How Much Risk Will Patients Accept?

Research and Development by mthibault on November 14, 2016

A pilot project focused on Parkinson's disease will use patient preference and risk tolerance to set statistical significance levels in clinical trial design. How will this impact the future of medical device trials?

Marie Thibault

A first-of-its-kind research project is aiming to translate patients' risk tolerances and preferences into innovative clinical trial designs. That means that statistical significance levels could differ based on a disease's severity and patients' willingness to accept riskier treatments.

The collaboration between the Medical Device Innovation Consortium (MDIC), The Michael J. Fox Foundation for Parkinson's Research (MJFF), FDA, RTI Health Solutions, and the Massachusetts Institute of Technology (MIT) is starting with a pilot focused on Parkinson's disease. According to the MDIC release, the goal is to use patient preference information to determine clinical trial design significance levels—what MDIC termed "therapy-specific patient-values."

The effort is part of an industry-wide shift toward seeking and using patient input. FDA finalized guidance on how patient preference information can be used in regulatory decision making earlier this year; CDRH has a Patient Preference Initiative; and there have been various efforts to speed the regulatory process for breakthrough devices. 

Learn about "The Crossroads of 3-D Printing Medical Devices and Legal Principles" at BIOMEDevice San Jose, December 7-8. 

http://biomedevicesj.mddionline.com/_mc=arti_x_mddir_edt_aud_thibault_mddir_med_38_x-mdicpatientpref

While patient preference has been used for retrospective trial analysis, this will be the first prospective use of patient preference.

Stephanie Christopher, program manager, patient centered benefit-risk outcome at MDIC, and Dawn Bardot, vice president of technology innovation at MDIC, explained in an e-mail to MD+DI that this project is turning the idea of patient centricity into a concrete reality. "This is one place along the total product lifecycle in which patient centricity can be incorporated," they wrote.

The research will revolve around a hypothetical medical device to treat Parkinson's disease. RTI Health Solutions will work first with a focus group of representatives from the MJFF Patient Council to learn about patient risk preferences, the balance of risks and benefits patients are willing to experience, and what would be most valuable to them, according to Christopher and Bardot. That knowledge will then be used to design a patient preference survey that will be sent to thousands of patients using the MJFF Fox Insight platform, they explained. In addition, a team from MIT will use Bayesian analysis to determine what the trial endpoints and p-value significance levels should be, based on the responses collected from patients.

"People with a disease like Parkinson's can be more than research subjects; we can be partners in the design and focus of clinical trials. We welcome this opportunity to work with MDIC, the FDA and other partners to create a mechanism for the patient voice to be heard," Anne Cohn Donnelly, co-chair of the MJFF Patient Council working group for this project, said in an MJFF blog post.

Will this change medical device trials as we know them? The project is an opportunity for MDIC to evaluate stakeholders' interest in these types of trials, Christopher and Bardot wrote. "At the end of the day, we want to create scientifically rigorous and reproducible methods for incorporating patient preferences into regulatory decision-making and across the medical device product development lifecycle," they added.

According to FDA's patient preference information guidance, any patient preference information used during the regulatory decision making process will be described in device product labeling. 

"By designing clinical trials that reflect patients’ urgency and risk tolerance, scarce resources can be allocated more efficiently, bringing more therapies to more patients faster and cheaper," Christopher and Bardot told MD+DI.

Marie Thibault is managing editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @MedTechMarie.

[Image courtesy of KHUNASPIX/FREEDIGITALPHOTOS.NET]

http://www.mddionline.com/blog/devicetalk/how-much-risk-will-patients-accept-11-14-16

BERG Presents Data Uncovering a Novel Contributor to Parkinson’s Disease at Society for Neuroscience 2016 Meeting

BOSTON, Nov. 14, 2016 

BERG, a biopharmaceutical company uncovering health solutions through a data-driven, biological research approach, today unveiled data from a recent study that clarified the role of a genetic mutation in the LRRK2 gene, which represents a major risk factor for both sporadic and familial Parkinson’s disease (PD), at the Society for Neuroscience’s Neuroscience 2016 meeting. The study utilized BERG’s Interrogative Biology ® platform with the aim to understand the mechanism behind LRRK2-driven PD, and the resulting analysis identified p53-inducible gene 3 (PIG3) as a novel regulator of cell death in Parkinson’s disease. The discovery may serve as a novel drug target for development of new therapeutics for PD.

