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Effect of HLJG0701 on the Mild Cognitive Impairment for the Efficacy and Safety; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Effect of HLJG0701 on the Mild Cognitive Impairment for the Efficacy and Safety; A 12week, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003010
Enrollment
80
Registered
2018-07-21
Start date
2017-03-08
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 : Subjects will be randomized to receive HLJG0701 capsule 1.5g or placebo. Subjects will orally self-adminster HLJG0701 1.5g or placebo twice, 8 capsule per day for 12weeks.

Sponsors

Hwajin
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subject who have decreased CERAD-K(Consortium to Establish a Registry for Alzheimer’s Disease-Korean version) memory score(1.0SD<= and 2.0SD < CERAD-K memory score) comparing to the same age and education group.

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

MeasureTime frame
Changes in the scores of VLT(Verbal learning test) between baseline and after 12 weeks of the treatment;Changes in the scores of NORT(Novel Object Recognition Test) between baseline and after 12 weeks of the treatment;Changes in the scores of Story Recall Test between baseline and after 12 weeks of the treatment;Changes in the scores of Digit span test(Digit span Forward, Digit span Backward) between baseline and after 12 weeks of the treatment

Secondary

MeasureTime frame
Changes in the scores of Auditory Continuous Performance Test between baseline and after 12 weeks of the treatment;Changes in the scores of PRMQ(Prospective and Retrospective Memory Questionnaire) between baseline and after 6, 12 weeks of the treatment;Changes in the scores of PSS(Perceived stress Scale) between baseline and after 6, 12 weeks of the treatment;Changes in the scores of BDNF(Brain-Derived Neurotrophic Factor) between baseline and after screening(-2~0), 12 weeks of the treatment

Countries

Korea, Republic of

Contacts

Public Contactyeongchul chung

Chonbuk National University Hospital

realycchung@naver.com+82-63-250-2185

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026