A 12 Week, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of NVP-2106 on improvement of Cognitive Function

VP Healthcare0 sites120 target enrollmentTBD

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: VP Healthcare
Enrollment: 120
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

November 14, 2023

Last Updated

2 years ago

Study Type

Interventional Study

Sex

All

Investigators

Sponsor

VP Healthcare

Eligibility Criteria

Inclusion Criteria

•1\) Adult men and women who are 60 years of age or older at the time of screening and complain of memory decline
•2\) Those whose CERAD\-K word list memory/recall/recognition test score decreased by 1\-2 SD from the normal value (those who satisfy at least 1 of the 3 items above)
•3\) Those with a total score of 22 or less on the Korean version of the Montreal Cognitive Assessment (MOCA\-K)
•4\) A person who, after hearing and fully understanding the detailed explanation of this human application test, voluntarily decides to participate and agrees in writing to comply with the precautions

Exclusion Criteria

•1\) Those who are currently treated with DSM\-IV Axis I Disorders in Structured Clinical Interview for DSM\-IV (SCID) conducted at the time of the screening test or have a history of being treated within the last three years.
•2\) A person who has continuously consumed lactobacillus formulation (or probiotic formulation) and fermented dairy products (yogurt, cheese, etc.) within 2 weeks prior to the screening test (four times or more/week).
•3\) A person who has alcohol abuse or dependence within three months prior to a screening test.
•4\) Those with clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatometer, kidney and urinary system, neuropsychiatric system, musculoskeletal system, inflammatory and blood and oncogenic, gastrointestinal disease, etc. that require treatment.
•5\) A person who has taken drugs, health functional foods or herbal medicines related to cognitive and memory improvement within one month prior to a screening test (see prohibited drugs).
•6\) A person who has taken psychiatric drugs such as antipsychotic drugs, antidepressants, mood control agents, sleeping pills, and anti\-anxiety drugs within one month prior to a screening test.
•7\) Those who have taken antibiotics within four weeks prior to a screening test.
•8\) A person who has donated whole blood within one month before the screening test or donated ingredients within two weeks.
•9\) A person who has participated in another human body application test within three months prior to the screening test.
•10\) Those who show the following results in diagnostic tests and medical tests.