Epidemiology of fungal infection in COVID 19 in Spain during 2020 and 2021: a nationwide study.

We realize a nationwide population-based retrospective study to analyze the characteristics and risk factors of fungal co-infections in COVID-19 hospitalized patients as well as describe their causative agents in the Spanish population in 2020 and 2021. Data were obtained from records in the Minimum Basic Data Set of the National Surveillance System for Hospital Data in Spain, provided by the Ministry of Health, and annually published with two years lag. The assessment of the risk associated with the development of healthcare-associated fungal co-infections was assessed using an adjusted logistic regression model. The incidence of fungal co-infection in COVID-19 hospitalized patients was 1.41%. The main risk factors associated were surgery, sepsis, age, male gender, obesity, and COPD. Co-infection was associated with worse outcomes including higher in-hospital and in ICU mortality, and higher length of stay. Candida spp. and Aspergillus spp. were the microorganisms more frequent. This is the first study analyzing fungal coinfection at a national level in hospitalized patients with COVID-19 in Spanish population and one of the few studies available that demonstrate that surgery was an independent risk factor of Aspergillosis coinfection in COVID-19 patients.

CTAD Task Force Paper: Neuropsychiatric Symptoms in AD: Clinical Trials Targeting Mild Behavioral Impairment: A Report from the International CTAD Task Force.

The International CTAD Task Force (TF) addressed challenges related to designing clinical trials for agitation in dementia, presenting accomplishments from the two previous TFs on neuropsychiatric symptoms (NPS). In addition, this TF proposed a paradigm shift in NPS assessment and management, presenting Mild Behavioral Impairment (MBI) as a clinical syndrome. MBI is marked by later-life emergent and persistent NPS in dementia-free older persons (ranging from cognitively unimpaired to subjective cognitive decline to mild cognitive impairment), which facilitates earlier detection and better prognostication of Alzheimer's disease (AD). The TF has made the following recommendations for incorporation of NPS into AD preventative trials: (1) clinical trials targeting improvement in MBI symptoms should be undertaken; (2) treatment trials for MBI should be disease specific and confirm the diagnosis of participants using biomarkers; trials should include measures sensitive to cognitive changes in preclinical AD, which can serve as outcome measures, in addition to changes in biomarker levels; (3) as a first step, pharmacotherapeutic trials should address the full MBI complex as well as the specific symptoms/domains that constitute MBI; (4) clinical trials using problem-adaptation psychotherapy to target affective MBI should be considered; and (5) MBI should be considered in AD trials of disease modifying therapies. The well-validated and widely-used MBI Checklist (MBI-C) is an appropriate symptom rating scale for these studies, as it was developed specifically to identify and measure MBI in dementia-free persons. Other scales such as the Neuropsychiatric Inventory (NPI) may be used, although administration at two timepoints may be necessary to operationalize the MBI criterion of symptom persistence.

Espectro de neuromielitis óptica: ¿seropositivo para la anticuaporina es una entidad diferente de los pacientes que son seronegativos? Una perspectiva de Colombia / Neuromyelitis optica spectrum disorder: Do patients positive and negative for anti–aquaporin-4 antibodies present distinct entities? A Colombian perspective

Introducción: La neuromielitis óptica es una enfermedad inflamatoria del sistema nervioso central, caracterizada por ataques de neuritis óptica y mielitis transversa longitudinalmente extensa. El descubrimiento del biomarcador diagnóstico anticuerpo anti-acuaporina-4 y los hallazgos imagenológicos en resonancia magnética cerebral han permitido el reconocimiento de un fenotipo clínico más amplio y detallado denominado espectro neuromielitis óptica. Objetivo: Determinar las características demográficas y clínicas de los pacientes diagnosticados con NMO/NMOSD, de acuerdo con la seropositividad del anticuerpo, en dos instituciones de cuarto nivel de complejidad en Bogotá. Métodos: Se realizó un estudio tipo serie de casos. Fueron incluidos aquellos pacientes > 18 años con diagnóstico de NMO/NMOSD, valorados en el Servicio de Neurología de dos hospitales de alta complejidad entre los años 2013 y 2017, con disponibilidad de estudios imagenológicos y resultados de serología. Se evaluaron variables demográficas, clínicas e imagenológicas, y se realizó un análisis de estas variables, según seropositividad del Ac-AQP4. Resultados: Se incluyeron 35 pacientes con NMO/NMOSD, la mediana de edad de inicio fue de 46,5 años (P25-P75 = 34,2-54,0), la mayoría de los pacientes tuvo manifestaciones clínicas a nivel sensitivo (n = 25) y motor (n = 26), en seis (n = 6) pacientes se identificó una enfermedad autoinmune concomitante. Se encontró seropositividad en 20 pacientes. Encontramos algunas diferencias en las características clínicas e imagenológicas, pero solo la edad y el compromiso de nervio óptico mostraron diferencia estadísticamente significativa (p = 0,03). Conclusiones: No se encontraron grandes diferencias clínicas, imagenológicas y de laboratorio, según la seropositividad del Ac-AQP4, excepto en la edad de inicio y el compromiso de nervio óptico (uni o bilateral), pero deben ser estudiadas de manera más detallada en poblaciones más amplias.(AU)