Through BERG’s Interrogative Biology® platform, the study analyzed data points of skin cells from PD patients obtained from BERG’s partner The Parkinson’s Institute to understand the neurological disorder. This study also showcased the predictive power of Interrogative Biology® as a discovery tool for mining fundamental biology from peripheral cells to better understand inherent molecular drivers of neurodegenerative disease.

We’re excited to continue to push the boundaries of what’s possible with the Interrogative Biology® system,” said BERG CEO, co-founder and president Niven R. Narain. “The Interrogative Biology® system is able to fill the knowledge gap through seemingly unrelated patient biology – as in this instance, where we used skin cells to discover key insights about a neurological disorder.  In addition, unraveling novel biology into the CNS disease space where the basic understanding of diseases like PD is not fully elucidated offers the field insight that may lead to developing disease modifying drugs.”

The BERG Interrogative Biology® platform maps patient disease states by interrogating both the healthy and diseased states of the patient biology and data to uncover a network of causal relationships between historical, molecular and other data types and patient outcomes. BERG will further explore mechanisms associated with LRRK2 and PIG3, and develop additional uses for the Interrogative Biology ® platform to understand the mysteries associated with Parkinson’s disease, and other neurodegenerative diseases, to develop safe and effective treatment pathways.

“I am very encouraged by the progress of the BERG Interrogative Biology® system as not only did it identify PIG3 as a novel contributor to cell death in PD patients, it also uncovered that a LRRK2 mutation leads to a core abnormality in GBA-related pathways,” stated Eric Nestler, MD, PhD, Dean for Academic and Scientific Affairs, Nash Family Professor of Neuroscience and Director of the Friedman Brain Institute at the Icahn School of Medicine at Mount Sinai.

More information on BERG’s session 287.09 – Interrogative Biology®identifies p53-inducible gene 3 (PIG3) as a potential contributor to LRRK2-mediated neuronal cell death in Parkinson’s Disease: http://www.abstractsonline.com/pp8/index.html#!/4071/presentation/32939

About BERG

BERG is a clinical-stage company disrupting and re-defining the approach to drug discovery, research and development through its Interrogative Biology® platform. Its platform identifies therapies and biomarkers by applying algorithm- and probability-based artificial intelligence to analyze large numbers of patients’ genotypic, phenotypic and other characteristics. BERG’s platform operates at the intersection of biology, technology and artificial intelligence analytics and integrates many data characteristics regarding patients’ lifestyles, demographics and biology.  BERG believes this allows the company to better understand patients’ disease profiles and consequently to identify and reveal molecular signatures to guide and accelerate product candidate selection and development. By identifying biomarkers and patient characteristics that are unique to the disease state, BERG is able to identify novel therapeutic product candidates and develop companion diagnostics to enhance specificity in its drug development process. 

BERG has leveraged its Interrogative Biology® platform to develop a robust pipeline of therapeutic product candidates and diagnostics in cancer, diabetes and neurology. Its lead drug, BPM-31510 (IV), has the potential to slow or reverse cancer cell growth by changing a hypothesized fundamental driver of many different types of cancer.  BERG has initiated a Phase II clinical trial for BPM-31510 (IV) in advanced pancreatic cancer in combination with a common cancer drug, among other ongoing and planned trials for BPM-31510 (IV) in various oncological indications.

For additional information, please visit www.BERGhealth.com.

http://www.prnewswire.com/news-releases/berg-presents-data-uncovering-a-novel-contributor-to-parkinsons-disease-at-society-for-neuroscience-2016-meeting-300362283.html

What does it take to make a memory? Study says new proteins

NEUROSCIENCE NEWSNOVEMBER 10, 2016

Summary: A new study identifies a sub region of the brain that works to form a particular kind of memory: fear-associated with a specific environmental cue or “contextual fear memory.”

Source: Scripps Research Institute.

“Much is still unknown about the identities of proteins synthesized to produce long-term memory,” Puthanveettil said. “The most striking observation from the new study is that the medial prefrontal cortex is the site of this early protein synthesis. We have also identified what proteins are newly synthesized in the medial prefrontal cortex.” Neurosciencenews image is for illustrative purposes only.

