Visit: www.bacomind.

in

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A natural remedy for enhancing cognition

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What is Memory loss?

Memory: is the ability of the brain to store, retain and subsequently recall information. In the recent decades, it has become one of the principal pillars of a new branch of science, cognitive neuroscience. Cognitive processes are thus the mental processes involved in knowing about the world; as such, they are important in perception, attention, thinking, problem solving and memory
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Memory loss (amnesia) is unusual forgetfulness that can be caused by brain damage due to disease or injury, or it can be caused by severe emotional trauma. Aging causes deterioration of various aspects of memory performance in normal adults. Age Associated Memory Impairment (AAMI) is a common condition characterized by very mild symptoms of cognitive decline that occur as part of the normal aging process.
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Global incidence
 Information on the prevalence of AAMI is scanty. According to one

clinical study of Finland, prevalence rate of 56.8 % (men, 57.4%; women, 51.3%) was observed (Koivisto K et al., 1995). Research criteria proposed by the National Institute of Mental Health (NIMH) work group were applied.
The National Institute of Mental Health (NIMH) is part of the National Institutes of Health (NIH), a component of the U.S. Department of Health and Human Services. Koivisto K et al., Prevalence of age-associated memory impairment in a randomly selected population from eastern Finland. Neurology. 1995, 45:741-747.

Worldwide, there is a new case of dementia every seven seconds. More

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than 24.3 million people are currently estimated to have dementia, and 4.6 million new cases are diagnosed each year. Dementia is expected to double between 2001 and 2040 in developed nations; it is forecasted to increase by more than 300 percent in India and China.
Ferri et al., Global prevalence of dementia: a Delphi consensus study. The Lancet. 2005, 366: 2112-2117.

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Herbal approach to Memory loss

Bacopa monnieri (Linn.) Pennell. English name Bacopa Local name Family Part used
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Brahmi Scrophulariaceae Entire plant

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What is BacoMind ?
BacoMind (patent pending) is a clinically proven, standardized phytochemical composition derived from Bacopa monnieri, which is well known in Ayurveda as a Brain tonic. BacoMind has been developed after extensive research work of several years by Natural Remedies Pvt. Ltd. BacoMind is an ingredient with scientific backup of multiple in vitro, animal and clinical studies for dietary supplement and food / beverage industry. BacoMind aims to address
 Age Associated Memory Impairment (AAMI) in older people  Learning & Memory in children Requiring Individual Education Programme

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Clinical evidence of BacoMind

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Clinical Study in older persons

Efficacy and Tolerability of BacoMind on memory improvement in elderly participants - A randomized, double blind, placebo controlled study A randomized, double blind, placebo controlled study was conducted on 44 elderly individuals (21 placebo and 23 BacoMind; age group between 50-75 years)
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BacoMind (450 mg) or placebo was administered once daily up to 12 weeks, thereafter, medication was discontinued and subsequent 12 weeks was kept as withdrawal period. The study findings suggested that BacoMind improved the cognitive functions such as attention and verbal memory in elderly individuals and was also found to be well tolerated.
Harshad C Barbhaiya et al., Efficacy and tolerability of BacoMind on memory improvement in elderly participants - A double blind placebo controlled study. Journal of Pharmacology and Toxicology. 2008, 3(6): 425-434.

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Clinical Study in older persons

Study profile
65 elderly individuals (42 men and 23 women) Enrolled 6 SUBJECTS DROPPED OUT
3 - Were not present for the second visit 3 - Not present for complete study

59 (37 men and 22 women) Completed the study 15 subjects were outliered 44 (29 men and 15 women) participants were analysed for statistics

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BacoMind

23 (14 men & 09 women)

Placebo 21 (15 men & 06 women)

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Clinical Study in older persons

Neuropsychological tests
Attention tests
Digit span forward and backward (Wechsler Adult Intelligence Scale; WAIS) Digit cancellation test Serial substraction test

Memory Verbal
List learning (RAVLT) Immediate and delayed recall Passages (Weschler Memory Scale I; WMS I) Immediate and delayed recall
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Paired associates Similar and dissimilar pairs Immediate and delayed recall Visual retention I (based on designs) Visual retention II (based on pictures)

