measure

Primary outcomes

  1. amyloid PET scan

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

    Time frame: baseline and 36 weeks

Secondary outcomes

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

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

    Time frame: baseline and 36 weeks

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

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

    Time frame: baseline and 36 weeks

  3. GDS (Global Deterioration Scale)

    Change in GDS total score from baseline to 36 weeks

    Time frame: baseline and 36 weeks

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

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

    Time frame: baseline and 36 weeks

07

Study locations

1 site
  • The Catholic University of Korea Yeouido St. Mary's Hospital
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06761066
Lead sponsor
NVP Healthcare
Responsible party
Sponsor
First posted
Jan 7, 2025
Start date
Jan 20, 2026
Primary completion
Sep 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Sep 1, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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