CBC Program This Evening

Cognition: Giving Wayfinding Directions

The British Psychological Society's (BPS) Research Digest blog has an interesting post about a study that concerns itself with giving route directions: link

Neuropsychology Abstract of the Day: Neurodegeneration in Alzheimer Disease

de Jong LW, van der Hiele K, Veer IM, Houwing JJ, Westendorp RG, Bollen EL, de Bruin PW, Middelkoop HA, van Buchem MA, & van der Grond J. Strongly reduced volumes of putamen and thalamus in Alzheimer's disease: An MRI study. Brain. 2008 Nov 20.

Department of Radiology, Section Neuropsychology of the Department of Neurology, Department of Medical Statistics, Department of Geriatrics and Department of Neurology of the Leiden University Medical Center, Leiden, The Netherlands.

Atrophy is regarded a sensitive marker of neurodegenerative pathology. In addition to confirming the well-known presence of decreased global grey matter and hippocampal volumes in Alzheimer's disease, this study investigated whether deep grey matter structure also suffer degeneration in Alzheimer's disease, and whether such degeneration is associated with cognitive deterioration. In this cross-sectional correlation study, two groups were compared on volumes of seven subcortical regions: 70 memory complainers (MCs) and 69 subjects diagnosed with probable Alzheimer's disease. Using 3T 3D T1 MR images, volumes of nucleus accumbens, amygdala, caudate nucleus, hippocampus, pallidum, putamen and thalamus were automatically calculated by the FMRIB's Integrated Registration and Segmentation Tool (FIRST)-algorithm FMRIB's Software Library (FSL). Subsequently, the volumes of the different regions were correlated with cognitive test results. In addition to finding the expected association between hippocampal atrophy and cognitive decline in Alzheimer's disease, volumes of putamen and thalamus were significantly reduced in patients diagnosed with probable Alzheimer's disease. We also found that the decrease in volume correlated linearly with impaired global cognitive performance. These findings strongly suggest that, beside neo-cortical atrophy, deep grey matter structures in Alzheimer's disease suffer atrophy as well and that degenerative processes in the putamen and thalamus, like the hippocampus, may contribute to cognitive decline in Alzheimer's disease.

PMID: 19022861 [PubMed - as supplied by publisher]

The GEM Study

From an NIH press release earlier today:

Ginkgo Evaluation of Memory (GEM) Study Fails To Show Benefit in Preventing Dementia in the Elderly

The dietary supplement Ginkgo biloba was found to be ineffective in reducing the development of dementia and Alzheimer's disease in older people, according to a study published in the Journal of the American Medical Association1. Researchers led by Stephen T. DeKosky, M.D., formerly of the University of Pittsburgh, vice president and dean of the School of Medicine at the University of Virginia in Charlottesville, conducted the trial known as the Ginkgo Evaluation of Memory (GEM) study at four clinical sites over the course of 8 years. GEM is the largest clinical trial ever to evaluate ginkgo's effect on the occurrence of dementia.

This research was co-funded by five components of the National Institutes of Health (NIH): National Center for Complementary and Alternative Medicine (NCCAM); National Institute on Aging (NIA); National Heart, Lung, and Blood Institute; National Institute of Neurological Disorders and Stroke, and the Office of Dietary Supplements.

"We have made enormous progress in understanding the basic mechanisms involved in Alzheimer's disease, and we continue to pursue a vigorous program to translate what we know into the development and testing of new potential therapies for this devastating disease," said Richard Hodes, M.D., director of the NIA. "However, it is disappointing that the dietary supplement tested in this study had no effect in preventing Alzheimer's disease."

GEM enrolled 3,069 participants age 75 or older with normal cognition or mild cognitive impairment. Those with dementia were excluded from participation. After extensive medical and neuropsychological screening, participants were randomly assigned to receive twice-daily doses of either 120 milligrams of ginkgo extract or an identical-appearing placebo. The 240 milligrams daily dose of ginkgo was selected based on current dosage recommendations and prior clinical studies indicating possible effectiveness at this dose. The products used in the study were supplied by Schwabe Pharmaceuticals, a German company.

