It looks like it was released last month. It has been getting some Canadian press this week.
It looks like it was released last month. It has been getting some Canadian press this week.
Targacept Phase 2b Clinical Trial in Alzheimer’s Disease Does Not Show Superiority of TC-1734 Over Donepezil
July 14, 2014
"Winston-Salem, NC – Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced top-line results from a Phase 2b monotherapy clinical trial of TC-1734 as a treatment for mild to moderate Alzheimer’s disease. In the trial, TC-1734 did not meet the objective of showing superiority to donepezil, the marketed medication most often prescribed for Alzheimer’s disease, after 52 weeks of treatment. The trial did not include a placebo arm and was not designed to determine whether TC-1734 is equivalent to donepezil. The co-primary endpoints for the study were measures of cognitive function and global function. Consistent with previous clinical results, TC-1734 exhibited a benign safety and tolerability profile."
Here is the press release: press release.
The original examination was created by Dr. John Hodges, who is involved with the mobile application as well. The name derives from his time at Cambridge (he is currently a lead researcher at an Australian neuroscience institute).
The website for the application is: acemobile.org.
Whether or how this impacts a couple of mobile devices in this same testing space being released by companies Cogstate and Cambridge Cognition (presumably to be sold, rather than released for free) will be very interesting to consider. The structure of the Addenbrooke's (at least its paper-and-pencil version) is different from both, in that it is a screen covering multiple cognitive domains with only a little coverage for each area, whilst the other two are comprised of multi-item selective tests of isolated domains.
Whether there will be professional "blowback" for the release of a psychological testing device in an uncontrolled environment is a broader and potential serious issue.
I am looking forward to examining the instrument and collecting documentation related to it, given the important roles that neuropsychology and neuropsychologial assessment offer in terms of understanding dementia and related cognitive impairments.
ADDENDUM: An Australian Soundcloud interview with Dr. Hodges about ACEmobile is available at this link.
Specific topics include: post-traumatic amnesia (PTA)/delirium, attention, memory, execution function, self-awareness, and communication.
Centre for Clinical Research Sörmland, Uppsala University, Uppsala, Sweden.
Objective: Self-perceived mental fatigue is a common presenting symptom in many neurological diseases. Discriminating objective fatigability from self-perceived mental fatigue might facilitate neuropsychological diagnosis and treatment programs. However clinically valid neuropsychological instruments suitable for assessment of fatigability are still lacking. The prime aim of the study was to investigate aspects of cognitive fatigability and to identify properties of neuropsychological tests suitable to assess fatigability in patients with persistent cognitive complaints after mild brain injury. Another aim was to investigate whether cognitive fatigability captured by neuropsychological measures is influenced by depression or sleep disturbances. Method: Twenty-four patients with persistent cognitive symptoms after mild traumatic brain injury (mTBI), (aged 18-51 years) and 31 healthy controls (aged 20-49 years) underwent neuropsychological testing measuring three cognitive fatigability domains: Attention fatigability was assessed using the Ruff 2 & 7 Selective Attention Test, executive fatigability using the Color Word Test (Stroop), and psychomotor fatigability using the Digit Symbol Substitution Test from the Wechsler Adult Intelligence Scale-Third Edition (WAIS-III). Subjective fatigue was measured using the Fatigue Severity Scale and a questionnaire of everyday consequences of fatigue. Depression was screened using the Hospital Anxiety and Depression Scale and sleep disturbances using the Pittsburgh Sleep Quality Index. Results: The patients reported significantly more mental fatigue and performed worse on tests of psychomotor and executive fatigability than the healthy controls. Furthermore, the cognitive fatigability measures were not influenced by depression or sleep disturbances, as was the case in self-reported fatigue. Conclusion: Tests demanding executive or simultaneous processing of several neuropsychological functions seem most sensitive in order to capture cognitive fatigability. Clinical tests that can capture fatigability enable a deeper understanding of how fatigability might contribute to cognitive complaints and problems in maintaining daily activities.
