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

NCT ID: NCT06761066

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-04-30

Brief Summary

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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

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

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Group

NVP-NK4146

Group Type EXPERIMENTAL

NVP-NK4146

Intervention Type DIETARY_SUPPLEMENT

BID for 36 weeks orally

Placebo Group

NVP-NK4146 Placebo

Group Type PLACEBO_COMPARATOR

NVP-NK4146 Placebo

Intervention Type DIETARY_SUPPLEMENT

BID for 36 weeks orally

Interventions

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NVP-NK4146

BID for 36 weeks orally

Intervention Type DIETARY_SUPPLEMENT

NVP-NK4146 Placebo

BID for 36 weeks orally

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NVP Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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

Role: CONTACT

+82-2-3779-1880

Other Identifiers

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NVP-NK4146_HS

Identifier Type: -

Identifier Source: org_study_id

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