Speed of Information Processing

Digit Symbol (WAIS)
Reference: The memory tests were designed by Dept. of Psychiatry, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India, modified for geriatric population. The construction and standardization of these tests were based on Reys Auditory Verbal Learning Test (RAVLT) (Rey, A. 1964. Clinical Examination in Psychology. Paris, France: Presses Universitaires de France) and Weschler Memory Scale-I

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Clinical Study in older persons

Efficacy and Tolerability of BacoMind on memory improvement in elderly participants - A randomized, double blind placebo controlled study

Improvement in Attention
Digit span Backward
4.5 4 3.5 3 2.5 2 1.5 1 0.5 0 0th week 12th week
Placebo BacoMind

24th week

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(p=0.008)

 The result of analysis showed a significant interaction effect between group and time in digit span backward task  Between 0 and 12th week 4.88% improvement was observed in BacoMind treated group.

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Clinical Study in older persons

Efficacy and Tolerability of BacoMind on memory improvement in elderly participants - A randomized, double blind placebo controlled study

Improvement in Memory verbal

List learning Delayed Recall
4 3.5 3 2.5 2 1.5 1 0.5 0 0th week 12th week
Placebo BacoMind

24th week

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(p=0.014)

 A significant interaction effect between group and time was revealed in list learning delayed recall  Between 0 and 12th week 36.5 % and between 0 and 24th week 78.08 % improvement was observed in BacoMind treated group.

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Clinical Study in older persons

Efficacy and Tolerability of BacoMind on memory improvement in elderly participants - A randomized, double blind placebo controlled study

Improvement in Memory verbal

Paired associates Dissimilar Delayed Recall
4 3.5 3 2.5 2 1.5 1 0.5 0 0th week 12th week
Placebo BacoMind

24th week

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(p=0.047)

 A significant interaction effect between group and time was revealed in paired associates dissimilar delayed recall test  Between 0 and 12th week 14.64 % and between 0 and 24th week 36.40 % improvement was observed in BacoMind treated group.

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Clinical Study in older persons

Efficacy and Tolerability of BacoMind on memory improvement in elderly participants - A randomized, double blind placebo controlled study

Improvement in Visual memory

Visual Retention I
12 10 8 6 4 2 0 0th week 12th week
Placebo BacoMind

24th week

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(p=0.035)

 A significant interaction effect between group and time was revealed in visual retention -1 test  Between 0 and 12th week 21.94 % and between 0 and 24th week 11.3 % improvement was observed in BacoMind treated group.

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Clinical study in children

BacoMind: A Cognitive Enhancer in Children Requiring Individual Education Programme In the clinical trial consisting of 24 children (12 boys and 12 girls; age group between 4-18 years) BacoMind (225 mg, once daily) or placebo was administered for 4 months.

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BacoMind showed significant (p0.05) improvement in the working memory, logical memory, in memory related to personal life, visual and auditory memory in children requiring Individual Education Programme.
Usha PD et al., BacoMind: A cognitive enhancer in children requiring individual education programme. Journal of Pharmacology and Toxicology. 2008, 3(4): 302-310.

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Clinical study in children

Study profile
28 subjects (13 boys and 15 girls) Enrolled 4 SUBJECTS DROPPED OUT 24 (12 boys and 12 girls) Completed the study
2- didnt come for pre-assessment 2- didnt follow-up

24 (12 boys and 12 girls) were analysed for statistics

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Clinical study in children

Neuropsychological tests
Inclusion criteria adopted, Wechsler Intelligence Scale for Children (WISC) to assess the intelligence quotient of participants Memory Scale Test (The test comprises of 10 subtests)
Information: Assess the awareness of the child about self and the memory related to personal life Orientation: Assess the childs orientation to person, place and time Mental control: Checks childs working memory Digit span: Repeating digits forward: subtest checks immediate memory
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Repeating digits backward: subtest checks working memory Repeating the words: Checks the short term memory for verbal material Repeating the sentences: Gives idea about logical memory for verbal material Verbal retention of similar pairs: Gives idea about auditory memory for similar pairs Verbal retention of dissimilar pairs: Conveys about visual as well as auditory memory for dissimilar pairs of words Visual reproduction: Conveys about short term memory for non-verbal (graphic) material