"According to the 2007 National Health Interview Survey, ginkgo is one of the top 10 natural products used by Americans," said Richard L. Nahin, Ph.D., M.P.H., acting director of the Division of Extramural Research at NCCAM. "It is important to conduct studies and build the scientific evidence base regarding botanical supplements through rigorous research, such as the GEM trial."

The study was conducted primarily to determine if ginkgo would decrease the incidence of all types of dementia and, more specifically, reduce the incidence of Alzheimer's disease. Secondarily, the study evaluated ginkgo for its effects on overall cognitive decline, functional disability, incidence of cardiovascular disease and stroke, and total mortality. The primary endpoint was the diagnosis of dementia as determined by an expert panel of clinicians using standard criteria for diagnosis. The patients with a diagnosis of dementia underwent magnetic resonance imaging scans to determine their dementia type.

"The results of this study confirm the importance of randomized trials in the development of new therapies for dementia and Alzheimer's disease and in determining therapeutic benefit not only for conventional therapies but also complementary therapies like ginkgo," said Dr. DeKosky, principal investigator on the GEM study. "If older patients are considering using ginkgo for preventing dementia, I urge them to speak with their health care providers about the results of this study and work together to create the best treatment plan."

Study participants were followed for an average of approximately 6 years (maximum of just over 7 years). During the study, 523 participants were diagnosed with dementia, 246 in the placebo group and 277 in the ginkgo group. Thus, ginkgo showed no overall effect for reducing all types of dementia or Alzheimer's disease. In addition, in analyzing safety data, the GEM study did not find significant adverse effects from ginkgo, in particular there was no evidence for increased bleeding risk in persons taking ginkgo.

Cognitive status was known for more than 93 percent of all participants at the end of the trial and 60 percent of active participants were taking their assigned study medication. There was no difference in adherence to taking medication between the ginkgo group and the placebo group.

"While this study revealed that ginkgo does not have an effect on reducing dementia in the study populationit does provide us with important information about how to design and conduct large dementia prevention trials in older adults" said Dr. Jeff Williamson, a geriatrician and principal investigator of the GEM Clinical Coordinating Center at Wake Forest University. "Future analyses will provide us with additional information on ginkgo's possible effects on cardiovascular disease, cancer, depression and other age-related conditions. We are especially grateful to the more than 3,000 older adults who dedicated many hours to helping us answer the important questions addressed by GEMS."

The GEM results will prove useful in determining how many participants are needed in future trials to provide clinically significant measures on outcomes such as occurrence of dementia. Future analysis of this study may also identify subgroups of these participants who may be at greater risk for developing dementia.

Data analysis for the trial was overseen by the University of Washington, Seattle and the four GEM institutions that participated in this study were

University of Pittsburgh
Wake Forest University, Winston-Salem, N.C.
Johns Hopkins University, Baltimore, Md.
University of California, Davis

[ ... Read the full press release ... ]


The GEM website: link

Neuropsychology Abstract of the Day: Aging and Cognition

Pratt LA, Weeks JD, & Goulding MR. Measures of cognitive functioning in the 1994-2000 Second Longitudinal Study of Aging. National Health Statistics Reports. 2008 Jul 7; (2): 1-15.

US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics, Hyattsville, MD 20782, USA.

OBJECTIVES: This report describes in detail the measures of cognitive functioning administered in the Second Longitudinal Study of Aging (LSOA II) and proposes a three-category cognitive impairment variable for analysts' use that is derived from the individual measures. METHODS: LSOA II self-respondents completed an 11-question cognitive functioning measure based on the Telephone Interview of Cognitive Status (TICS) instrument. Proxy respondents answered nine questions drawn from the short Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Using cut points provided in the literature as a guide, a single three-level categorical measure of cognitive impairment was created: probable, possible, and no cognitive impairment. RESULTS: The cognitive functioning measures administered in LSOA II retain many of the favorable psychometric properties of the original TICS and IQCODE. The constructed cognitive impairment (CI) variable demonstrates good construct validity, and prevalence rates are generally consistent with those from other published studies. CONCLUSIONS: The categorical CI variable is easy to use and interpret and allows analysts the option of combining self- and proxy-respondent data in investigations of associations between CI and health outcomes, including continuing independence, progressive impairment, health care utilization patterns, and mortality.

