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Clinical Studies/Cases of Amyloban 3399
Antidementia
Prior to the introduction of Amyloban 3399 in 2008, a double-blind, placebo-controlled study on patients with mild cognitive impairment (due to dementia) was conducted with a tablet form containing 96% of dry powder of lion's mane.20 Thirty elderly men and women (50–80 years old) were randomized into two groups (n = 15): the experimental group (treated with tablets) and the placebo group (no treatment). During a 16-week study period, the experimental group showed significantly increased scores of a cognitive function scale compared with the placebo group even at 8 weeks (12 and 16 weeks as well). However, at 4 weeks (no tablet intake) following the end of the 16-week trial, even the improved scores of the experimental group significantly decreased.20 Thus, lion's mane does have the bioactivity to improve cognitive function in those patients; however, its continuous intake seems to be required for sustaining its efficacy.
Following this inspiring study, some clinical trials or individual case studies were conducted to address whether Amyloban 3399 could prevent a decline in cognitive function in dementia or would be possible to treat such dementia. In a relatively large-scale study, patients with the different stages of dementia (primarily the AD type) were placed on an Amyloban 3399 regimen.9 Daily dosage of Amyloban 3399 varied with the conditions of individual patients. Within a year, an Amyloban 3399 regimen resulted in marked improvements of cognitive function in those with a year of onset of dementia or mild cognitive impairment. Even those with diminished cognitive functions resulting from taking a hypnotic, anxiolytic, or antidepressant showed apparent restoration of cognitive function. Hence, Amyloban 3399 can raise the level of consciousness in patients with dementia, perhaps reviving the normal brain actions/functions. It is encouraging that mild cognitive impairment (due to dementia) could be significantly prevented and improved with Amyloban 3399.
On the other hand, the cognition-enhancing activity of Amyloban 3399 on healthy subjects has also been assessed.21 A 2-month clinical trial was conducted by measuring memory improvement and mood in 8 healthy participants (aged 52–78). Some participants felt "more upbeat and energetic" or "more focused, composed, and disciplined." Overall, Amyloban 3399 has improved memory, mood, and sense of well-being in all participants who were free of any medications.21 In other words, Amyloban 3399 may help enhance cognition and alertness in normal people. Moreover, Amyloban 3399 was generally well tolerated with no adverse effects observed in any participants during a trial. Therefore, these findings suggest that Amyloban 3399 is safe to be taken regularly to possibly prevent or reduce the risk for developing dementia, including AD.
Improvements of Schizophrenia
Apart from the beneficial effects of Amyloban 3399 against neurodegenerative diseases, it has also been shown to have positive effects on other neurological or mental disorders/diseases.
Schizophrenia is a mental disorder primarily characterized by cognitive dysfunction: those with impaired cognition cannot tell what is real from what is imagined and would have a poor social and occupational functioning.22 In the study, 10 patients with schizophrenia were treated with Amyloban 3399 to assess possible improvements in cognitive symptoms.23 Although all patients were refractory to current antipsychotic agents, they all showed the improved symptoms with Amyloban 3399, evidenced by the improved average scores of the positive and negative syndrome scale (PANSS). Thus, this study indicates that Amyloban 3399 could be beneficial for treating schizophrenic patients with cognitive impairments.
Hypersomnia and Sleep Apnea
Since Amyloban 3399 can increase alertness, its possible effect on people with hypersomnia was studied. Hypersomnia, or excessive sleep, could be attributed to a structural disorder of the brain; in fact, sleeping in the daytime is often seen in patients with dementia. In the study, Amyloban 3399 was found to raise the level of alertness, resulting in the increased hours in staying awake (or the decreased sleeping time).9 Thus, Amyloban 3399 may simply help bring sleep times back to normal.
In addition, the effects of Amyloban 3399 were examined on sleep-related breathing disorders such as apnea, a condition in which breathing becomes very shallow or may even completely stop during sleep. Nine patients received Amyloban 3399 for 2 months and tested for sleep apnea-hypopnea and snoring. The study showed the gradual improvements in apnea-hypopnea index as well as snoring index in these patients.9 Therefore, this finding suggests that Amyloban 3399 appears to improve sleep apnea and control snoring.
