Three Novel Patient-Reported Outcome Measures to Assess the Patient Experience With Daily and Weekly HIV Oral Antiretroviral Therapy.

Background: Patient-reported outcome measures (PROMs) can provide data on the barriers and facilitators of adherence to daily oral antiretroviral therapy (OART) regimens. We aimed to develop PROMs to understand the perspectives of people with HIV (PWH) on (1) facilitators/barriers to daily OART regimen adherence and (2) a hypothetical switch to a long-acting (LA)-OART regimen.

Methods: Following the US food and drug administration patient-reported outcome guidance, targeted literature reviews and concept elicitation interviews with clinicians (n = 7) and PWH (n = 28) were conducted to develop conceptual models (CMs) of facilitators/barriers to OART regimen adherence.

Exploring the Content Validity of the Unified Wilson Disease Rating Scale: Insights from Qualitative Research.

Introduction: Wilson disease (WD) is a rare metabolic disorder of impaired copper transport manifesting in hepatic, neurological, and psychiatric symptoms. To evaluate the clinical symptoms of WD in clinical trials, a group of clinicians created the Unified Wilson Disease Rating Scale (UWDRS). Content validity of this scale has not been established.

Innovative Technologies in CNS Trials: Promises and Pitfalls for Recruitment, Retention, and Representativeness.

Objective: Recruitment of a sufficiently large and representative patient sample and its retention during central nervous system (CNS) trials presents major challenges for study sponsors. Technological advances are reshaping clinical trial operations to meet these challenges, and the COVID-19 pandemic further accelerated this development.

Method Of Research: The International Society for CNS Clinical Trials and Methodology (ISCTM; www.

Experience of Daily Life with Generalized Myasthenia Gravis: A Qualitative Investigation and Assessment of Instrument Content Validity.

Introduction: Generalized myasthenia gravis (gMG) is a rare autoimmune disease. Symptoms of gMG are diverse, and understanding of their impact on patients is limited. This qualitative study aimed to provide an in-depth exploration of patients' daily experiences of gMG.

Using qualitative interviews to identify patient-reported clinical trial endpoints and analyses that are the most meaningful to patients with advanced breast cancer.

Background: Designing clinical trials with the emphasis on the patient-centered approach and focusing on clinical outcomes that are meaningful to patients is viewed as a priority by drug developers, regulatory agencies, payers, clinicians, and patients. This study aimed to capture information on clinical trial endpoints that would be most important and relevant for patients with advanced breast cancer, based on patient-reported outcomes.

Methods: Patients with either advanced triple-negative breast cancer [TNBC] and a maximum of two lines of systemic therapy or hormone receptor-positive/human epidermal growth factor receptor 2-negative [HR+/HER2-] breast cancer and a maximum of three lines of systemic therapy, participated in semi-structured concept elicitation interviews.

The patient experience of Wilson disease: a conceptual model based on qualitative research.

Background: Wilson disease (WD) is a rare disease wherein copper accumulates in tissues, leading to hepatic degeneration, neurological impairments, and psychiatric symptoms. This study aimed to characterize the patient experience of WD and develop a conceptual model containing key symptoms and impacts of the disease.

Results: A targeted literature review was conducted to develop a preliminary conceptual model of WD that was subsequently refined through one-on-one interviews with 3 WD clinicians and finalized following concept elicitation interviews with 11 patients and 1 caregiver.

Effects of a combined transcranial magnetic stimulation (TMS) and cognitive training intervention in patients with Alzheimer's disease.

Introduction: This clinical trial evaluates the efficacy and safety of a 6-week course of daily neuroAD™ therapy.

Methods: 131 subjects between 60 and 90 years old, unmedicated for Alzheimer's disease (AD), or on stable doses of an acetylcholinesterase inhibitor and/or memantine, with Mini-Mental State Examination scores between 18 and 26, clinical dementia rating scale scores of 1 or 2, enrolled for a prospective, randomized, double-blind, sham-controlled, multicenter clinical trial. Structural brain MRIs were obtained for transcranial magnetic stimulation targeting.

Tracking early decline in cognitive function in older individuals at risk for Alzheimer disease dementia: the Alzheimer's Disease Cooperative Study Cognitive Function Instrument.

Importance: Several large-scale Alzheimer disease (AD) secondary prevention trials have begun to target individuals at the preclinical stage. The success of these trials depends on validated outcome measures that are sensitive to early clinical progression in individuals who are initially asymptomatic.

Objective: To investigate the utility of the Cognitive Function Instrument (CFI) to track early changes in cognitive function in older individuals without clinical impairment at baseline.

Rivastigmine in moderately severe-to-severe Alzheimer's disease: Severe Impairment Battery factor analysis.

