Alzheimer DiseaseNCT06761066
Efficacy and Safety of NVP-NK4146 in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
A study testing NVP-NK4146 in people with Alzheimer Disease, run by NVP Healthcare at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- NVP-NK4146
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jan 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
The Catholic University of Korea Yeouido St. Mary's Hospital
Seoul
About this study
Official 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
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
- Conditions
- Alzheimer Disease
- Being tested
- NVP-NK4146, NVP-NK4146 Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVP-NK4146Dietary supplement
BID for 36 weeks orally
NVP-NK4146 PlaceboDietary supplement
BID for 36 weeks orally
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | NVP-NK4146 Receives: Dietary Supplement: NVP-NK4146 |
| Placebo Group | Placebo comparator | NVP-NK4146 Placebo Receives: Dietary Supplement: NVP-NK4146 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
amyloid PET scan
Changes in brain amyloid measured by amyloid PET scan from baseline to 36 weeks
Measured: baseline and 36 weeks
Secondary outcomes (4)
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
Measured: baseline and 36 weeks
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
Measured: baseline and 36 weeks
GDS (Global Deterioration Scale)
Change in GDS total score from baseline to 36 weeks
Measured: baseline and 36 weeks
K-MMSE (the Korean Mini-Mental State Examination)
Change in K-MMSE total score from baseline to 36 weeks
Measured: baseline and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start20 Jan 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NVP Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761066
- Sponsor's protocol ID
- NVP-NK4146_HS
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06761066
- Acronym / sponsor ID
- NVP-NK4146_HS
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NVP HealthcareIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Dietary Supplement: NVP-NK4146NVP-NK4146 |
| Placebo Group | Placebo comparator | Dietary Supplement: NVP-NK4146 PlaceboNVP-NK4146 Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVP-NK4146BID for 36 weeks orally | Dietary supplement | Active Group |
| NVP-NK4146 PlaceboBID for 36 weeks orally | Dietary supplement | Placebo Group |
Primary outcome
amyloid PET scan
Time frame: baseline and 36 weeks
Changes in brain amyloid measured by amyloid PET scan from baseline to 36 weeks
4 secondary outcomes
ADAS-Cog(Alzheimer's Disease Assessment Scale-Cognitive Subscale)13
Time frame: baseline and 36 weeks
CDR-SB(Clinical Dementia Rating-Sum of Boxes)
Time frame: baseline and 36 weeks
GDS (Global Deterioration Scale)
Time frame: baseline and 36 weeks
K-MMSE (the Korean Mini-Mental State Examination)
Time frame: baseline and 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NVP-NK4146 in people with Alzheimer Disease, run by NVP Healthcare at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amyloid PET scan (time frame: baseline and 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.