Depression and Anxiety
Depression and anxiety could be considered mental illness because they can lead to emotional and physical problems. In one clinical case, an 86-year-old male patient with recurrent depressive disorder was placed on an Amyloban 3399 regimen. After 6 months, his mild cognitive impairment (due to depression) was significantly improved and his body weight was also restored.24 Moreover, it is worthwhile mentioning another clinical study of 30 female patients with depression and/or anxiety, although it was conducted using the powdered lion's mane instead of Amyloban 3399.25 Patients were randomized into an experimental group (treated with lion's mane) or placebo group (no treatment). After 4 weeks, all test scores indicated the reduced levels of depression and anxiety in the experimental group compared with the placebo group.25 The same outcomes are yet anticipated with Amyloban 3399. Thus, these results imply that Amyloban 3399, a product of lion's mane, could be useful in people who suffer from depression and anxiety.
Conclusions
Amyloban 3399 is a natural, potent bioactive product made from Amycenone (a standardized lion's mane extract), consisting of hericenones (0.5%) and amyloban (6%). A sufficient number of studies indicate that Amyloban 3399 has beneficial effects on neurodegenerative diseases, capable of inducing NGF synthesis, diminishing Ab neurotoxicity, and protecting neuronal cell death from oxidative or ER stress. Thus, Amyloban 3399 could be used for the prevention and/or treatment of neurodegenerative diseases/disorders (dementia and AD). In addition, it may also have the beneficial effects on neurological or mental disorders/disease such as schizophrenia, depression, anxiety, hypersomnia, sleep apnea and other unidentified entities.
Moreover, lion's mane, the original source of Amyloban 3399, appears to have other significant bioactivities, including antitumor, antiviral, antimicrobial, immune-enhancing, antioxidant, hemagglutinating, hypolipidemic, and hypoglycemic activities.8,25 It is thus tempting to further explore other hidden potentials of Amyloban 3399 besides its neurological effects, and such studies are currently under way.
Notes
1. Morris MC, Tangney CC. Dietary fat composition and dementia risk. Neurobiol Aging. 2014;35:S59–S63.
2. Bennett DA, Evans DA. Alzheimer's disease. Dis Mon. 1992;38:1–64.
3. Assistant Secretary for Planning and Evaluation. National plan to address Alzheimer's disease: 2013 Update. US Department of Health and Human Services.
4. Bendlin BB, Carlsson CM, Gleason CE, et al. Midlife predictors of Alzheimer's disease. Maturitas. 2010;65:131–137.
5. Kawagishi H, Ando M, Mizuno T. Hericenone A and B as cytotoxic principles from the mushroom Hericium erinaceum. Tetrahedron Lett. 1990;31:373–376.
6. Kawagishi H, Ando M, Sakamoto H, et al. Hericenones C, D, and E, stimulators of nerve growth factor (NGF)-synthesis, from the mushroom Hericium erinaceum. Tetrahedron Lett. 1991;32:4561–4564.
7. Kawagishi H, Ando M, Shinba K, et al. Chromans, Hericenones F, G, and H from the mushroom Hericium erinaceum. Phytochemistry. 1993;32:175–178.
8. Kawagishi H, Zhuang C. Compounds for dementia from Hericium erinaceum. Drugs Future. 2008;33:149–155.
9. Inanaga K. Amycenone, a nootropic found in Hericium erinaceum. Personal Med Universe. 2012;1:13–17.
10. Nagai K, Chiba A, Nishino T, Kubota T, Kawagishi H. Dilinoleoyl-phosphatidylethanolamine from Hericium erinaceum protects against ER stress-dependent Neuro2a cell death via protein kinase C pathway. J Nutr Biochem. 2006;17:525–530.
11. Ueda K, Tsujimori M, Kodani S, et al. An endoplasmic reticulum (ER) stress-suppressive compound and its analogues from the mushroom Hericium erinaceum. Bioorg Med Chem. 2008;16:9467–9470.
12. Eriksdotter Jonhagen M, Nordberg A, Amberla K, et al. Intracerebroventricular infusion of nerve growth factor in three patients with Alzheimer's disease. Dement Geriatr Cogn Disord. 1998;9:246–257.
13. Hardy J, Selkoe DJ. The amyloid hypothesis of Alzheimer's disease: progress and problems on the road to therapeutics. Science. 2002;297:353–356.