Introduction: The Severe Impairment Battery (SIB) is validated for assessing cognition in patients with severe dementia. The current analysis aimed to further investigate the cognitive efficacy of rivastigmine capsules, as assessed by SIB factor scores, in patients with moderately severe-to-severe Alzheimer's disease (AD).

Methods: This was a retrospective analysis of a 26-week, multicenter, randomized, double-blind, placebo-controlled study of oral rivastigmine conducted in Spain.

Modern chronic traumatic encephalopathy in retired athletes: what is the evidence?

It has been theorized that a career in contact sports may be associated with long-term neurodegenerative changes. This idea dates as far back as the 1920s, was initially reported in boxers, colloquially termed 'punch drunk,' later more formally termed dementia pugilistica (DP), and now coined chronic traumatic encephalopathy (CTE). Despite considerable ongoing interest on this topic, there is so far only limited evidence showing an association between sport-related concussion (SRC) and increased risk for late-life cognitive and neuropsychiatric impairment, with no causality or risk factors yet determined.

UPDATE ON DEMENTIA WITH LEWY BODIES.

Dementia with Lewy bodies (DLB) is the second most common form of dementia after Alzheimer disease (AD). DLB is characterized pathologically by Lewy body and Lewy neuritic pathology, often with variable levels of Alzheimer-type pathology. Core clinical features include fluctuating cognition, visual hallucinations, and parkinsonism resulting in greater impairments of quality of life, more caregiver burden, and higher health-related costs compared with AD.

Prevalence and characterization of mild cognitive impairment in retired national football league players.

It has been hypothesized that exposure to repetitive head trauma from contact sports over a long-playing career may eventuate in an increased risk of late-life cognitive impairment. There are currently two competing hypotheses about the possible mechanism underlying such impairment. One is the presence of a unique neurodegenerative disorder known as ‘‘chronic traumatic encephalopathy’’ (CTE).

The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): Utility in detection and characterization of mild cognitive impairment due to Alzheimer's disease.

Current diagnostic criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) require standardized tests that are capable of measuring a range of neurocognitive abilities in healthy elderly individuals and sensitive to detect change over time. There currently is no clearly-established "gold standard" for this purpose. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a widely used neuropsychological test battery for the clinical diagnosis/tracking of dementia also recently incorporated into clinical trials of new investigational medications for AD treatment.

The Repeatable Battery for the Assessment of Neuropsychological Status effort scale.

The measurement of effort is now considered to be an important component of neuropsychological assessment. In addition to stand-alone measures, built-in, or embedded measures of effort have been derived for a limited number of standard neurocognitive tests. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a widely used brief battery, employed as a core diagnostic tool in dementia and as a neurocognitive screening battery or tracking/outcome measure in a variety of other disorders.

Distinguishing Alzheimer's disease from other major forms of dementia.

Alzheimer's disease (AD) is the most common and most studied cause of dementia. Significant advances have been made since the first set of clinical criteria for AD were put forth in 1984 that are now captured in the new criteria for AD published in 2011. Key features include recognition of a broad AD spectrum (from preclinical to mild cognitive impairment to AD dementia) and requirement of AD biomarkers for diagnosis.

Cognitive and behavioral functioning in Coffin-Siris syndrome and epilepsy: a case presentation.

The authors characterized the cognitive, adaptive, and behavioral sequelae of Coffin-Siris (CS) syndrome and epilepsy in a 7.5-year-old child. Little is known about the early neurobehavioral presentation of CS.

Assessing effort during neuropsychological evaluation with the TOMM in children and adolescents with epilepsy.

Effort assessment is of particular importance in pediatric epilepsy where neuropsychological findings may influence treatment decisions, especially if surgical interventions are being considered. The present investigation examines the Test of Memory Malingering (TOMM) in 60 children and adolescents with epilepsy. The overall pass rate for the sample was 90%.

Prospective memory in amnestic mild cognitive impairment.

Individuals with amnestic mild cognitive impairment (aMCI) often complain of difficulty remembering to carry out intended actions, consistent with findings of impaired prospective memory (PM) in this population. In this study, individuals with aMCI (N = 27) performed worse than healthy controls (N = 27) on the Memory for Intentions Screening Test (Raskin, 2004), including on time- and event-based subscales, and recognition of the intentions. The aMCI participants made more errors overall, but the proportion of the various error types did not differ between the two groups.

Subject-performed tasks improve associative learning in amnestic mild cognitive impairment.

Subject-performed tasks (SPTs) may facilitate the deficit in associative learning among individuals with amnestic mild cognitive impairment (aMCI) by inducing episodic integration of object-action associations. To test this hypothesis, we examined free recall and recognition memory following enactment and verbal encoding in healthy elderly controls and individuals with aMCI. Study lists contained either semantically integrated ("Bounce the ball") or crossed object-action commands, in which episodic and semantic associations were placed in opposition ("Pet the compass").