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Recognition: Informs about short term memory for non-verbal material

Clinical study in children

% Improvement in memory test scores

* * * * * * *

* www.bacomind.in *p 0.05

Children requiring IEP (n=24) were categorized based on the % improvement in the total score of 10 memory subtests mentioned above Category I (n=4; % children 16.67) No change in the % improvement Category II (n=13; % children 54.17) Upto 20 % increase in improvement Category III (n=5; % children 20.83) 21-50 % increase in improvement Category IV (n=2; % children 8.33) 51-75 % increase in improvement NRPL

Clinical Study in older Australians

Efficacy of BacoMind in improving memory in healthy Australians over the age of 55 years - A 12 week randomized, double blind, placebo-controlled, parallel group clinical trial Study was conducted on 81 (45 placebo and 36 BacoMind) healthy older Australians (42 men and 39 women) over the age of 55 years, with an average age of 65.4 years (range 55-86)

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A clinical trial was carried out to assess the effects of 12-weeks administration of BacoMind (300 mg/day) on memory performance

The results demonstrated that BacoMind significantly improved memory acquisition and retention in older Australians.
Morgan, AK, THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE, Volume 16, Number 7, 2010, pp. 753759

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Clinical Study in older Australians

Assessed for eligibility (n=136)

Study profile
Randomized (n=103)

Excluded (n=33) -selection criteria not met (n=30) -declined consent (n=1) -other reasons (n=2)

Allocated to receive BacoMind (n=51) Received intervention (n=49) Did not receive intervention: -work commitments (n=1) -death in family (n=1)

Allocated to receive Placebo (n=52) Received intervention (n=49) Did not receive intervention: -work commitments (n=1) -travel (n=1) -lost to follow up (n=1)

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Followed up at 12-week visit (n=36)

Followed up at 12-week visit (n=45)

Withdrawn after baseline (n=13): -side effects (n=9) -lost to follow up (n=2) -concurrent illness (n=1) -accident (n=1)

Withdrawn after baseline (n=4): -side effects (n=2) -elective surgery (n=1) -concurrent illness (n=1)

Analysed (n=36)

Analysed (n=45)

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Clinical Study in older Australians

Screening methods
The initial screening included assessment of cognitive function and emotional state utilizing Mini-Mental State Examination (MMSE) (Folstein et al., 1975) & Hamilton Depression Scale (HAM-D) (Hedlung and Vieweg, 1979). Modified Hachinski Ischaemic scale (HIS) (Hachinski et al., 1975) was used to screen for cognitive deficits related to ischaemia and stroke Following instruments were used to give both objective and subjective measurements of memory at baseline and end of trial clinical sessions. Rey Auditory Verbal Learning Test (AVLT) (Rey, 1964) Rey-Osterrieth Complex Figure Test (CFT) (Rey, 1941) Trail Making Test (TMT) (Reitan, 1958)
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Memory Complaint Questionnaire (MAC-Q) (Crook et al., 1992)

References: Folstein MF, Folstein SE and McHugh PR. Mini Mental State: a practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research. 1975, 12: 189198. Hedlung JL and Vieweg MS. The Hamilton rating scale for depression. Journal of Operational Psychiatry. 1979, 10(2): 149-165. Hachinski V et al., Cerebral blood flow in dementia. Archives of Neurology. 1975, 32: 632-637. Rey A. L'examen psychologique dans les cas d'encephalopathie traumatique. Archives de Psychologie. 1941, 28: 286-340. Rey A. L'examen clinique in psychologie. Paris: Press Universitaire de France. 1964. Reitan RM. Validity of the Trail Making Test as an indicator of organic brain damage. Perceptual and Motor Skills. 1958, 8: 271-276. Crook TH, Feher EP and Larrabee GJ. Assessment of memory complaints in age-associated memory impairment: the MAC-Q. International Journal of Psychogeriatrics. 1992, 4: 165-176.

