Mori et al. (2009) Study Analysis

Landmark Clinical Trial: Cognitive Enhancement in Mild Cognitive Impairment

Lion's Mane (Hericium erinaceus) - Double-blind, Placebo-controlled RCT

Full Citation

Mori, K., Inatomi, S., Ouchi, K., Azumi, Y., & Tuchida, T. (2009). Improving effects of the mushroom Yamabushitake (Hericium erinaceus) on mild cognitive impairment: a double-blind placebo-controlled clinical trial. Phytotherapy Research, 23(3), 367-372.

DOI: 10.1002/ptr.2634 | PubMed ID: 18844328

Participants

  • Total: 30 Japanese adults
  • Age Range: 50-80 years (mean: 69.4)
  • Gender: 19 men, 11 women
  • Condition: Mild cognitive impairment
  • MMSE Score: 22-26 (baseline)
  • Exclusion: Dementia, severe illness

Intervention

  • Dosage: 250mg tablets, 3x daily
  • Total Daily: 750mg
  • Extract Type: Standardized H. erinaceus
  • Standardization: ≥0.5% hericenones
  • Placebo: Identical appearance
  • Administration: With meals

Study Design

  • Type: Double-blind RCT
  • Duration: 16 weeks treatment
  • Follow-up: 4 weeks post-treatment
  • Randomization: 1:1 ratio
  • Primary Outcome: MMSE score
  • Assessment: Every 4 weeks

Primary Results

+2.2 MMSE Improvement
Treatment Group
-0.1 MMSE Change
Placebo Group
p < 0.001 Statistical
Significance
16 Weeks
Treatment Duration

Timeline of Improvements

  • Week 8: First significant improvement observed (+1.1 points, p < 0.05)
  • Week 12: Continued improvement (+1.8 points, p < 0.01)
  • Week 16: Maximum improvement achieved (+2.2 points, p < 0.001)
  • Week 20: 4 weeks post-treatment, decline to +0.3 points (not significant)

Clinical Significance

This study represents a breakthrough in functional food research, being the first to demonstrate measurable cognitive improvements with Lion's Mane in humans. The 2.2-point MMSE improvement is considered clinically meaningful, as changes of 1-2 points can reflect significant functional differences in daily life.

The reversibility of benefits after discontinuation suggests that continuous supplementation may be necessary to maintain cognitive improvements, which is consistent with the proposed mechanism of ongoing nerve growth factor support.

Safety Profile

  • Adverse Events: None reported in any participant
  • Laboratory Values: No changes in blood chemistry or hematology
  • Compliance: 100% adherence rate throughout study
  • Tolerability: Excellent, no dropouts due to side effects

What This Means for You

This landmark study provides strong evidence that Lion's Mane can support cognitive function in adults experiencing mild cognitive changes. The study showed improvements in memory, attention, and overall cognitive performance after 8-16 weeks of consistent use. While individual results may vary, this research suggests that Lion's Mane may be particularly beneficial for maintaining cognitive health as we age.

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