Shau Yu Lynch
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View article: Assessment of AI‐generated digital twin (DT) methodology on reduction of treatment effect variance and potential clinical trial sample size saving using a Phase 2 trial dataset from patients with Alzheimer’s disease (AD)
Assessment of AI‐generated digital twin (DT) methodology on reduction of treatment effect variance and potential clinical trial sample size saving using a Phase 2 trial dataset from patients with Alzheimer’s disease (AD) Open
Background In Alzheimer’s Disease (AD) trials, clinical scales are used to assess treatment effect in patients. Minimizing statistical uncertainty of trial outcomes is an important consideration to increase statistical power. Machine learn…
View article: Apheleia‐001: A novel prescreening study designed to enrich and accelerate Alzheimer’s disease clinical trials by efficiently identifying trial‐eligible participants determined to have a high probability of study inclusion, including amyloid positivity
Apheleia‐001: A novel prescreening study designed to enrich and accelerate Alzheimer’s disease clinical trials by efficiently identifying trial‐eligible participants determined to have a high probability of study inclusion, including amyloid positivity Open
Background The clinical development ecosystem cannot support the current demand for participants needed in Alzheimer’s disease clinical trials which is further disrupted by: 1) high screen fail rates (≥80‐90%); 2) lengthy screening visits …
View article: Baseline characteristics for CLARITY AD: A phase 3 placebo‐controlled, double‐blind, parallel‐group, 18‐month study evaluating lecanemab (ban2401) in early Alzheimer's disease
Baseline characteristics for CLARITY AD: A phase 3 placebo‐controlled, double‐blind, parallel‐group, 18‐month study evaluating lecanemab (ban2401) in early Alzheimer's disease Open
Background Lecanemab (BAN2401) is a humanized IgG1 monoclonal antibody that preferentially targets soluble aggregated Aβ. In a recent multinational, phase 2, double‐blind, placebo‐controlled, study utilizing a Bayesian design with response…
View article: P4‐389: ELENBECESTAT, E2609, A BACE INHIBITOR: RESULTS FROM A PHASE‐2 STUDY IN SUBJECTS WITH MILD COGNITIVE IMPAIRMENT AND MILD‐TO‐MODERATE DEMENTIA DUE TO ALZHEIMER'S DISEASE
P4‐389: ELENBECESTAT, E2609, A BACE INHIBITOR: RESULTS FROM A PHASE‐2 STUDY IN SUBJECTS WITH MILD COGNITIVE IMPAIRMENT AND MILD‐TO‐MODERATE DEMENTIA DUE TO ALZHEIMER'S DISEASE Open
This Phase-2, 18-month, placebo-controlled study investigated the safety of elenbecestat in MCI-to-moderate AD subjects and explored its effects on biomarkers and clinical endpoints. Subjects were diagnosed as AD (NIA-AA 2011 criteria) and…
View article: Long-term effectiveness and safety of once-daily, single-entity, extended-release hydrocodone in patients of ≥75 years of age with moderate to severe nonmalignant and nonneuropathic pain
Long-term effectiveness and safety of once-daily, single-entity, extended-release hydrocodone in patients of ≥75 years of age with moderate to severe nonmalignant and nonneuropathic pain Open
In elderly (≥75 years) individuals, age-associated physiologic changes and a higher prevalence of comorbidities, polypharmacy, and increased susceptibility to medication-induced side effects complicate pain management. Hysingla®…
View article: P3‐018: An Evaluation of the Safety of Nelotanserin, A Highly Potent and Selective 5‐HT2A Inverse Agonist That is Being Developed as a Treatment for Visual Hallucinations and REM Behavior Disorder in Lewy Body Dementia
P3‐018: An Evaluation of the Safety of Nelotanserin, A Highly Potent and Selective 5‐HT2A Inverse Agonist That is Being Developed as a Treatment for Visual Hallucinations and REM Behavior Disorder in Lewy Body Dementia Open
Lewy bodies Dementia (LBD) is a progressive neurodegenerative disease, affecting approximately 1.4 million elderly in the US. It includes two related disorders: dementia with Lewy bodies (DLB) and Parkinson's disease dementia. While cognit…
View article: Efficacy and Safety of Once‐Daily Extended‐Release (<scp>ER</scp>) Hydrocodone in Individuals Previously Receiving <scp>ER</scp> Morphine for Chronic Pain
Efficacy and Safety of Once‐Daily Extended‐Release (<span>ER</span>) Hydrocodone in Individuals Previously Receiving <span>ER</span> Morphine for Chronic Pain Open
Objectives This post hoc analysis examined the effectiveness and safety of hydrocodone bitartrate ( HYD ) in patients with moderate‐to‐severe chronic pain who were previously taking extended‐release morphine (morphine ER ) for pain managem…
View article: Long-term safety and effectiveness of once-daily, single-entity, extended-release hydrocodone over 76 weeks of an open-label study in patients with chronic noncancer and nonneuropathic pain
Long-term safety and effectiveness of once-daily, single-entity, extended-release hydrocodone over 76 weeks of an open-label study in patients with chronic noncancer and nonneuropathic pain Open
HYD was generally well tolerated. No unexpected safety concerns emerged. Pain control was sustained throughout 76 weeks of treatment.
View article: A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain
A multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of single-entity, once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain Open
This multicenter, randomized, double-blind, placebo-controlled study with an enriched enrollment, randomized withdrawal design was conducted to evaluate the analgesic efficacy and safety of single-entity, once-daily hydrocodone 20 to 120 m…
View article: A Subgroup Analysis Found no Diminished Response to Buprenorphine Transdermal System Treatment for Chronic Low Back Pain Patients Classified with Depression
A Subgroup Analysis Found no Diminished Response to Buprenorphine Transdermal System Treatment for Chronic Low Back Pain Patients Classified with Depression Open
Background Chronic pain ( CP ) patients with depression typically exhibit worse post‐treatment outcomes than nondepressed CP patients. The cause is often assumed to reflect a differential response to treatment, neglecting other potential e…
View article: Buprenorphine Transdermal System Improves Sleep Quality and Reduces Sleep Disturbance in Patients with Moderate‐to‐Severe Chronic Low Back Pain: Results from Two Randomized Controlled Trials
Buprenorphine Transdermal System Improves Sleep Quality and Reduces Sleep Disturbance in Patients with Moderate‐to‐Severe Chronic Low Back Pain: Results from Two Randomized Controlled Trials Open
Objective To evaluate the impact of buprenorphine ( B utrans ® ) transdermal S ystem ( BTDS ) treatment on sleep outcomes for patients with moderate‐to‐severe chronic low back pain ( CLBP ). Methods Two enriched‐enrollment, randomized‐with…