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

Enrolling By InvitationNA

Sponsor: NVP Healthcare

Conditions: Alzheimer Disease

Interventions: NVP-NK4146, NVP-NK4146 Placebo

Countries: South Korea

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

Eligibility overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Seoul, South Korea