Table 2.

Clinical studies of Hericium erinaceus in AD individuals.

Authors	Disease, Clinical Phase, and Duration	Research Design	Administration Method	Dosage	Outcome Measures	Clinical Evaluation	Adverse Effects
Li et al., 2020 [60]	Mild Alzheimer’s disease Completed 52 weeks	Double-blind, two parallel groups, randomized, placebo-controlled 49 participants, 50 to 90 years old	Oral route	350 mg mycelia-based capsule containing 5 mg/g of erinacine A per day or identically appearing placebo capsules	Significant improvement in MMSE, IADL, CASI scores, and better contrast sensitivity than placebo HE-A was well-tolerated, safe, and improved cognitive function	Adverse events evaluation NPI MMSE CASI IADL Ophthalmic examination Biomarker collection Neuroimaging	1 subject lost to follow-up 3 subjects lost to unsatisfactory efficacy 4 subjects lost to side effects: nausea, abdominal discomfort, nausea, and skin rash
Mori et al., 2009 [61]	Mild cognitive impairment Completed 22 weeks	Double-blind, parallel group, placebo-controlled trial, randomized 30 participants, 50 to 80 years old	Oral route	Four 250 mg tablets of dry powder of HE (96% of HE) or three placebo tablets per day for 16 weeks	Improved cognitive function scale scores	HDS-R Adverse effect evaluation Blood chemistry	N.A.
Saitsu et al., 2019 [62]	Normal cognitive functions Completed 12 weeks	Double-blind, placebo-controlled trial, parallel group, randomized 34 participants, 50 years old and above	Oral route	Four HE supplements containing 0.8 g of powdered fruiting body or four placebo supplements per day for 12 weeks	Significantly improved cognitive functions in MMSE	MMSE Benton visual retention test S-PA	N.A.

Abbreviations: MMSE, Mini-mental state examination; IADL, Instrumental activities of daily living; CASI, Cognitive abilities screening instrument; HE-A, erinacine A-enriched Hericium erinaceus mycelia; NPI, Neuropsychiatric inventory; HDS-R, Revised Hasegawa Dementia scale; S-PA, Standard verbal paired-associate learning test.