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Clinical Study in older Australians From the raw scores obtained on the AVLT a number of measures of memory function were obtained as follows (Lezak et al., 2004):
AVLT trial a1-a5: immediate recall

AVLT trial a6: recall post intrusion AVLT trial a7: delayed recall (assesses long term retention) AVLT trials a1-a5, summed scores: total learning AVLT trial a5 minus trial a6: retroactive interference AVLT trial a1 minus trial b: proactive interference AVLT recognition hit rate (correctly identified list A words) AVLT recognition false positives (words incorrectly identified as list A words) AVLT true recognition rate (recognition hit rate minus false positives) AVLT trial a6 minus trial a7: forgetting rate

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Lezak MD, Howieson DB and Loring DW. Neuropsychological Assessment 4th ed. New York: Oxford University Press. 2004.

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Clinical Study in older Australians

Results
 BacoMind significantly improved (p<0.05) memory function (verbal learning as well as delayed recall) as measured by performance AVLT tasks: trial a4, trial a5, trial a6, trial a7, total learning (trials a1-a5), and retroactive interference index.  % improvement in BacoMind group (pre vs. post test) AVLT a4 : 16% AVLT a5 : 7.06% AVLT a6 : 23.80% AVLT a7 : 20.65% AVLT total learning (a1-a5) : 7% AVLT retroactive interference : 49%  Improved performance was also noted on the CFT, MAC-Q and TMT. However, there were no significant differences between placebo and BacoMind. Following slides illustrate the treatment effects of BacoMind compared to placebo for each of the above significant outcome measures.
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Clinical Study in older Australians

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Clinical Study in older Australians

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Clinical Study in older Australians

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Pre-clinical evidence of BacoMind

(in vitro)
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In vitro studies

Serotonin 6 (5-HT6) receptor binding assay

5-HT6 is localized almost exclusively in the brain such as the cerebral cortex and hippocampus. Antagonists of serotonin 6 (5HT6) receptors have been reported to enhance cognition in animal models of learning.
Mark D. Lindner et al., An Assessment of the Effects of Serotonin 6 (5-HT6) Receptor Antogonists in Rodent Models of Learning. The Journal of Pharmacology and Experimental Therapeutics. 2003, 307(2): 682-691.

BacoMind has appreciable affinity to 5-HT6 receptors (radio ligand used - 3HLysergic acid diethylamide)
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SN

Substance ID

Concentration tested (Qg/ml) 500

% displacement (Average of two replicates) 92.16 90.26 88.15 80.02 62.64 55.32

BacoMind

100 50 500

2 NRPL

Bacoside A

100 50

In-house report no. NRPL/RBA/05-1

Since activity was detected, it was further tested at lower concentrations

SN Substance ID

Concentration tested (Qg/ml)

% Displacement (Average of two replicates) 40.33 21.6 9.29

10
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BacoMind

5 0.5

In-house report no. NRPL/RBA/05-2

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5-HT6 binding assay

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Further analysis to determine the nature of affinity is in progress

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Butyrylcholinesterase inhibition assay

Butyrylcholinesterase (BuChE) is an enzyme that is related to AChE. It is expressed in glia, endothelial cells, and in neurons in selected areas of the central and peripheral nervous systems. It is capable of catalyzing the hydrolysis of acetylcholine, and inhibition of BuChE leads to increased levels of acetylcholine in the brain.
Nigel HG et al., Selective butyrylcholinesterase inhibition elevates brain acetylcholine, augments learning and lowers Alzheimer -amyloid peptide in rodent. Proceedings of the National Academy of Sciences of the United States of America. 2005, November 22; 102(47): 1721317218.

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BacoMind showed butyrylcholinesterase inhibition activity with IC50 value < 3000 mcg/ml.