PMID: 18839800 [PubMed - indexed for MEDLINE]

Obama!

Upcoming Event: 15-19 November 2008, Washington, D.C.

"Neuroscience 2008" --- The 38th annual meeting of the Society for Neuroscience, is scheduled for 15-19 November 2008 in Washington, D.C.

The location is the Walter E. Washington Convention Center.

Conference website.

Neuropsychology Abstract of the Day: Alzheimer's Disease Drug Development

Becker RE & Greig NH. Alzheimer's disease drug development in 2008 and beyond: Problems and opportunities. Current Alzheimer Research. 2008 Aug; 5(4): 346-357.

Drug Design & Development Section, Laboratory of Neurosciences, Intramural Research Program, National Institute on Aging, National Institutes of Health, Baltimore, MD 21224, USA.

Recently, a number of Alzheimer's disease (AD) multi-center clinical trials (CT) have failed to provide statistically significant evidence of drug efficacy. To test for possible design or execution flaws we analyzed in detail CTs for two failed drugs that were strongly supported by preclinical evidence and by proven CT AD efficacy for other drugs in their class. Studies of the failed commercial trials suggest that methodological flaws may contribute to the failures and that these flaws lurk within current drug development practices ready to impact other AD drug development [1]. To identify and counter risks we considered the relevance to AD drug development of the following factors: (1) effective dosing of the drug product, (2) reliable evaluations of research subjects, (3) effective implementation of quality controls over data at research sites, (4) resources for practitioners to effectively use CT results in patient care, (5) effective disease modeling, (6) effective research designs. New drugs currently under development for AD address a variety of specific mechanistic targets. Mechanistic targets provide AD drug development opportunities to escape from many of the factors that currently undermine AD clinical pharmacology, especially the problems of inaccuracy and imprecision associated with using rated outcomes. In this paper we conclude that many of the current problems encountered in AD drug development can be avoided by changing practices. Current problems with human errors in clinical trials make it difficult to differentiate drugs that fail to evidence efficacy from apparent failures due to Type II errors. This uncertainty and the lack of publication of negative data impede researchers' abilities to improve methodologies in clinical pharmacology and to develop a sound body of knowledge about drug actions. We consider the identification of molecular targets as offering further opportunities for overcoming current failures in drug development.

PMID: 18690832 [PubMed - indexed for MEDLINE]

Download the full article: Link

Aging Research

A press release from the NIH earlier today:

NIA and McKnight Brain Research Foundation Join Forces to Support Cognitive Aging Research

The Research Partnership in Cognitive Aging is a newly launched public-private effort to support current and emerging research on age-related changes in the brain and cognition. Jointly funded by the National Institute on Aging (NIA), one of the National Institutes of Health (NIH), and the McKnight Brain Research Foundation, through the Foundation for the National Institutes of Health (FNIH), this effort is expected to award an estimated $20 million in research grants over the next five years. The research partnership is aimed at expanding understanding of how we think, learn and remember with age and at developing interventions to maintain cognitive health as we grow older.


Read the full release

Neuropsychology Abstract of the Day: Patient-Reported Outcome Measurement for Fatigue

Christodoulou C, Junghaenel DU, Dewalt DA, Rothrock N, & Stone AA. Cognitive interviewing in the evaluation of fatigue items: Results from the patient-reported outcomes measurement information system (PROMIS). Quality of Life Research. 2008 Oct 12. [Epub ahead of print]

Department of Neurology, HSC T12-028, Stony Brook University, Stony Brook, NY, 11794-8121.