Introduction: Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system characterised by attacks of optic neuritis and longitudinally extensive transverse myelitis. The discovery of anti–aquaporin-4 (anti-AQP4) antibodies and specific brain MRI findings as diagnostic biomarkers have enabled the recognition of a broader and more detailed clinical phenotype, known as neuromyelitis optica spectrum disorder (NMOSD). Objective: This study aimed to determine the demographic and clinical characteristics of patients with NMO/NMOSD with and without seropositivity for anti-AQP4 antibodies, in 2 quaternary-level hospitals in Bogotá. Methods: Our study included patients > 18 years of age and diagnosed with NMO/NMOSD and for whom imaging and serology results were available, assessed between 2013 and 2017 at the neurology departments of hospitals providing highly complex care. Demographic, clinical, and imaging data were gathered and compared in patients with and without seropositivity for anti-AQP4 antibodies. Results: The sample included 35 patients with NMO/NMOSD; the median age of onset was 46.5 years (P25-P75, 34.2-54.0); most patients had sensory (n = 25) and motor manifestations (n = 26), and a concomitant autoimmune disease was identified in 6. Twenty patients were seropositive for anti-AQP4 antibodies. Only age and presence of optic nerve involvement showed statistically significant differences between groups (p = .03). Conclusions: Clinical, imaging, and laboratory variables showed no major differences between patients with and without anti-AQP4 antibodies, with the exception of age of onset and presence of optic nerve involvement (uni- or bilateral); these factors should be studied in greater detail in larger populations.(AU)

Can We Use Blood Biomarkers as Entry Criteria and for Monitoring Drug Treatment Effects in Clinical Trials? A Report from the EU/US CTAD Task Force.

In randomized clinical trials (RCTs) for Alzheimer's Disease (AD), cerebrospinal fluid (CSF) and positron emission tomography (PET) biomarkers are currently used for the detection and monitoring of AD pathological features. The use of less resource-intensive plasma biomarkers could decrease the burden to study volunteers and limit costs and time for study enrollment. Blood-based markers (BBMs) could thus play an important role in improving the design and the conduct of RCTs on AD. It remains to be determined if the data available on BBMs are strong enough to replace CSF and PET biomarkers as entry criteria and monitoring tools in RCTs.

Performance of first-trimester combined screening for preterm pre-eclampsia: findings from cohort of 10 110 pregnancies in Spain.

OBJECTIVE: To evaluate the diagnostic accuracy of the Fetal Medicine Foundation (FMF) competing-risks model, incorporating maternal characteristics, mean arterial pressure (MAP), uterine artery pulsatility index (UtA-PI) and placental growth factor (PlGF) (the 'triple test'), for the prediction at 11-13 weeks' gestation of preterm pre-eclampsia (PE) in a Spanish population. METHODS: This was a prospective cohort study performed in eight fetal medicine units in five different regions of Spain between September 2017 and December 2019. All pregnant women with a singleton pregnancy and a non-malformed live fetus attending a routine ultrasound examination at 11 + 0 to 13 + 6 weeks' gestation were invited to participate. Maternal demographic characteristics and medical history were recorded and MAP, UtA-PI, serum PlGF and pregnancy-associated plasma protein-A (PAPP-A) were measured following standardized protocols. Treatment with aspirin during pregnancy was also recorded. Raw values of biomarkers were converted into multiples of the median (MoM), and audits were performed periodically to provide regular feedback to operators and laboratories. Patient-specific risks for term and preterm PE were calculated according to the FMF competing-risks model, blinded to pregnancy outcome. The performance of screening for PE, taking into account aspirin use, was assessed by calculating the area under the receiver-operating-characteristics curve (AUC) and detection rate (DR) at a 10% fixed screen-positive rate (SPR). Risk calibration of the model was assessed. RESULTS: The study population comprised 10 110 singleton pregnancies, including 72 (0.7%) that developed preterm PE. In the preterm PE group, compared to those without PE, median MAP MoM and UtA-PI MoM were significantly higher, and median serum PlGF MoM and PAPP-A MoM were significantly lower. In women with PE, the deviation from normal in all biomarkers was inversely related to gestational age at delivery. Screening for preterm PE by a combination of maternal characteristics and medical history with MAP, UtA-PI and PlGF had a DR, at 10% SPR, of 72.7% (95% CI, 62.9-82.6%). An alternative strategy of replacing PlGF with PAPP-A in the triple test was associated with poorer screening performance for preterm PE, giving a DR of 66.5% (95% CI, 55.8-77.2%). The calibration plot showed good agreement between predicted risk and observed incidence of preterm PE, with a slope of 0.983 (95% CI, 0.846-1.120) and an intercept of 0.154 (95% CI, -0.091 to 0.397). CONCLUSIONS: The FMF model is effective in predicting preterm PE in the Spanish population at 11-13 weeks' gestation. This method of screening is feasible to implement in routine clinical practice, but it should be accompanied by a robust audit and monitoring system, in order to maintain high-quality screening. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.