While the romantic poets’ idea of memories being akin to spirits may have poetic merit, the scientists’ perspective is that memories are concrete, physical entities that can be visualized within various regions of the brain.

Scientists from the Florida campus of The Scripps Research Institute (TSRI) have now for the first time identified a sub-region in the brain that works to form a particular kind of memory: fear-associated with a specific environmental cue or “contextual fear memory.”

The study, recently published in the journal Biological Psychiatry Cognitive Neuroscience and Neuroimaging, was led by TSRI Associate Professor Sathyanarayanan V. Puthanveettil.

“Much is still unknown about the identities of proteins synthesized to produce long-term memory,” Puthanveettil said. “The most striking observation from the new study is that the medial prefrontal cortex is the site of this early protein synthesis. We have also identified what proteins are newly synthesized in the medial prefrontal cortex.”

In particular, the study showed new protein synthesis in a specific sub-region of the prefrontal cortex known in rodents as the prelimbic. In humans, this area corresponds to the anterior cortex, which has been linked to processing emotional responses.

Initially, Puthanveettil and his colleagues ignored the medial prefrontal cortex because no one believed that it had anything to do with early encoding of long term memories.

However, when they closely examined the effects on the brain of conditioning rodents with a mild foot shock, the scientists found several messenger RNAs recruited to polyribosomes in the medial prefrontal cortex—a clear indication of new protein synthesis there.

Puthanveettil and his colleagues also discovered that if they inhibited new protein synthesis in the prelimbic region right after fear conditioning took place, those memories did not form. But if the researchers waited just a few hours, inhibiting protein synthesis in prelimbic cortex had no impact and the memories took hold. There is temporal and spatial regulation of new protein synthesis in the medial prefrontal cortex.

“It may be that the first wave of protein synthesis is critical for encoding contextual fear memory, while second wave in other sub-regions is important for memory storage,” he said.

It remains to be determined if other sub-regions of the cortex are also be involved in the synthesis of memory proteins.

“The medial prefrontal cortex has many sub-regions,” said TSRI Senior Research Associate Bindu L. Raveendra, co-first author of the study with Valerio Rizzo, Khalid Touzani and Supriya Swarnkar, all of TSRI at the time of the study. “But the specific roles of these sub-regions in encoding, expression and retrieval, as well as their underlying molecular mechanisms, remain to be unraveled.”

ABOUT THIS MEMORY RESEARCH ARTICLE

Other authors of the study, “Encoding of Contextual Fear Memory Requires De Novo Proteins in The Prelimbic Cortex,” include Beena M. Kadakkuzha and Xin-An Liu of TSRI; Joan Lora and Robert W. Stackman of Florida Atlantic University; and Chao Zhang and Doron Betel of Weill Cornell Medical College.

Funding: The study was supported by the Whitehall Foundation, the National Institutes of Health (grant number 1R21MH096258) and the State of Florida.

Source: Scripps Research Institute

Image Source: This NeuroscienceNews.com image is in the public domain.

Original Research: Abstract for “Encoding of Contextual Fear Memory Requires De Novo Proteins in The Prelimbic Cortex” by Valerio Rizzo, Khalid Touzani, Bindu L. Raveendra, Supriya Swarnkar, Joan Lora, Beena M. Kadakkuzha, Xin-An Liu, Chao Zhang, Doron Betel, Robert W. Stackman, and Sathyanarayanan V. Puthanveettil in Biological Psychiatry Cognitive Neuroscience and Neuroimaging. Published online October 21 2016 doi:10.1016/j.bpsc.2016.10.002

Abstract

Encoding of Contextual Fear Memory Requires De Novo Proteins in The Prelimbic Cortex

Background

Despite our understanding of the significance of the prefrontal cortex in the consolidation of long-term memories (LTM), its role in the encoding of LTM remains elusive. Here we investigated the role of new protein synthesis in the mouse medial prefrontal cortex (mPFC) in encoding contextual fear memory.