OBJECTIVES: Cognitive Interviewing (CI) is a technique increasingly used to obtain respondent feedback on potential items during questionnaire development. No standard guidelines exist by which to incorporate CI feedback in deciding to retain, revise, or eliminate potential items. We used CI in developing fatigue items for the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative. Our aims were to describe the CI process, formally evaluate the utility of decisions made on the basis of CI, and offer suggestions for future research. METHODS: Participants were 22 patients with a diverse range of chronic health conditions. During CI, each participant provided feedback on a series of items. We then reviewed the CI data and decided whether to retain, revise, or eliminate each potential item. Following this, we developed or adopted three quantitative methods to compare retained versus eliminated items. RESULTS: Retained items raised fewer serious concerns, were less likely to be viewed as non-applicable, and were less likely to display problems with clarity or to make incorrect assumptions about respondents. CONCLUSIONS: CI was useful in developing the PROMIS fatigue items and the methods used to judge CI for the present item set may be useful for future investigations.

PMID: 18850327 [PubMed - as supplied by publisher]

===

Additional information about "cognitive interviewing" may be found here: link

Election Day in Canada

Today is election day in Canada. Vote!

Here is a discussion of one of the health care issues in Canada: a shortage in the number of physicians:

From The CBC:

Why MDs are scarce and what can be done about it
Read the article

Internet Use Good For Brain Circuitry, As Well As For The WWW

From The BBC:

Internet use 'good for the brain'
Read the full article

[snip]

Lead researcher Professor Gary Small said: "The study results are encouraging, that emerging computerized technologies may have physiological effects and potential benefits for middle-aged and older adults.

"Internet searching engages complicated brain activity, which may help exercise and improve brain function."

The latest study was based on 24 volunteers aged between 55 and 76. Half were experienced internet users, the rest were not.

Each volunteer underwent a brain scan while performing web searches and book-reading tasks.

Both types of task produced evidence of significant activity in regions of the brain controlling language, reading, memory and visual abilities.

However, the web search task produced significant additional activity in separate areas of the brain which control decision-making and complex reasoning - but only in those who were experienced web users.

The researchers said that compared with simple reading, the internet's wealth of choices requires that people make decisions about what to click on in order to get the relevant information.

[snip]

Neuropsychology Abstract of the Day

Tinetti ME, McAvay GJ, Fried TR, Allore HG, Salmon JC, Foody JM, Bianco L, Ginter S, & Fraenkel L. Health outcome priorities among competing cardiovascular, fall injury, and medication-related symptom outcomes. Journal of the American Geriatrics Society. 2008 Aug; 56(8): 1409-1416. Epub 2008 Jul 24.

Department of Internal Medicine and Epidemiology, New Haven, Connecticut 06504, USA.

OBJECTIVES: To determine the priority that older adults with coexisting hypertension and fall risk give to optimizing cardiovascular outcomes versus fall- and medication symptom-related outcomes. DESIGN: Interview. SETTING: Community. PARTICIPANTS: One hundred twenty-three cognitively intact persons aged 70 and older with hypertension and fall risk. MEASUREMENTS: Discrete choice task was used to elicit the relative importance placed on reducing the risk of three outcomes: cardiovascular events, serious fall injuries, and medication symptoms. Risk estimates with and without antihypertensive medications were obtained from the literature. Participants chose between 11 pairs of options that displayed lower risks for one or two outcomes and a higher risk for the other outcome(s), versus the reverse. Results were used to calculate relative importance scores for the three outcomes. These scores, which sum to 100, reflect the relative priority participants placed on the difference between the risk estimates of each outcome. RESULTS: Sixty-two participants (50.4%) placed greater importance on reducing risk of cardiovascular events than reducing risk of the combination of fall injuries and medication symptoms; 61 participants did the converse. A lower percentage of participants with chronic obstructive pulmonary disease (P=.02), unsteadiness (P=.02), functional dependency (P=.04), lower cognition (P=.02) and depressive symptoms (P=.03) prioritized cardiovascular outcomes over fall injuries and medication symptoms than did participants without these characteristics. CONCLUSION: Interindividual variability in the face of competing outcomes supports individualizing decision-making to individual priorities. In the current example, this may mean forgoing antihypertensive medications or compromising on blood pressure reduction for some individuals.

