A Human Study to Evaluate the Efficacy and Safety of Hericium erinaceus Extract Powder for Memory Improvement

A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Hericium erinaceus Extract Powder for the Improvement of Memory Function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012355

Enrollment

Registered

2026-07-30

Start date

2025-03-27

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

None listed

Interventions

Others(Health Functional Food Ingredient) : Test Food Group(Hericium erinaceus Extract Powder) consists primarily of Hericium erinaceus powder, containing 500 mg per tablet. Participants will be instr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Men and women aged 55 to 74 years. 2) Participants with a subjective memory complaints, defined as a Korean Mini-Mental State Examination(K-MMSE) score =24 and an Subjective Memory Complaints Questionnaire(SMCQ) score =1

Exclusion criteria

Exclusion criteria: 1) Participants with severe cerebrovascular disease (e.g., cerebral infarction or cerebral hemorrhage), cardiovascular disease (e.g., angina pectoris, myocardial infarction, heart failure, or arrhythmia requiring treatment), or malignancy within the previous 6 months. Participants with a history of cerebrovascular or cardiovascular disease who are considered clinically stable may be enrolled at the investigator's discretion. 2) Participants with a current diagnosis or history of schizophrenia. 3) Participants with a Korean Short Form Geriatric Depression Scale(SGDS-K) score of =10. 4) Participants with diseases associated with cognitive impairment, such as dementia, Parkinson's disease, or cerebral infarction. Dementia shall be diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5) criteria. 5) Participants with a clinically significant psychiatric history or current psychiatric disorder (e.g., schizophrenia or epilepsy), or a history of alcohol or substance abuse. 6) Participants diagnosed with a neuropsychiatric disorder within 3 months prior to Visit 1. 7) Participants who have taken medications for neuropsychiatric disorders within 4 weeks prior to Visit 1. 8) Participants who have taken medications or health functional foods that may affect cognitive function or memory (e.g., antipsychotics, anti-dementia drugs, cognitive enhancers, or tricyclic antidepressants) within 4 weeks prior to Visit 1. 9) Participants receiving ongoing treatment or medication for gastrointestinal disorders (e.g., gastric ulcer, chronic dyspepsia, or irritable bowel syndrome). 10) Participants with aspartate aminotransferase(AST) or alanine aminotransferase(ALT) levels =2.5 times the upper limit of normal(ULN) at the study site. 11) Participants with serum creatinine levels =2.0 times the upper limit of normal (ULN) at the study site. 12) Participants with uncontrolled diabetes mellitus (fasting blood glucose =180 mg/dL) or uncontrolled hypertension (blood pressure =160/100 mmHg after at least 10 minutes of rest at screening).

Design outcomes

Primary

Measure	Time frame
Total score on the Alzheimer's Disease Assessment Scale–Cognitive Subscale 13-item version (ADAS-Cog 13);Safety outcome(Adverse event, Laboratory Test Parameters, Vital sign)	—

Secondary

Measure	Time frame
Memory, language, and praxis domain scores of the Alzheimer's Disease Assessment Scale–Cognitive Subscale, 13-item version (ADAS-Cog 13);Korean Mini-Mental State Examination (K-MMSE) total score;Total score of Subjective Memory Complaints Questionnaire (SMCQ)	—

Countries

Korea, Republic of

Contacts

Public ContactHooWon Kim

Chosun University Hospital

hoowon@chosun.ac.kr+82-62-220-3128

Outcome results