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Lipoxygenase inhibition assay

Lipoxygenases are a family of iron-containing enzymes that catalyse the dioxygenation of polyunsaturated fatty acids in lipids containing a cis-1,4-pentadiene structure. Arachidonate 5lipoxygenase enzyme, which transforms essential fatty acids (EFAs) into leukotrienes. The inhibition of lipoxygenase may play an important role in the inflammation and inflammation related disorders. Inflammatory processes are known to play a role in the decline of cognitive (thinking, learning and memory) function.

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BacoMind showed lipoxygenase inhibition activity with IC50 value < 600 mcg/ml.

In-house: Report No. NR/LIA/08/08

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Antioxidant assays
Antioxidants contribute to long-term structural and functional integrity of the brain by countering oxidative damage in neural tissues. Numerous clinical trials confirm the importance of antioxidant in preserving cognitive ability.
Marie-Laure Ancelin et al., Is Antioxidant Therapy a viable alternative for Mild Cognitive Impairment? Examination of the Evidence. Dementia and Geriatric Cognitive Disorders. 2007, 27: 1-19.

ABTS [2,2-azinobis-(3-ethylbenzothiazoline-6-sulfonic acid)] radical scavenging assay:

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BacoMind showed ABTS radical scavenging activity with IC50 value < 100 mcg/ml.
In-house: Report No. NR/ABTS/08/06

DPPH (2,2-diphenyl-1-picrylhydrazyl) assay: BacoMind showed DPPH radical scavenging activity with IC50 value < 200 mcg/ml.
In-house: Report No. NR/DPPH/08/14A

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Catechol-O-methyltransferase inhibition assay

Catechol-O-methyltransferase (COMT) is one of several enzymes plays a central role in the metabolic inactivation of catecholic neurotransmitter, such as dopamine, norepinephrine and epinephrine. COMT catalysis the transfer of methyl group from Sadenosyl-L-methionine to a catechol substrate, either endogenous or exogenous, in the presence of magnesium. COMT inactivates the catecholamines by O-methylation.
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The inhibition of COMT may play an important role in the memory related disorders. Memory related disorders to play a role in the decline of cognitive (thinking, learning and memory) function.

BacoMind showed catechol-o-methyltransferase inhibition activity with IC50 value = 16.66 mcg/ml.
In-house: Report No. ADME/COMT/IN/09/14-A

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Prolyl endopeptidase inhibition assay

Prolyl endopeptidase (PEP) is a serine proteinase that specifically cleaves peptidyl proline bonds. The enzyme is responsible for hydrolyse many biologically active peptides, including substance P, Neurotensin, Angiotensin II, Oxytocin and Bradykinin. These neuropeptides neurotensin and substance-p play a key role in positive reinforcement, social interactions, emotions and stress responsivity. Commonly increses PEP activity in the memory related disorders like Alzheimers, schizophrenia, mania and depression. BacoMindTM is a inhibior of PEP are believed to have anti-amnesic effects.

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BacoMind showed catechol-o-methyltransferase inhibition activity with IC50 value = 30 mcg/ml.

In-house: Report No. ADME/PEP/IN/09/26-A

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www.bacomind.in

Pre-Clinical evidence of BacoMind (in vivo)

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Nootropic activity of BacoMind using passive shock avoidance test in mice

Animals Test material Dose & duration Results Albino Swiss mice (20-22 g) of either sex BacoMind 40, 60 and 80 mg/kg for 7 days, p.o. BacoMind improved memory retention and showed significant (p < 0.001) decrease in latency to reach Shock free zone [SFZ] and number of mistakes in 15 min as compared to the vehicle control. BacoMind (60 mg/kg) when administered for 7 days not only facilitated the retention but also alleviated the scopolamine induced impairment of retention by significantly (p < 0.001) decreasing the latency to reach SFZ and number of mistakes in 15 min as compared to the scopolamine treated group.

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Kasture SB et al., Nootropic activity of BacoMindTM, an enriched phytochemical composition from Bacopa monnieri. Journal of Natural Remedies. 2007, 7(1): 166-173.