Methods

Because a change in the association of mRNAs to polyribosomes is an indicator of new protein synthesis, we assessed the changes in polyribosome-associated mRNAs in the mPFC following contextual fear conditioning (CFC) in the mouse. Differential gene expression in mPFC was identified by polyribosome profiling (n = 18). The role of new protein synthesis in mPFC was determined by focal inhibition of protein synthesis (n = 131) and by intra-prelimbic cortex manipulation (n = 56) of Homer 3, a candidate identified from polyribosome profiling.

Results

We identified several mRNAs that are differentially and temporally recruited to polyribosomes in the mPFC following CFC. Inhibition of protein synthesis in the prelimbic (PL), but not in the anterior cingulate cortex (ACC) region of the mPFC immediately after CFC disrupted encoding of contextual fear memory. Intriguingly, inhibition of new protein synthesis in the PL 6 hours after CFC did not impair encoding. Furthermore, expression of Homer 3, an mRNA enriched in polyribosomes following CFC, in the PL constrained encoding of contextual fear memory.

Conclusions

Our studies identify several molecular substrates of new protein synthesis in the mPFC and establish that encoding of contextual fear memories require new protein synthesis in PL subregion of mPFC.

“Encoding of Contextual Fear Memory Requires De Novo Proteins in The Prelimbic Cortex” by Valerio Rizzo, Khalid Touzani, Bindu L. Raveendra, Supriya Swarnkar, Joan Lora, Beena M. Kadakkuzha, Xin-An Liu, Chao Zhang, Doron Betel, Robert W. Stackman, and Sathyanarayanan V. Puthanveettil in Biological Psychiatry Cognitive Neuroscience and Neuroimaging. Published online October 21 2016 doi:10.1016/j.bpsc.2016.10.002

http://neurosciencenews.com/new-protein-memory-5473/

Living with Parkinson's disease,Susan Speicher, left, Ms. Speicher's

November 13, 2016

Susan Speicher, left, and Darcy Blake in Ms. Speicher's home exercise studio. Ms. Speicher says exercise is vital to those with Parkinson's disease. (Photo by Michelle Le/The Almanac.)

Susan Speicher has Parkinson's disease, a progressive neurological disorder that, as of now, has no cure, but please don't call her "the woman with Parkinson's."

"Parkinson's isn't who I am, it's just something I have," she says. "I have gray hair, and a small dog, and Parkinson's."

Ms. Speicher, a widow who moved to Atherton from Woodside about 12 years ago, is part of a group called Parkinson's Women Support that meets monthly in Palo Alto. The group says its goal is to provide encouragement, camaraderie and compassion, with a focus on living life fully despite -- or with -- Parkinson's. 

The group started in 2008 and has about 70 members, about 25 of whom meet for a monthly luncheon.

"Parkinson's is something you live with. We're a group of women who want you to live the best you can with it. And to laugh and be supported. To be encouraged, exercise and to know that you're not alone," Ms. Speicher says. 

"We're not a formal organization. We're not dispensers of medical advice," she says. "We're someone who's been through it, who wants to let you know it will be all right."

At ParkinsonsWomen.com, the group has a blog and links to its Facebook page, both maintained by Darcy Blake, a Redwood City resident with Parkinson's who is the communications director for Menlo College in Atherton.

After Ms. Sp

eicher was diagnosed at age 62, about seven years ago, she wasn't quite so accepting.

"I threw myself down on the floor," she says of the day she acknowledged the correctness of her longtime suspicion and her doctor's diagnosis that she had Parkinson's disease. 

But then, she says, "I decided I better get off the floor." 

Ms. Speicher says her first impulse was to find a cure for the disease. But with a background in education, not medicine, she soon had to acknowledge that wasn't likely. 

"That's when I picked up the pace of my volunteer work," she says. 

Part of that volunteer effort was to help organize an Oct. 29 seminar called "Women & PD: What's New?" in Redwood Shores. The group cut off registration at 60, but had to put out folding chairs when 70 women showed up, with one mother and daughter pair driving six hours to attend. 

At the symposium, researchers from places including Stanford University, 23andMe, the Buck Institute and the University of California San Francisco talked about the latest research in Parkinson's disease and its effects on women. 

Studies have shown that almost twice as many men as women have Parkinson's disease. "We don't know a lot about women and Parkinson's," Ms. Speicher says.

The Stanford School of Medicine's Movement Disorders Center says that Parkinson's disease affects more than 1.5 million people in the U.S. The disease, the center's website says, is the result of the loss of brain cells that produce the neurotransmitter dopamine. 

The disease is usually diagnosed in those older than 50, but as many as 20 percent of those diagnosed are under 50. 

Symptoms, according to the center's website, can include balance and posture problems, stiffness or rigidity of limbs or neck, tremors or trembling, general slowness of movement and difficulty with gait. Parkinson's patients also can be depressed or confused and have speech and writing difficulties. 

"There's no cure; there's management," Ms. Speicher says. 

"My Parkinson's is different from everybody else's Parkinson's," she says and what helps her may not help others. 

But she has learned, she says, "with the right medicine, the right exercise and the right diet, it's something you can live with." 

She quotes Michael J. Fox, perhaps the most well-known person with Parkinson's disease: "We're all going to get hit by the bus, but with Parkinson's, you can see it coming."

"I don't know how many stops that bus has before it gets to me," Ms. Speicher says. So she works at living her life to the fullest. Since March, she's been to Cuba, Argentina, Peru, Chile, Easter Island, Canada and England, plus twice to New York. 

"I don't feel blessed to have Parkinson's," she says. "I also don't feel doomed by it."

What is the same for all with Parkinson's, she says, is this: "We all need to exercise and we all need to laugh and we all need to know there's somebody out there."

Resources for those with Parkinson's disease

The Midpeninsula has lots of resources for those with Parkinson's disease and their caregivers, ranging from exercise classes to clinical trials.

Parkinson's Women Support group

ParkinsonsWomen.com and facebook.com/ParkinsonsWomen has information about the group, which holds a lunch on the third Tuesday of the month, from noon to 1:30 p.m., usually at a Palo Alto restaurant. To join the lunch, RSVP at least 5 days in advance to: sfoster@learningdesignsinc.com.

American Parkinson Disease Association (APDA) Information & Referral Center at Stanford

Parkinsons.stanford.edu has listings of support groups (including those for caregivers as well as those with Parkinson's), and information on exercise classes, on the disease and on how to sign up for an email list or quarterly newsletter.

Stanford resources include a "Dance for Parkinson's" class based on a program designed by the Mark Morris Dance Group and the Brooklyn Parkinson Group for those with Parkinson's and their friends, family and caregivers. There are also Tai chi and qigong classes for those with Parkinson's.

The Parkinson's Institute and Clinical Center, Sunnyvale

Thepi.org has a list of resources, educational programs and events, plus a place to sign up for clinical trials.

National resources online

The Michael J. Fox Foundation for Parkinson's Research

Michaeljfox.org has information, such as "Parkinson's 101" and a tool to find clinical trials. 

American Parkinson Disease Association

ADPAParkinson.org provides a way to order or download educational booklets and pamphlets and sign up for a quarterly newsletter and email list.

http://almanacnews.com/news/2016/11/12/living-with-parkinsons-disease

Brain training can help in fight against dementia: Meta-analysis

NEUROSCIENCE NEWSNOVEMBER 14, 2016

Summary: According to researchers, brain training apps can help improve mood and memory in people with mild cognitive impairment, but the training loses its effectiveness once dementia has been diagnosed.

Source: University of Sydney.

Brain training is a treatment for enhancing memory and thinking skills by practising mentally challenging computer-based exercises – which are designed to look and feel like video games. NeuroscienceNews.com image is credited to NeuroNation.

Researchers at the University of Sydney have found that engaging in computer-based brain training can improve memory and mood in older adults with mild cognitive impairment – but training is no longer effective once a dementia diagnosis has been made.

The team, comprising researchers from the Brain and Mind Centre , reviewed more than 20 years of research and showed that brain training could lead to improvements in global cognition, memory, learning and attention, as well as psychosocial functioning (mood and self-perceived quality of life) in people with mild cognitive impairment. Conversely, when data from 12 studies of brain training in people with dementia was combined, results were not positive.

The results are published today in the prestigious American Journal of Psychiatry.

Mild cognitive impairment involves a decline in memory and other thinking skills despite generally intact daily living skills, and is one of strongest risk factors for dementia. People with mild cognitive impairment are at one-in-10 risk of developing dementia within a year – and the risk is markedly higher among those with depression.

