Efficacy and Safety of NVP-NK4146 in Patients with Mild C... | NCT06761066

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

NCT06761066

Sponsor

NVP Healthcare

Status

Not yet recruiting

Last Update Posted

Jan 13, 2025Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Alzheimer Disease

Interventions

NVP-NK4146
NVP-NK4146 Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2025Estimated

Primary Completion Date

Mar 31, 2026Estimated

Completion Date

Apr 30, 2026Estimated

First Submitted Date

Dec 17, 2024

First Submission Date that Met QC Criteria

Jan 4, 2025

First Posted Date

Jan 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2025

Last Update Posted Date

Jan 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Group	Experimental	NVP-NK4146	Dietary Supplement: NVP-NK4146
Placebo Group	Placebo Comparator	NVP-NK4146 Placebo	Dietary Supplement: NVP-NK4146 Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NVP-NK4146	Dietary Supplement	BID for 36 weeks orally	Active Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
amyloid PET scan	Changes in brain amyloid measured by amyloid PET scan from baseline to 36 weeks	baseline and 36 weeks

Secondary Outcomes

Measure	Description	Time Frame
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	baseline and 36 weeks
CDR-SB(Clinical Dementia Rating-Sum of Boxes)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Hyun Kook Lim, M.D./Ph.D.	Contact	+82-2-3779-1880		drblues@catholic.ac.kr

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided