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

NVP Healthcare

Status: Not yet enrolling

Conditions: Alzheimer Disease

Treatments: Dietary Supplement: NVP-NK4146; Dietary Supplement: NVP-NK4146 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06761066

NVP-NK4146_HS

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Active Group

Experimental group

Description:

NVP-NK4146

Treatment:

Dietary Supplement: NVP-NK4146

Placebo Group

Placebo Comparator group

Description:

NVP-NK4146 Placebo

Treatment:

Dietary Supplement: NVP-NK4146 Placebo