Brain training is a treatment for enhancing memory and thinking skills by practising mentally challenging computer-based exercises – which are designed to look and feel like video games.

Dr Amit Lampit from the School of Psychology, who led the study said the results showed brain training could play an important role in helping to prevent dementia.

“Our research shows that brain training can maintain or even improve cognitive skills among older people at very high risk of cognitive decline – and it’s an inexpensive and safe treatment,” Dr Lampit said.

To arrive at their conclusions, the team combined outcomes from 17 randomised clinical trials including nearly 700 participants, using a mathematical approach called meta-analysis, widely recognised as the highest level of medical evidence.

The team has used meta-analysis before to show that brain training is useful in other populations, such as healthy older adults and those with Parkinson’s disease.

“Taken together, these wide-ranging analyses have provided the necessary evidence to pursue clinical implementation of brain training in the aged-care sector – while continuing research aimed at improving training effectiveness”, Dr Lampit said.

Associate Professor Michael Valenzuela, leader of the Regenerative Neuroscience Group at the Brain and Mind Centre, believes new technology is the key to moving the field forward.

“The great challenges in this area are maintaining training gains over the long term and moving this treatment out of the clinic and into people’s homes. ” Associate Professor Valenzuela said.

“This is exactly what we are working on right now.”

Associate Professor Valenzuela is one of the leaders of the multi-million-dollar Australian Maintain your Brain trial that will test if a tailored program of lifestyle modification, including weekly brain training over four years, can prevent dementia in a group of 18,000 older adults.

ABOUT THIS ALZHEIMER’S RESEARCH ARTICLE

What is brain training?

Brain training (or more precisely computerised cognitive training or CCT) is a treatment for enhancing memory and thinking skills by practising mentally challenging exercises on computer. The exercises are designed to look and feel like video games and are based on well-established neuropsychological principles to target specific cognitive domains. Most CCT programs adapt training difficulty so the exercises become harder as performance improves and also provide feedback on progress.

What is a meta-analysis?

A meta-analysis is a statistical technique that begins by searching for all possible studies on a precise question, assessing their quality, and then mathematically combining these to produce an overall numerical result. In general, meta-analyses put more weight on larger or more precise studies and less weight on smaller, less precise studies. Conclusions from a high quality meta-analyses are therefore stronger than those from a single study or from a simple count of ‘positive’ and ‘negative’ results. Under some circumstances, meta-analysis allows a researcher to identify fundamental characteristics of the studies that are contributing to the overall pattern of results.

What’s the difference between cognitive impairment and dementia?

These concepts tend to lie along a continuum of cognitive function.

Most cognitive domains decline as we get older but there is great variability between individuals and even within our own trajectories over time. This variability increases in later life and so can make the distinction between normal and impaired, or between impaired and dementia, challenging.

Neuropsychological testing can then be useful to find out how they compare to the average person of their age, sex and level of education. If multiple tests for a given cognitive domain point to a result less than the 10th percentile, then they may have an impairment in that domain.

For a diagnosis of dementia, four main conditions need to be satisfied:

• impairment on multiple cognitive domains
• a definite decline in cognitive function
• exclusion of any possible medical causes for this decline, and
• the person is no longer able to carry out day-to-day tasks.

In practice, the last criterion – being able to do one’s daily activities independently – is pivotal to distinguishing between cognitive impairment and dementia.

Funding: The funding was provided by National Health and Medical Research Council of Australia, Australian Research Council.

Source: Vivienne Reiner – University of Sydney 

Image Source: This NeuroscienceNews.com image is credited to NeuroNation.

Original Research: Abstract for “Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis” by Nicole T.M. Hill, M.BMSc., Loren Mowszowski, D.Psych., Sharon L. Naismith, D.Psych., Verity L. Chadwick, B.Sc. (Hons.), Michael Valenzuela, Ph.D., and Amit Lampit, Ph.D. in The American Journal of Psychiatry. Published online November 14 2016 doi:10.1176/appi.ajp.2016.16030360

Abstract

Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis

Objective:

Previous meta-analyses indicate that computerized cognitive training (CCT) is a safe and efficacious intervention for cognition in older adults. However, efficacy varies across populations and cognitive domains, and little is known about the efficacy of CCT in people with mild cognitive impairment or dementia.