Upcoming Event: 06 October 2008, Stockholm

From the Nobel Prize website:

Announcement of the Nobel Prize in Physiology or Medicine

The names of the year's Nobel Laureates in Physiology or Medicine are announced during a press conference at the Nobel Forum, Karolinska Institutet in Stockholm. The announcement is webcast live here at Nobelprize.org!

The 2008 Nobel Prize in Physiology or Medicine will be announced on Monday, October 6, 11:30 a.m. CET (at the earliest).

Biotech: Link Medicine and Neurodegenerative Disorders

From a company press release:

September 30, 2008

Media Contact:
Greg Kelley, Feinstein Kean Healthcare
(+++) +++-++++

Link Medicine Completes $40 million Series C Financing to Accelerate Development of First Disease-Modifying Treatments for Neurodegenerative Disorders

Co-led by Clarus Ventures and SV Life Sciences,the Financing will Advance Preclinical and Clinical Programs

CAMBRIDGE, Mass. - Link Medicine Corporation, a privately held biotechnology company advancing novel approaches for the treatment of neurodegenerative diseases, announced today that it has obtained $40 million of Series C equity financing to help move its lead preclinical programs into human clinical testing. The round was funded by two leading biotechnology investors - Clarus Ventures and SV Life Sciences.

Link Medicine, founded in March 2005, is focused on developing the first disease-modifying therapies for the treatment of several neurodegenerative diseases - including Alzheimer's, Parkinson's, Huntington's, and Amyotrophic Lateral Sclerosis (ALS). The company is pursuing innovative approaches to target a common feature of these disorders - the buildup in nerve cells of incorrectly folded, aggregated and ultimately neurotoxic proteins.

Link Medicine's development programs build on groundbreaking discoveries made in the laboratory of Link Medicine's Chief Scientific Officer Peter T. Lansbury, Jr., Ph.D., a professor of neurology at Harvard Medical School, and Director of the Morris K. Udall Research Center of Excellence in Parkinson's Disease at Brigham and Women's Hospital. Dr. Lansbury is a leader in the scientific understanding of protein misfolding and aggregation in neurodegeneration.

"Despite advances in our understanding how these conditions progress, Alzheimer's disease and Parkinson's disease continue to exert a devastating toll on patients and their families," said Adam J. Rosenberg, Link Medicine's Chief Executive Officer. "Link Medicine was established to bring sharp focus to the most pressing need these patients face - for therapies not only designed to alleviate disease symptoms, but to modify the course of the disease. The strong backing of Clarus Ventures and SV Life Sciences both validates the progress we have made to date, and accelerates our path to the clinic."

Michael Ross, Managing Partner of SV Life Sciences, said: "The company's scientific platform is unique because of its potential applicability across a wide spectrum of conditions, including more prevalent conditions like Alzheimer's and Parkinson's, and a wide range of orphan indications where protein misfolding and aggregation play a critical role."

Nick Galakatos, Managing Director of Clarus Ventures added: "The approach taken by Link to modify the course of neurodegenerative disease is a novel way to tackle Alzheimer's disease and related disorders. It is particularly attractive because it can be potentially used as a monotherapy, or as a complementary combination with other medicines."

As of the closing of the Series C financing, the Link Medicine Board of Directors is comprised of the following members:

Nick Galakatos, Managing Director, Clarus Ventures
David Guyer, Venture Partner, SV Life Sciences
Peter Lansbury, Chief Scientific Officer
Adam Rosenberg, Chief Executive Officer
Michael Ross, Managing Partner, SV Life Sciences
Edward Scolnick, Director of Psychiatry Initiative at the Broad Institute


About Link Medicine

Link Medicine is advancing disease-modifying technologies targeted at Alzheimer's, Parkinson's and other neurodegenerative diseases where current symptomatic therapies are limited in efficacy or duration, and at orphan indications which lack any meaningful symptomatic treatments. Link was founded by Chief Scientific Officer Peter T. Lansbury, Jr., a leading neuroscience researcher from Harvard Medical School and Brigham & Women's Hospital with a focus on protein misfolding and aggregation in neurodegeneration. The founding investment in Link was made by Edward I. Rudman, a prominent Boston-based business executive and philanthropist, who previously served as Chairman of the Board of Trustees of Beth Israel Hospital in Boston. Link has raised a total of $56.5 million in equity financings to date. Major investors include Clarus Ventures, SV Life Sciences, Endurance Investments Limited, Biogen Idec New Ventures, and private individuals. Link is based in Cambridge, MA.

