Alzheimer Disease
Conditions
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
Interventions
DIETARY_SUPPLEMENTNVP-NK4146
BID for 36 weeks orally
DIETARY_SUPPLEMENTNVP-NK4146 Placebo
BID for 36 weeks orally
Sponsors
NVP Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| amyloid PET scan | baseline and 36 weeks | Changes in brain amyloid measured by amyloid PET scan from baseline to 36 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| K-MMSE (the Korean Mini-Mental State Examination) | baseline and 36 weeks | Change in K-MMSE total score from baseline to 36 weeks |
| GDS (Global Deterioration Scale) | baseline and 36 weeks | Change in GDS total score from baseline to 36 weeks |
| ADAS-Cog(Alzheimer's Disease Assessment Scale-Cognitive Subscale)13 | baseline and 36 weeks | Changes in ADAS-Cog 13 total score, memory score, and subscales from baseline to 36 weeks |
| CDR-SB(Clinical Dementia Rating-Sum of Boxes) | baseline and 36 weeks | Changes in CDR-SB(Clinical Dementia Rating-Sum of Boxes) and CDR total score from baseline to 36 weeks |
Countries
South Korea
Outcome results
None listed