Method:

The authors searched Medline, Embase, PsychINFO, CINAHL, and CENTRAL through July 1, 2016, for randomized controlled trials of CCT in older adults with mild cognitive impairment or dementia. Overall cognition, individual cognitive domains, psychosocial function, and activities of daily living were pooled separately for mild cognitive impairment and dementia trials.

Results:

The overall effect on cognition in mild cognitive impairment across 17 trials was moderate (Hedges’ g=0.35, 95% CI=0.20–0.51). There was no evidence of publication bias or difference between active- and passive-controlled trials. Small to moderate effects were found for global cognition, attention, working memory, learning, and memory, with the exception of nonverbal memory, and for psychosocial functioning, including depressive symptoms. In dementia, statistically significant effects were found on overall cognition (k=11, g=0.26, 95% CI=0.01–0.52) and visuospatial skills, but these were driven by three trials of virtual reality or Nintendo Wii.

Conclusions:

CCT is efficacious on global cognition, select cognitive domains, and psychosocial functioning in people with mild cognitive impairment. This intervention therefore warrants longer-term and larger-scale trials to examine effects on conversion to dementia. Conversely, evidence for efficacy in people with dementia is weak and limited to trials of immersive technologies.

“Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis” by Nicole T.M. Hill, M.BMSc., Loren Mowszowski, D.Psych., Sharon L. Naismith, D.Psych., Verity L. Chadwick, B.Sc. (Hons.), Michael Valenzuela, Ph.D., and Amit Lampit, Ph.D. in JAmerican Journal of Psychiatry. Published online November 14 2016 doi:10.1176/appi.ajp.2016.16030360

http://neurosciencenews.com/dementia-brain-training-5497/

Aaron Latham, Leslie Stahl Husband: 5 Fast Facts You Need to Know

 November 13, 2016 By Shannon Walsh 

Journalists Aaron Latham and Lesley Stahl attend New York City Ballet’s Spring 2013 Gala at David H. Koch Theater, Lincoln Center on May 8, 2013 in New York City. (Getty)

Aaron Latham is the husband of Leslie Stahl, who will be interviewing Donald Trump in his first post-election interview tonight on 60 Minutes. Latham, himself, is a journalist, and is a regular contributor to a number of celebrated publications.

Read on to learn more about Aaron Latham, Leslie Stahl’s husband.

1. He Co-Wrote the Film Movie Urban Cowboy

Urban Cowboy is a western romantic drama starring John Travolta that was released in 1980. The inspiration for the screenplay came from Latham’s 1978 article in Esquire Magazine, about Dew Westbrook and Betty Helmer. It has been likened to Saturday Night Fever, and was directed by James Bridges (who co-wrote the screenplay with Latham.) Latham went on to co-write the book for the 2003 Broadway musical version of Urban Cowboy.

Latham, 73, was born in the small town of Spur, in West Texas, to a long line of Texas Methodists. His father, Cecil Clyde Latham, was a high school football coach, and his mother, Annie Launa, taught grammar school. He attended Amherst College for undergrad, where he worked as editor of the school’s newspaper and graduated from in 1966. He then went on to receive his PhD from Princeton.

2. He Is Fighting Parkinson’s Disease

Last year, Stahl wrote a piece about Parkinson’s titled “Fighting Back Against Parksinson’s- In the Ring”, in which she discussed a program called Rock Steady Boxing, which uses professional boxing techniques to try and reverse Parkinson’s. Latham is part of the program, along with fellow Parkinsonians ages 45 to 92. Rock Steady Boxing was developed in Indianapolis in 2006, and has since spread to over 50 gyms worldwide.

In the article, Latham is quoted as saying, “Boxing’s just the opposite of Parkinson’s. Instead of to shrink you, everything’s designed to pump you up. First of all, you get to put on these great gloves. It gives you enormous, giant hands and a different attitude toward the world. You get your physical courage back and your mental courage seems to kinda come along.” Latham’s boxing coach, Roberta Marongiu, works as a  gene therapies researcher for Parkinson’s at Will-Cornell Medical College when she isn’t coaching.