Neuropsychology Abstract of the Day: Cross-Cultural Distance Continuing Education for Physicians

Llambí L, Margolis A, Toews J, Dapueto J, Esteves E, Martínez E, Forster T, López A, & Lockyer J. Distance education for physicians: Adaptation of a Canadian experience to Uruguay. Journal of Continuing Education for Health Professionals. 2008 Spring; 28(2): 79-85.

EviMed, Montevideo, Uruguay.

INTRODUCTION: The production of online high-quality continuing professional development is a complex process that demands familiarity with effective program and content design. Collaboration and sharing across nations would appear to be a reasonable way to improve quality, increase access, and reduce costs. METHODS: In this case report, the process of adapting and modifying a course to improve the management of Alzheimer's disease developed for the Canadian context for use in Uruguay is described. RESULTS: Both quantitative and qualitative data on the process are shown. The original course was developed by the University of Calgary in the 1990s, and taught initially face to face and later online. The adaptation included using a distance education system developed and widely used in Uruguay, called eviDoctor. DISCUSSION: The key aspects of transforming this course from one country to another with different resources, health care systems, culture, and language are analyzed. Problems encountered are described, as well as their possible solutions.

Neuropsychology Abstract of the Day: Post-operative Pain, Cognition, and PCA Techniques

Benzion Beilin; Dan Hoofien; Ravit Poran; Inbal Gral; Galina Grinevich; Berta Butin; Eduard Mayburd; & Yehuda Shavit. Comparison of two patient-controlled analgesia techniques on neuropsychological functioning in the immediate postoperative period. Journal of Clinical and Experimental Neuropsychology, Volume 30, Issue 6, August 2008, 674-682.

Pain may contribute to cognitive decline, which is a common complication in the early postoperative period. We compared the effects of two common pain management techniques, intravenous patient-controlled analgesia (PCA-IV) and patient-controlled epidural analgesia (PCEA), on cognitive functioning in the immediate postoperative period. Patients hospitalized for elective surgery were randomly assigned to one of the treatment groups (30 patients per group). A battery of objective, standardized neuropsychological tests was administered preoperatively and 24 hours after surgery. Pain intensity was also evaluated. Nonoperated volunteers served as controls. Patients of the PCA-IV group exhibited significantly higher pain scores than did patients of the PCEA group. PCA-IV patients exhibited significant deterioration in the postoperative period in all the neuropsychological measures, while the PCEA patients exhibited significant deterioration only in one cognitive index, compared to controls.

Keywords: Cognitive function; Local anaesthetics; Opiates; PCA-IV; PCEA; Postoperative pain

Upcoming Event: NYC, 22-25 October 2008

The annual meeting of the National Academy of Neuropsychology (NAN) occurs next month in midtown Manhattan. Here is the conference's webpage: Link

Brain Banks

From the CBC:

Brain banks: Crucial for research, clamouring for donors
Last Updated: Monday, September 22, 2008 | 7:56 AM ET
By Gloria Troyer
CBC News
Read the full article

[snip]

Brain banks. The work they do is not widely publicized — most people who consider signing donor cards think along the lines of organs such as the hearts and kidneys for transplant — but it's crucial for many researchers trying to understand the causes and characteristics of myriad diseases.

"Brain donations and brain banks are absolutely essential to neurological and psychiatric research," says Dr. Margaret Fahnestock, professor of neuroscience in the department of psychiatry and behavioural neurosciences at McMaster University in Hamilton.

"One of the main reasons is that there are few to no good cellular or animal models of most neuropsychiatric conditions — schizophrenia and autism, for example," she says. "This is because we currently have a poor understanding of the cellular and molecular basis of most neuropsychiatric disorders."