14. Nakagawa T, Zhu H, Morishima N, et al. Caspase-12 mediates endoplasmic-reticulum-specific apoptosis and cytotoxicity by amyloid-beta. Nature. 2000;403:98–103.
15. Hensley K, Carney JM, Mattson MP, et al. A model for b-amyloid aggregation and neurotoxicity based on free radical generation by the peptide: relevance to Alzheimer disease. Proc Natl Acad Sci USA. 1994;91:3270–3274.
16. Mori K, Obara Y, Moriya T, Inatomi S, Nakahata N. Effects of Hericium erinaceus on amyloid b(25-35) peptide-induced learning and memory deficits in mice. Biomed Res. 2011;32:67–72.
17. Pike CJ, Walencewicz-Wasserman AJ, Kosmoski J, Cribbs DH, Glabe CG, Cotman CW. Structure-activity analyses of beta-amyloid peptides: contributions of the beta 25-35 region to aggregation and neurotoxicity. J Neurochem. 1995;64:253–265.
18. Haynes CM, Titus EA, Cooper AA. Degradation of misfolded proteins prevents ER-derived oxidative stress and cell death. Mol Cell. 2004;15:767–776.
19. Burda K, Czubak A, Kus K, Nowakowska E, Ratajczak P, Zin J. Influence of aripiprazole on the antidepressant, anxiolytic and cognitive functions of rats. Pharmacol Rep. 2011;63:898–907.
20. Mori K, Inatomi S, Ouchi K, Azumi Y, Tuchida T. Improving effects of the mushroom Yamabushitake (Hericium erinaceus) on mild cognitive impairment: a double-blind placebo-controlled clinical trial. Phytother Res. 2009;23:367–372.
21. Lottor ES. Amyloban 3399 product study for cognitive function improvement. Townsend Lett. 2009;May:94–95.
22. Millan MJ, Fone K, Steckler T, Horan WP. Negative symptoms of schizophrenia: clinical characteristics, pathophysiological substrates, experimental models and prospects for improved treatment. Eur Neuropsychopharmacol. 2014;24:645–692.
23. Inanaga K, Matsuki T, Hoaki Y, et al. Improvement of refractory schizophrenia on using Amyloban® 3399 extracted from Hericium erinaceum. Personal Med Universe. 2014;3:49–53.
24. Inanaga K. Marked improvement of neurocognitive impairment after treatment with compounds from Hericium erinaceum: a case study of recurrent depressive disorder. Personal Med Universe. 2014:3:46–48.
25. Nagano M, Shimizu K, Kondo R, et al. Reduction of depression and anxiety by 4 weeks Hericium erinaceus intake. Biomed Res. 2010;31:231–237.
Sensuke Konno, PhD
Department of Urology
New York Medical College
BSB Room A03
Valhalla, New York 10595, USA
914-594-3745
sensuke_konno@nymc.edu
 Dr. Konno received his Ph.D. in Biochemistry and Molecular Biology in 1991 and is currently serving as an Associate Professor and Director of Urology Research at the Department of Urology, New York Medical College (Valhalla, NY). His primary research focuses on establishing the more effective therapeutic modalities for three prevalent urological cancers such as prostate, bladder, and kidney cancers. Particularly, he has been exploring the alternative, unconventional modalities using natural agents/substances, such as bioactive extracts from mushroom, grape seed, watercress, broccoli etc. For potential adjuvant therapy, he has been also investigating combinations of these natural agents and chemotherapeutic drugs or interferons in order to improve the therapeutic efficacy. In addition, searching for possible prevention and/or treatment of kidney stone (nephrolithiasis) or renal ischemia/reperfusion injury, he has been working on certain antioxidants, which might exhibit the renoprotective effects against those renal disorders by diminishing oxidative stress. Because of his special interest in oxidative stress, recently he also started exploring possible beneficial effects of specific mushroom extracts with antioxidant activities on neurodegenerative diseases such as Alzheimer's disease. His work has been presented and well received at numerous domestic and international meetings/conferences and published in a number of the major journals. Moreover, Dr. Konno also serves as a peer-reviewer for several scientific/medical journals as well as a moderator at the meetings. He is a professional member of American Urological Association (AUA), American Association for Cancer Research (AACR), and American Association for the Advancement of Science (AAAS).
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