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Articles by Lon S. Schneider
Total Records ( 5 ) for Lon S. Schneider
  Lon S. Schneider , Richard E. Kennedy and Gary R. Cutter
  Background: Low cerebrospinal fluid (CSF) amyloid-β1-42 concentration and high total-tau/Aβ1-42 ratio have been recommended to support the diagnosis of prodromal Alzheimer's disease (AD) in patients with amnestic mild cognitive impairment (aMCI) and also to select patients for clinical trials (Shaw et al, Ann Neurol 2009;65:403–13; Dubois et al, Lancet Neurol 2007;6:734–46). Methods: We tested this recommendation with clinical trials simulations using patients from the Alzheimer Disease Neuroimaging Initiative who fulfilled the following entry criteria: (1) aMCI, (2) aMCI with CSF Aβ1-42 ≤192 mg/mL, (3) and aMCI with total-tau/Aβ1-42 >0.39. For each criterion, we randomly resampled the database obtaining samples for 1000 trials for each trial scenario, planning for 1 or 2 year trials with samples from 50 to 400 patients per treatment or placebo group, with up to 40% dropouts, outcomes after using the AD assessment scale-cognitive subscale and clinical dementia rating scale with effect sizes ranging from 0.15 to 0.75, and calculated statistical power. Findings: Approximately 70% to 74% of aMCI patients with CSF measures met biomarker criteria. The addition of the low Aβ1-42 or high tau/Aβ1-42 requirement resulted in minimal or no increase in the power of the trials compared with enrolling aMCI without requiring the biomarker criteria. Slightly larger mean differences between the placebo and treatment groups fulfilling biomarker criteria were offset by increased outcome variability within the groups. Interpretations: Although patients with aMCI or patients with prodromal AD meeting CSF biomarkers criteria were slightly more cognitively impaired and showed greater decline than patients with aMCI diagnosed without considering the biomarkers, the requirement of biomarker-positive patients would most likely not result in more efficient clinical trials, and trials would take longer because fewer patients would be available. A CSF Aβ1-42 marker, however, could be useful as an explanatory variable or covariate when warranted by the action of a drug.
  Lon S. Schneider
  Not Available
  Lon S. Schneider and Mary Sano
  Background Eighteen-month-long randomized, placebo-controlled clinical trials are common for phase II and phase III drug development for Alzheimer's disease (AD). Yet, no 18-month trial has shown statistically significant outcomes favoring the test drug. We examined characteristics and underlying assumptions of these trials by assessing the placebo groups. Methods We searched the clinicaltrials.gov registry for randomized, placebo-controlled clinical trials for AD of at least 18-month duration and extracted demographic, clinical, and trials characteristics, and change in main outcomes from the placebo groups. We obtained additional information from presentations, abstracts, publications, and sponsors. Results Of 23 trials identified, 11 were completed and had baseline data available; nine had follow-up data available; 17 were phase III. General inclusion criteria were very similar except that minimum Mini-Mental State Examination (MMSE) scores varied from 12 to 20. Sample sizes ranged from 402 to 1,684 for phase III trials and 80 to 400 for phase II. Cholinesterase inhibitor use was from 53% to 100%, and memantine use was from 13.5% to 78%. The AD Assessment Scale-cognitive (ADAS-cog) was the co-primary outcome in all trials; and activities of daily living, global severity, or global change ratings were the other co-primaries. APOE ɛ4 genotype carriers ranged from 58% to 67%; mean baseline ADAS-cog was 17.8 to 24.2. ADAS-cog worsening in the placebo groups during 18 months ranged from 4.34 to 9.10, with standard deviations from 8.17 to 9.39, increasing during 18 months. Conclusions Inclusion criteria are essentially similar to earlier 6-month and 12-month trials in which cholinesterase inhibitors were not allowed, as were mean ADAS-cog rates of change. Yet increasing variability and relatively little change overall in the ADAS-cog placebo groups, eg, about 25% of patients do not worsen by more than 1 point, might make it more unlikely than previously assumed that a modestly effective drug can be reliably recognized, especially when the drug might work only to attenuate decline in function and not to improve function. These observations would be strengthened by pooling individual trials data, and pharmaceutical sponsors should participate in such efforts.
