Merck & Co., Inc. Release: New Data Demonstrated Cognigram&#0153 as a Useful Tool in Assessing Cognitive Function

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MONTREAL, July 17, 2013 /CNW/ - New data provided evidence of a useful new tool in the detection and monitoring of cognitive impairment in aging and dementia. The data showed the clinical utility of Cognigram to identify cognitive impairment in people with and at risk of Alzheimer's disease (AD).1 The data was presented at the Alzheimer's Association International Conference (AAIC), currently taking place in Boston, Massachusettsbetween July 13 and 18.

"As an innovative cognitive online evaluation tool, Cognigram was developed to broadly assess four critical cognitive domains psychomotor function, attention, learning and working memory through card playing tasks," said Dr. Paul Maruff, Chief Science Officer at Cogstate. "These study results are important as they demonstrate the sensitivity and specificity of Cognigram. This means that Cognigram can be used in clinical practice settings to identify even subtle impairments that can signify the earliest stage of dementia."

Cognitive Function in Aging
Cognition is the mental process of knowing, including aspects such as awareness, perception, reasoning, and judgment.2 Some decrease in cognition is expected at older ages, but the decline is not uniform across all cognitive tasks or for all individuals.Impaired cognition can have health consequences, such as first stroke, falls, and institutionalization.3 It may reduce an individual's ability to communicate pain to health care providers,carry out instrumental activities of daily living,cope with chronic disease symptoms, perform self-care and adhere to medication instructions.4

The number of Canadians living with cognitive impairment, including dementia, was 747,000 in 2012 and will double to 1.4 million by 2031.5 The annual economic burden is expected to increase substantially from approximately $15 billion in 2008 to $153 billion by the year 2038.6

"The burden of dementia is growing rapidly. As a physician, I witness first-hand the profound impact of Alzheimer's disease and related dementias on the everyday lives of patients and their families. The hardship is greater when cognitive changes are not identified early," says Dr. Sharon Cohen, Neurologist and Medical Director of Toronto Memory Program. "New computerized assessment tools are valuable in the accurate detection of early cognitive impairment and in monitoring cognitive change over time."

About the Study7
The study included 653 healthy older adults, 68 adults with mild cognitive impairment (MCI), and 44 adults with AD who completed the Cognigram system. Participants were recruited from the Australian Imaging, Biomarkers, and Lifestyle (AIBL) Study of Ageing, and the AIBL-Rate of Change sub-study (AIBL-ROCS). The four performance measures of Cognigram were reduced to two composites - psychomotor/attention and learning/working memory. Sensitivity and specificity analyses were conducted on the two composites to determine their clinical utility. The AIBL study in which participants were recruited from, aimed to discover which biomarkers, cognitive characteristics, and health and lifestyle factors determine subsequent development of symptomatic Alzheimer's disease.8 The AIBL study is supported by the Science and Industry Endowment Fund in Australia.9

About the Results10
Large impairments in MCI (d = 1.20) and AD (d = 2.20) were identified for the learning/working memory composite but not the psychomotor/attention composite (MCI d = 0.40; AD d = 0.50). Using a cutscore of -1.96, the learning/working memory composite showed 85.71 per cent sensitivity and 96.81 per cent specificity to a clinical classification of Alzheimer's disease. Both composite scores showed high test-retest reliability (0.95) over four months. Performance on the memory composite was also related to performance on the MMSE, with worse scores on the MMSE associated with worse performance on the Cognigram memory composite.

About Cognigram
Cognigram is a computer-based system designed to measure and monitor cognitive function for neuro-degenerative diseases such as mild cognitive impairment and Alzheimer's disease. Merck Canada Inc. promotes Cognigram in Canada. Cognigram was created and is supplied by Cogstate Ltd. The partnership is part of the ongoing commitment from Merck to improve disease management involving the central nervous system.

About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information about our operations in Canada, visit www.merck.ca.

Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2012 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

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1 Maruff, Paul et al. Clinical utility of the Cogstate brief battery in Alzheimer's disease related memory impairment. Poster presented at the Alzheimer's Association International Conference on Sunday, July 14, 2013.

2Gilmour, Heather. Cognitive performance of Canadian seniors. Statistics Canada. June 2011. Available at: http://www.statcan.gc.ca/pub/82-003-x/2011002/article/11473-eng.pdf.

3 Ibid.

4 Ibid.

5 Alzheimer Society of Canada. A new way of looking at the impact of dementia in Canada. Available at: http://www.alzheimer.ca/~/media/Files/national/Media-releases/asc_factsheet_new_data_09272012_en.ashx.

6 The Alzheimer Society. Rising Tide: The Impact of Dementia on Canadian Society. Executive Summary. 2010. Available at: http://www.alzheimer.ca/on/~/media/Files/national/Advocacy/ASC_Rising%20Tide-Executive%20Summary_Eng.ashx.

7 Maruff, Paul et al. Clinical utility of the Cogstate brief battery in Alzheimer's disease related memory impairment. Abstract. 2013.

8 Introducing the AIBL. The Australian Imaging, Biomarker & Lifestyle Flagship Study of Ageing (AIBL). May 14, 2013. Available at: http://www.aibl.csiro.au/.

9 Ibid.

10 Maruff, Paul et al. Clinical utility of the Cogstate brief battery in Alzheimer's disease related memory impairment. Abstract. 2013.

SOURCE Merck



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