Nootropic activity of BacoMind using object recognition test in rats

Animals Test material Dose & duration Results Albino Wistar rats (150-175 g) of either sex BacoMind 27, 40 and 54 mg/kg, 7 days, p.o. BacoMind showed a significant (p < 0.001) increase in the discrimination index as compared to the vehicle control. BacoMind (40 mg/kg) administered for 7 days improved memory by preventing scopolamine induced amnesia and significantly (p < 0.001) increased the discrimination index as compared to the scopolamine treated group.

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Kasture SB et al., Nootropic activity of BacoMindTM, an enriched phytochemical composition from Bacopa monnieri. Journal of Natural Remedies. 2007, 7(1): 166-173.

Nootropic activity of BacoMind using elevated plus maze test in mice

Animals Test material Dose & duration Results Albino Swiss mice (20-22 g) of either sex BacoMind 40, 60 and 80 mg/kg, 7 days, p.o. A significant (p < 0.001) decrease in the inflexion ratio was noticed in the scopolamine treated group as compared to the vehicle control. BacoMind (60 mg/kg) administered orally for 7 days protected the animals from scopolamine induced impairment in learning and memory and significantly (p < 0.01) increase the inflexion ratio as compared to the scopolamine treated group.

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Kasture SB et al., Nootropic activity of BacoMindTM, an enriched phytochemical composition from Bacopa monnieri. Journal of Natural Remedies. 2007, 7(1): 166-173.

Safety studies on BacoMind

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Clinical Safety Studies

Safety evaluation of BacoMind in healthy volunteers: A phase I study

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Phase I clinical trial of BacoMind in 23 healthy adult volunteers (19 men and 4 women; aged between 22 to 42 years) revealed that at the given oral dose of 300 mg once a day for first 15 days and 450 mg for next 15 days, was safe and well tolerable. Though minor gastrointestinal side effects were reported in 3 out of 23 volunteers, the general physical, systemic, hematological, biochemical and electrocardiographic parameters were within the normal limits.
Pravina K et al., Safety evaluation of BacoMindTM in healthy volunteers: A phase I study. Phytomedicine. 2007, 14: 301-308.

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Clinical Safety Studies

Phase I clinical trial of BacoMind in elderly volunteers Phase I clinical trial of BacoMind in 15 elderly volunteers (11 men and 4 women; aged between 45 to 66 years) revealed that at the given oral dose of 300 mg once a day for first 14 days and 450 mg for further 14 days, was safe and tolerable. The physical, hematological and biochemical parameters were within the normal limits. Phase II clinical trials of BacoMind
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No clinically significant side effects were observed in phase II clinical studies on BacoMind in elderly and children requiring Individual Education Programme (IEP).
Harshad C Barbhaiya et al., Efficacy and tolerability of BacoMind on memory improvement in elderly participants - A double blind placebo controlled study. Journal of Pharmacology and Toxicology. 2008, 3(6): 425-434.

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Usha PD et al., BacoMind: A cognitive enhancer in children requiring individual education programme. Journal of Pharmacology and Toxicology. 2008, 3(4): 302-310.

Pre-Clinical Safety Studies

Salmonella reverse mutation assay OECD, 471
Salmonella reverse mutation assay was conducted to test the mutagenic potential of BacoMind using S. typhimurium tester strains viz. TA97a, TA98, TA100, TA102 and TA1535. BacoMind was tested at the concentrations of 61.72, 185.18, 555.55, 1666.67 and 5000 g/plate in the presence and absence of metabolic activation (S9 fraction). The study demonstrated that BacoMind did not show mutagenic effect in tested Salmonella strains.

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Dipanwita Dutta Deb et al., In vitro safety evaluation and anticlastogenic effect of BacoMindTM on human lymphocytes. Biomedical and Environmental Sciences. 2008, 21: 7- 23.