3. He Recently Finished Directing a Staged Production of ‘Golden Boy’ in Brooklyn

Latham recently finished directing Clifford Odets play, Golden Boy, staged at Gleason’s Gym in Brooklyn. The first performance of the show was in 1937, and this marks the first time the show has ever been performed in a site-specific setting.

According to Broadway World, the play was intended as a fundraising event for the Michael J. Fox Foundation and stoPD (Support and Training to Overcome Parkinson’s Disease), and starred two actors living with Parkinson’s. It also marked Latham’s theatrical directorial debut. The show ran from October 22nd to October 30th.

4. He Was an Editor for Esquire

In 1977, according to a People article, Latham was an editor for Esquire Magazine. An accomplished journalist, he has written for publications like Rolling Stone, Esquire, Talk, and The New York Times.

He and Stahl met in 1973, when Aaron was digging up Watergate anecdotes for an article. According to People.com, he was advised to contact Stahl for the project, who was “a CBS rookie covering the story” at the time. When Latham tracked down Stahl’s home number, she reportedly lashed out, saying, “How dare you call me at home? If you want to talk, call me tomorrow at the office.” Latham says he then turned on the TV to see what Stahl looked like and was struck by her beauty. People reports him as saying, “She’s so beautiful…. My heart stopped, my mouth dried up and I said, ‘What have I got myself into?’”

5. He and Stahl Have One Daughter

NEW YORK, NY – OCTOBER 25: Journalists Lesley Stahl and Aaron Latham attend the TIME’s screening of Lincoln and Q & A on October 25, 2012 in New York City. (Getty)

After meeting, Latham became New York’s Watergate reporter, and met with Stahl a number of times over the next few years. Eventually, they realized their relationship was destined for more than friendship, and Latham moved into Stahl’s Watergate apartment. In Christmas of 1976, Stahl became pregnant. Shortly after, she told People, “I wouldn’t have a child without being married. They (CBS) weren’t easy on me. I had the Korean scandal, which meant stakeouts on my feet.” Their daughter’s name is Taylor Latham.

In 2008, at age 31, Taylor opened up her own business, Our Little Barrel– a luxury line of wine-themed clothing that she and her husband designed. In an interview, Taylor told The Observer, “My grandfather owned his business at a time when you did not hand your business over to your daughter. So he sold it, but I think there was a part of my mother that always wanted her father to pass it on to her. When we called and said we’re going to do this, she was so excited.”

http://heavy.com/news/2016/11/aaron-latham-leslie-stahl-husband-who-is-married-to-urban-cowboy/

Back to the Future! Michael J. Fox Jams with Dave Matthews Band at Charity Event

NOVEMBER 13, 2016   BY BLAKE BAKKILA

JAMIE MCCARTHY/MJF 2016/GETTY

Michael J. Fox took his hosting gig to the stage for a performance with Dave Matthews at his charity event in New York on Saturday night.

The star-studded charity event, “A Funny Thing Happened on the Way to Cure Parkinson’s: An Evening of Comedy & Music to Benefit The Michael J. Fox Foundation” was co-chaired by Fox’s wife Tracy Pollan, Katie Couric and her husband John Molner, and Blake Lively and Ryan Reynolds. At one point during the night, Fox, 55, joined musical guest Dave Matthews to add a guitar riff to the renowned musician’s set.

Fox took to the stage in a white button-down and black tie, and was all smiles as he shared the stage with Matthews, who was dressed in an all-black ensemble. The musical performance was reminiscent of Fox’s iconic role as Marty McFly in Back to the Future, which featured a guitar solo by Fox during his character’s high school dance.

Fox was diagnosed with Parkinson’s disease in 1991 and went public about his illness in 1998, the same year he committed himself to the campaign for increased Parkinson’s research.

Reynolds, 40, whose father also suffers from Parkinson’s disease, teamed up with Fox about eight years ago and said his friend is “unsinkable.”

“He’s incredible in everything that he does, from the foundation to his work to his work ethic,” Reynolds told PEOPLE in 2013. “There’s a reason why everyone likes this guy so much – he’s just unsinkable.”

Video:http://people.com/celebrity/michael-j-fox-performs-charity-event/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+people%2Fstylewatch%2Fofftherack+%28PEOPLE.com%3A+Style+Watch+-+Off+The+Rack%29

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