Effect of FGUE on the Mild Cognitive Impairment for the Efficacy and Safety; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Impairment for the Efficacy and Safety; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003016

Enrollment

Registered

2018-07-24

Start date

2016-12-23

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement, Others : Subjects will be randomized to receive FGUE capsule 1g or placebo. Subjects will orally self-adminster FGUE capsule 1g or placebo twice a day, 2 capsules per day for 12we

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - A person who complain of memory loss and demonstrate a decrease of 1.0 SD or more on CERAD-K (Consortium to Establish a Registry for Alzheimer's Disease-Korean version)

Exclusion criteria

Exclusion criteria: - People who are currently suffering from schizophrenia or have a history of schizophrenia - People who have major depressive disorders categorized by DSM-V(The Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition) - People who have poor cognitive function and have Alzheimer’s disease, Parkinson’s disease, or stroke. (The diagnosis of Alzheimer’s disease is based on DSM-V) - People who have taken medications for Alzheimer’s disease or other cognitive function problems within 4 weeks prior to the first visit of the study. The examples of the medications are Antipsycotics, Neurodegenerative Disease Drugs, Nootropics & Neurotonics, and tricyclic antidepressant.

Design outcomes

Primary

Measure	Time frame
Changes in the scores of ADAS-cog(Cognitive subscale of the ADAS) between baseline and after 12 weeks of the treatment	—

Secondary

Measure	Time frame
Changes in the scores of ADAS-cog(Cognitive subscale of the ADAS) memory between baseline and after 12 weeks of the treatment;Changes in the scores of ADAS-K(Alzheimer’s Disease Assessment Scale-Korean version) between baseline and after 12 weeks of the treatment;Changes in the scores of Visual C.P.T(Visual continuous performance test) between baseline and after 12 weeks of the treatment;Changes in the scores of ADCS-ADL(Alzheimer’s Disease Cooperative Study-Activities of Daily Living) between baseline and after 12 weeks of the treatment;Changes in the scores of SGDS(Short form of Geriatric Depression Scale)? Sheikh? Yesavage) between baseline and after 12 weeks of the treatment	—

Measure

Time frame

Changes in the scores of ADAS-cog(Cognitive subscale of the ADAS) memory between baseline and after 12 weeks of the treatment;Changes in the scores of ADAS-K(Alzheimer’s Disease Assessment Scale-Korean version) between baseline and after 12 weeks of the treatment;Changes in the scores of Visual C.P.T(Visual continuous performance test) between baseline and after 12 weeks of the treatment;Changes in the scores of ADCS-ADL(Alzheimer’s Disease Cooperative Study-Activities of Daily Living) between baseline and after 12 weeks of the treatment;Changes in the scores of SGDS(Short form of Geriatric Depression Scale)? Sheikh? Yesavage) between baseline and after 12 weeks of the treatment

—

Countries

Korea, Republic of

Contacts

Public Contactjongwoo

Kyung Hee University Hospital

paikjw@gmail.com+82-2-958-8419

Outcome results