PMID: 24965830 [PubMed - as supplied by publisher]
Know your professional guidelines for doing research. In the US, know your American Psychological Association guidelines. In the UK, know your British Psychological Society guidelines. Where ever you are, know the guidelines.
More generally, there is The International Compilation of Human Research Standards - 2014, which "enumerates over 1,000 laws, regulations, and guidelines that govern human subjects research in 107 countries," The Belmont Report of 1979, and The Nuremberg Code of 1947 (yes, that Nuremberg).
As for the Facebook study, I believe that the Proceedings of the National Academy of Sciences (PNAS), the academic journal that published the study, should withdraw, dismiss, remove it. The tainted fruit of the poisonous tree.
However, despite a tepid apology from Facebook, the academic institutions and the PNAS journal still appear to be in some time-warped Nixonian "hunker down" denial mode. They should know better.
INTRODUCTION:: Traumatic brain injury results in complex cognitive sequelae. However, clinicians have difficulty implementing the available evidence. An international group of researchers and clinicians (known as INCOG) convened to develop clinical practice guidelines for cognitive rehabilitation posttraumatic brain injury.
METHODS:: The Guidelines Adaptation and Development cycle was used to derive the recommendations. Previously published cognitive rehabilitation recommendations were identified and tabulated. An expert panel met to select appropriate recommendations. Afterward, the team enhanced the recommendations by reviewing available literature. To address shortfalls of previous guidelines, the team developed decision algorithms incorporating the recommendations based on inclusion and exclusion criteria of published trials and expert opinion. The team then prioritized the recommendations for implementation and developed audit criteria to evaluate adherence to best practice.
RESULTS:: The team recommends that individuals have detailed assessments of cognition after resolution of posttraumatic amnesia. Cognitive assessment and rehabilitation should be tailored to the patient's neuropsychological profile, premorbid cognitive characteristics, and goals for life activities and participation. Clinical algorithms and audit tools to evaluate current practice are provided.
CONCLUSION:: Cognitive rehabilitation should be offered to select individuals with traumatic brain injury. These guidelines provide assistance to clinicians who want to provide evidence-based care.
PMID: 24984093 [PubMed - as supplied by publisher]
Here is the course's description: click here.
It is well worth your time on its next offering, so keep it in mind!
Journal of the International Neuropsychological Society special series validates element of NIH Toolbox
An eight-essay collection of articles in the Journal of the International Neuropsycholoigcal Society confirms the validity and reliability of the Cognition Battery element of the National Institutes of Health (NIH) Toolbox for the Assessment of Neurological and Behavioral Function
27 June 2014
Childhood cancer survivors are at risk for long-term neurocognitive and psychosocial morbidities. Research has seldom examined the relationship between these morbidities; thus, little empirical evidence exists concerning overall salience and how morbidities converge to impair day-to-day functioning. An increased understanding of functional impairment resulting from the pediatric cancer experience can inform early risk identification as well as sources for intervention. The purpose of this study was to characterize the frequency/severity of functional impairment and identify significant neurocognitive and psychosocial determinants of functional impairment.
Fifty child-parent dyads were enrolled. Children were aged 7-19 years who were at least 2 years postdiagnosis with leukemia/lymphoma and were recruited through a pediatric oncology late effects clinic. Parents completed questionnaires, rating their own adjustment to their child's illness as well as their child's level of functional impairment, while a brief neuropsychological exam was administered to children.
Twenty-six percent of the sample evidenced clinically significant functional impairment. Regression analyses indicated that neurocognitive deficits did not predict functional impairment, whereas parental stress was a significant predictor.
Although children demonstrated both neurocognitive deficits and functional impairments, results favor psychosocial factors, such as parental stress, as a predictor of overall functional impairment. The implications of this study suggest that late effects aggregate to impact day-to-day functioning in pediatric cancer survivor populations and parental stress may serve as a marker for heightened risk. The results suggest that broader functional domains, especially school and self-care domains, should be evaluated and considered when identifying potential targets for psychosocial interventions.
Copyright © 2014 John Wiley & Sons, Ltd.
PMID: 24817624 [PubMed - as supplied by publisher]