Fahnestock says that in light of the lack of good experimental models, one of the best ways to make progress in understanding these disorders — and thereby to make progress in prevention or therapy — is to compare the chemistry and structure of normal and abnormal human brains.

"Thus, the generosity of donors of both normal and abnormal brains is critical to our research effort," she says.

[snip]

Neuropsychology Abstract of the Day: Epilepsy

Frings L, Wagner K, Maiwald T, Carius A, Schinkel A, Lehmann C, & Schulze-Bonhage A. Early detection of behavioral side effects of antiepileptic treatment using handheld computers. Epilepsy and Behavior. 2008 Aug; 13(2) :402-406.

Epilepsy Center, University Hospital of Freiburg, Freiburg, Germany.

OBJECTIVE: Treatment-emergent side effects are frequent events, particularly during the uptitration of antiepileptic drugs. So far, monitoring of such adverse events in outpatients has often been limited to intervals of weeks or months. We here report the application of a new device for temporally fine-grained assessment of objective well-being and cognitive performance using personal digital assistants (PDAs). METHODS: Twenty adult patients with epilepsy participated in this pilot study. Ten received add-on treatment with levetiracetam. Ten patients with constant medication served as a control group. Differences between groups with respect to self-rated cognitive condition, psychophysical condition, aggressiveness, and cognitive test performance in a concentration test assessed three times daily (morning, early afternoon, and evening), over the course of 6 days, were analyzed. RESULTS: Levetiracetam-treated patients manifested an early augmentation of self-rated aggressiveness, which increased in intensity over the course of days. Aggressiveness reached a maximum in the early afternoon across days. There were no major changes in cognitive performance, except for an increase in morning performance in the control group. CONCLUSIONS: This study demonstrates the feasibility of a new method of ambulatory assessment of behavioral and cognitive data during titration of antiepileptic drugs. Significant changes in aggressiveness under add-on treatment with levetiracetam were found to be dependent on the time of assessment during the day. These results suggest that PDA-based ambulatory monitoring of patients with epilepsy may be a promising tool for early detection of drug-related side effects and, thus, may constitute a significant improvement in patient care.

World Alzheimer's Day

Today is World Alzheimer's Day.

Quality Assurance in Clinical Trials

Public release date: 21-Sep-2008

American Society for Therapeutic Radiology and Oncology

Quality assurance programs improve clinical trials

Boston – Quality assurance programs like the one at the Quality Assurance Review Center (QARC) in Worcester, Mass., strengthen the quality of clinical trials, including cooperative groups conducting National Cancer Institute-supported clinical trials, thereby improving the standard of care in cancer patients, according to a study presented September 21, 2008, at the American Society for Therapeutic Radiology and Oncology's 50th Annual Meeting in Boston.

The Quality Assurance Program, provided by QARC at the University of Massachusetts Medical School, was founded in 1980. The program's services include site credentialing to ensure that those looking to conduct clinical trials have the expertise, equipment and tools necessary to properly participate in research trials. The Quality Assurance Program also establishes benchmarks to monitor the ongoing trials and provide feedback to the physicians conducting the trials. This monitoring helps ensure that patients get the best treatments possible while making certain that the data obtained from the trials are valid and statistically significant.

From 2003 to present, QARC performed reviews on radiation therapy protocols for 6,449 patients enrolled in NCI-supported clinical trials. Cases are reviewed prior to or very early in the radiation therapy course, so that modifications in treatment can be implemented to make the treatment compliant with the study requirements. This study shows that this improved the overall quality of the clinical trial and its potential outcomes.

"Clinical trials are one the most important tools that the cancer research community has to evaluate treatments and protocols in an effort to cure cancer" T.J. FitzGerald, M.D., a study author and a radiation oncologist at QARC, said. "This study shows that a quality assurance program, like ours at QARC, can help cancer researchers conduct better clinical trials. This in turn helps patients get the best treatments possible, while recording the data in a way to help other cancer patients and further help the cancer community better understand what treatments work best."