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A cognition enhancer

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A natural remedy for enhancing cognitionNRPL

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 memorywww.bacomind.in

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.NRPL

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. Morewww.bacomind.in

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 lossBacopa monnieri (Linn.) Pennell. English name Bacopa Local name Family Part usedwww.bacomind.in

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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www.bacomind.in

Clinical evidence of BacoMind

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Clinical Study in older personsEfficacy 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)www.bacomind.in

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 profile65 elderly individuals (42 men and 23 women) Enrolled 6 SUBJECTS DROPPED OUT3 - 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 testsAttention testsDigit span forward and backward (Wechsler Adult Intelligence Scale; WAIS) Digit cancellation test Serial substraction test

Memory VerbalList learning (RAVLT) Immediate and delayed recall Passages (Weschler Memory Scale I; WMS I) Immediate and delayed recallwww.bacomind.in

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

Improvement in AttentionDigit span Backward4.5 4 3.5 3 2.5 2 1.5 1 0.5 0 0th week 12th weekPlacebo 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 personsEfficacy and Tolerability of BacoMind on memory improvement in elderly participants - A randomized, double blind placebo controlled study

Improvement in Memory verbalList learning Delayed Recall4 3.5 3 2.5 2 1.5 1 0.5 0 0th week 12th weekPlacebo 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 personsEfficacy and Tolerability of BacoMind on memory improvement in elderly participants - A randomized, double blind placebo controlled study

Improvement in Memory verbalPaired associates Dissimilar Delayed Recall4 3.5 3 2.5 2 1.5 1 0.5 0 0th week 12th weekPlacebo 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 personsEfficacy and Tolerability of BacoMind on memory improvement in elderly participants - A randomized, double blind placebo controlled study

Improvement in Visual memoryVisual Retention I12 10 8 6 4 2 0 0th week 12th weekPlacebo 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 childrenBacoMind: 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 profile28 subjects (13 boys and 15 girls) Enrolled 4 SUBJECTS DROPPED OUT 24 (12 boys and 12 girls) Completed the study2- didnt come for pre-assessment 2- didnt follow-up

24 (12 boys and 12 girls) were analysed for statisticswww.bacomind.in

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Clinical study in children

Neuropsychological testsInclusion 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 memorywww.bacomind.in

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 AustraliansEfficacy 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 AustraliansAssessed for eligibility (n=136)

Study profileRandomized (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 methodsThe 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)www.bacomind.in

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