  Zaven S. Khachaturian , Deborah Barnes , Richard Einstein , Sterling Johnson , Virginia Lee , Allen Roses , Mark A. Sager , William R. Shankle , Peter J. Snyder , Ronald C. Petersen , Gerard Schellenberg , John Trojanowski , Paul Aisen , Marilyn S. Albert , John C.S. Breitner , Neil Buckholtz , Maria Carrillo , Steven Ferris , Barry D. Greenberg , Michael Grundman , Ara S. Khachaturian , Lewis H. Kuller , Oscar L. Lopez , Paul Maruff , Richard C. Mohs , Marcelle Morrison- Bogorad , Creighton Phelps , Eric Reiman , Marwan Sabbagh , Mary Sano , Lon S. Schneider , Eric Siemers , Pierre Tariot , Jacques Touchon , Bruno Vellas and Lisa J. Bain
  Among the major impediments to the design of clinical trials for the prevention of Alzheimer's disease (AD), the most critical is the lack of validated biomarkers, assessment tools, and algorithms that would facilitate identification of asymptomatic individuals with elevated risk who might be recruited as study volunteers. Thus, the Leon Thal Symposium 2009 (LTS'09), on October 27–28, 2009 in Las Vegas, Nevada, was convened to explore strategies to surmount the barriers in designing a multisite, comparative study to evaluate and validate various approaches for detecting and selecting asymptomatic people at risk for cognitive disorders/dementia. The deliberations of LTS'09 included presentations and reviews of different approaches (algorithms, biomarkers, or measures) for identifying asymptomatic individuals at elevated risk for AD who would be candidates for longitudinal or prevention studies. The key nested recommendations of LTS'09 included: (1) establishment of a National Database for Longitudinal Studies as a shared research core resource; (2) launch of a large collaborative study that will compare multiple screening approaches and biomarkers to determine the best method for identifying asymptomatic people at risk for AD; (3) initiation of a Global Database that extends the concept of the National Database for Longitudinal Studies for longitudinal studies beyond the United States; and (4) development of an educational campaign that will address public misconceptions about AD and promote healthy brain aging.
  Lea T. Drye , Zahinoor Ismail , Anton P. Porsteinsson , Paul B. Rosenberg , Daniel Weintraub , Daniel Weintraub , Daniel Weintraub , Constantine Frangakis , Peter V. Rabins , Cynthia A. Munro , Curtis L. Meinert , D.P. Devanand , Jerome Yesavage , Jacobo E. Mintzer , Lon S. Schneider , Bruce G. Pollock and Constantine G. Lyketsos
  Background Agitation is one of the most common neuropsychiatric symptoms of Alzheimer‘s disease (AD), and is associated with serious adverse consequences for patients and caregivers. Evidence-supported treatment options for agitation are limited. The citalopram for agitation in Alzheimer‘s disease (CitAD) study was designed to evaluate the potential of citalopram to ameliorate these symptoms. Methods CitAD is a randomized, double-masked, placebo-controlled multicenter clinical trial, with two parallel treatment groups assigned in a 1:1 ratio and randomization stratified by clinical center. The study included eight recruiting clinical centers, a chair‘s office, and a coordinating center located in university settings in the United States and Canada. A total of 200 individuals having probable AD with clinically significant agitation and without major depression were recruited for this study. Patients were randomized to receive citalopram (target dose of 30 mg/d) or matching placebo. Caregivers of patients in both treatment groups received a structured psychosocial therapy. Agitation was compared between treatment groups using the NeuroBehavioral Rating Scale and the AD Cooperative Study- Clinical Global Impression of Change, which are the primary outcomes. Functional performance, cognition, caregiver distress, and rates of adverse and serious adverse events were also measured. Conclusion The authors believe the design elements in CitAD are important features to be included in trials assessing the safety and efficacy of psychotropic medications for clinically significant agitation in AD.
 
 
 
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