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Pre-Clinical Safety Studies

In vitro safety evaluation and anticlastogenic effect of BacoMind on Human Lymphocytes
Clastogenicity assays (chromosomal aberration and micronucleus test with and without metabolic activation ) were performed at the concentrations viz., 31.2, 62.5, and 125 g/ml of BacoMind. The number of chromosomal aberrations and the frequency of micronuclei induced by BacoMind were not statistically significant. BacoMind also demonstrated dose-dependent protection against the clastogens (Mitomycin C, Hydrogen peroxide and benzo [a] pyrene) induced clastogenicity in human lymphocytes . The above study suggested that BacoMind is non-clastogenic and also demonstrated anti-clastogenicity potential.
Dipanwita Dutta Deb et al., In vitro safety evaluation and anticlastogenic effect of BacoMindTM on human lymphocytes. Biomedical and Environmental Sciences. 2008, 21: 7- 23.

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Pre-Clinical Safety Studies

Acute oral toxicity study
The LD50 of BacoMind after oral administration as a single dose to Sprague-Dawley rats was found to be 2400 mg/kg b.w.

14-Day repeated dose toxicity study

In this study BacoMind was found to be tolerated well up to the dose of 500 mg/kg.

90-Day repeated dose toxicity study

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BacoMind at dose levels of 85, 210 and 500 mg/kg b.w. was administered orally for 90 consecutive days to Sprague Dawley rats. Administration of BacoMind did not reveal any evidence of toxicity with respect to clinical signs, neurological examination, food consumption, body weight gain, haematological and blood biochemistry parameters. The no observable adverse effect level (NOAEL) was found to be 500 mg/kg b.w.
Joshua Allan J et al., Safety evaluation of a standardized phytochemical composition extracted from Bacopa monnieri in Sprague-Dawley rats. Food and Chemical Toxicology. 2007, 45: 1928-37.

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Publications on BacoMind
K et al., Safety evaluation of BacoMindTM in healthy volunteers: A phase I study. Phytomedicine. 2007, 14: 301-308. Kasture SB et al., Nootropic activity of BacoMindTM, an enriched phytochemical composition from Bacopa monnieri. Journal of Natural Remedies. 2007, 7(1): 166-173. Joshua Allan J et al., Safety evaluation of a standardized phytochemical composition extracted from Bacopa monnieri in Sprague-Dawley rats. Food and Chemical Toxicology. 2007, 45: 1928-37. Dipanwita Dutta Deb et al., In vitro safety evaluation and anticlastogenic effect of BacoMindTM on human lymphocytes. Biomedical and Environmental Sciences. 2008, 21: 7- 23. Deepak M et al., Quantitative determination of the major saponins mixture bacoside A in Bacopa monnieri by HPLC. Phytochemical Analysis. 2005, 16: 24-29. Deepak M and Amit A. The need for establishing identities of bacoside A and B, the putative major bioactive saponins of Indian medicinal plant Bacopa monnieri. Phytomedicine. 2004, 11: 264-268. Usha PD et al., BacoMind: A cognitive enhancer in children requiring individual education programme. Journal of Pharmacology and Toxicology. 2008, 3(4): 302-310. Harshad C Barbhaiya et al., Efficacy and tolerability of BacoMind on memory improvement in elderly participants - A double blind placebo controlled study. Journal of Pharmacology and Toxicology. 2008, 3(6): 425-434. Morgan C et al., Does Bacopa monnieri improve memory performance in older persons? Results of a randomized, placebo controlled, double blind trial. The Journal of Alternative Complementary Medicine. 2010, 16(7): 753-759.

Pravina

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Presentations on BacoMind
Proceedings of the International Conference on Toxicology, Toxicogenomics and Occupational Health (ICTTOH) & 26 Annual Meeting of Society of Toxicology (STOX), 2006, Gwalior. Joshua Allan J et al., Safety evaluation of BacoMindTM: A standardized extract of Bacopa monnieri in Sprague Dawley rats. O61: 56-57. Joshua Allan J et al., Toxicity studies on BacoMindTM: A standardized phytochemical composition from Bacopa monnieri. P19: 97. Proceedings of the International Conference on Advances in Drug Discovery Research 11 ISCBC 2007, Lucknow. Barbhaiya HC et al., A double blind placebo controlled study of BacoMindTM on cognition enhancement in elderly volunteers. OL20: 61-62. Kasture SB et al., Effect of BacoMindTM, an enriched phytochemical composition from Bacopa monnieri, on learning and memory in rats and mice. PP158: 184-185. Pravina K et al., Evaluation of safety and tolerability of BacoMindTM in healthy volunteers. PP159: 185-186.
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International Conference on Biomarkers in Health and Environmental Management, 2007, Coimbatore. Dipanwita Dutta Deb et al., Antigenotoxic and anticlastogenic effect of BacoMindTM on human lymphocytes. PP: 73 Proceedings of the Annual Conference of Southern Regional Indian Pharmacological Society (SRIPS), 2008, Pondicherry. Usha PD et al., Nootropic effect of BacoMind in children requiring individual education programme. PP34: 82. Proceedings of International Conference on New Developments in Drug Discovery from Natural Products and Traditional Medicines, NIPER-2008, Punjab. Amit Agarwal. BacoMind: A natural remedy for enhancing cognition. IL25: 129.

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Phytochemistry of BacoMind

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BacoMind is enriched phytochemical composition with true claims on the optimum levels of nine bioactive constituents
HO H3C CH3 CH3 CH3 O CH3

H H3C CH3 H H

CH3

CH3

CH3
O H3C OH OH O O O OH HO OH O OH HO OH OH O CH3

H H H

H3C

OH O O

Bacoside A3

OH HO OH

-sitosterol-D-glucoside

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CH3 HO CH3 H3C

HO H3C

CH3

CH3 CH3 CH3 O

CH3

CH3

O
O

O
O OH OH O O OH HO OH O OH HO O OH H3C CH3

H3C

CH3

OH HO O O OH HO
O

O OH O OH HO

Bacopaside II
OH

OH

Jujubogenin isomer of bacopasaponin C

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OH

Bacosine
HO O

OH

Luteolin
OH O
OH

HO

Apigenin
OH O
CH3
CH3

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Bacopaside I
CH3 CH3

HO H3C CH3

HO CH3

Bacopasaponin C
CH3 O H3C CH3

H3C

CH3

O
O

O O HO S O O O OH HO OH HO O OH
HO OH HO OH O OH O

HO O

O O H3C
OH

CH3
O

OH O

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HO

OH

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Standardization of BacoMind
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HPLC Chromatogram

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Recommended dose of BacoMind For adult - 450 mg/day for 12 weeks. For children 225 mg/day for 16 weeks. Intended use of BacoMind
Supports brain performance, attention and memory. Assists in mental functioning Supports mental sharpness and working memory in elders Enhances mental alertness and learning performance in children
The above claims are structure/functional claims Reference: The Dietary Supplements Labels Database. United States National Library of Medicine
http://dietarysupplements.nlm.nih.gov/dietary/index.jsp

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These statements have not been evaluated by the Food and Drug Administration or any other regulatory body. This product is not intended to diagnose, treat, cure or prevent any disease.

Summary - BacoMind
BacoMind is an ingredient with clinical support. The benefits of BacoMind for memory and cognitive health (both in elderly and children) have been confirmed by clinical studies. BacoMind is proven to be safe and non-toxic in both animal and clinical trials at the recommended dosage. BacoMind is chemically standardized to 9 different bioactive compounds by HPLC and HPTLC. Each commercial batch of BacoMind is biologically tested using assays like Lipoxygenase inhibition, Butyrylcholinesterase inhibition, ABTS radical scavenging and DPPH radical scavenging. BacoMind is available as a free flowing powder A PCT patent has been filed on BacoMind to protect the intellectual property.  BacoMind is manufactured in a GMP, ISO 9001:2000 and ISO 22000:2005 certified manufacturing facility BacoMind is Kosher certified.

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BacoMind - Flyers
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De-bitterised BacoMind

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Product Promotion through media

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Progress so far .
NRPL Dr H N Shivaprasad

BacoMind
Independent study Published on the Memory enhancing effect of BacoMind 29-07-2010`

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Natural Remedies Launches BacoMind-DB 04-02-2010

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Thank you
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