Microplastic ingestion by common terns (Sterna hirundo) and their prey during the non-breeding season.

Current evidence demonstrates the presence and persistence of microplastics in the marine food web. Seabirds are predators in marine ecosystems and are highly exposed to marine plastic debris through the food. The aim of this work was to examine the presence of microplastics in a long-distance migratory seabird, the Common tern (Sterna hirundo) (n = 10), and in their prey (n = 53) during the non-breeding season. The study was conducted in Punta Rasa, Bahía Samborombón, province of Buenos Aires, which is an important resting and feeding location for migratory seabirds and shorebirds in South America. Microplastics were found in all the birds examined. The occurrence of microplastics in the gastrointestinal tract (GIT) of Common terns (n = 82) was higher than in regurgitated prey (RP) (n = 28), which is likely reflecting trophic transfer process. Almost all microplastics found were fibers and only 3 were fragments. Microplastics were sorted by color; transparent, black and blue-colored fibers were the most abundant plastic types. Characterization of the polymer type by Fourier Transform Infrared Spectrometry (FTIR) revealed that cellulose ester plastics, polyethylene terephtalate, polyacrylonitrile and polypropylene were the most abundant types found in both the gastrointestinal tract and prey. Our results highlight the high levels of ingested microplastics in Common terns and in their prey, and reflect a concern in this important location for migratory seabirds.

Herramientas para la evaluación integral de la función sexual en pacientes con esclerosis múltiple / Tools for comprehensive evaluation of sexual function in patients with multiple sclerosis

Introducción: La esclerosis múltiple (EM) es una enfermedad desmielinizante del sistema nervioso central (SNC) que afecta a adultos jóvenes, ocasionando una variedad de síntomas (motores, visuales, control de esfínteres, alteraciones de la marcha) que impactan la funcionalidad del paciente; sin embargo, otros síntomas, como la disfunción sexual (DS), también pueden tener un efecto sobre la calidad de vida.DesarrolloLa DS puede presentarse en cualquier momento del curso de la enfermedad, su prevalencia varía entre 50 y 90%, puede ser secundaria a lesiones desmielinizantes en médula espinal y/o cerebro, ocasionada por síntomas que no incluyen directamente el sistema nervioso —fatiga, aspectos psicológicos, sociales y culturales—. Si bien se ha logrado establecer su prevalencia y su impacto sobre la calidad de vida, la DS todavía es una condición frecuentemente subestimada, razón por la cual en este artículo se revisan las diferentes escalas que ayudan a evaluar la presencia o la severidad de esta para dar un manejo multidisciplinario temprano, según corresponda.ConclusiónCinco cuestionarios han sido evaluados y/o diseñados para pacientes con EM, los cuales podrían identificar la presencia de DS, su etiología y, con esto, determinar posibilidades de tratamiento. La EM debe ser comprendida como una enfermedad compleja que abarca y compromete diferentes aspectos de la salud de los pacientes, y va más allá de solo medir escalas de discapacidad. (AU)

Introduction: Multiple sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that affects young adults, causing a variety of symptoms (motor alterations, visual alterations, loss of sphincter control, gait alterations) that impair the patient's functional status. However, other symptoms, such as sexual dysfunction, can also have an effect on quality of life.DevelopmentSexual dysfunction can occur at any time during the course of the disease; its prevalence varies between 50% and 90%, and it can be secondary to demyelinating lesions in the spinal cord and/or brain or caused by symptoms that do not directly involve the nervous system (fatigue; psychological, social, and cultural factors; etc.). Although its prevalence and impact on quality of life are well known, sexual dysfunction is still frequently underestimated. Therefore, in this article we review the different scales for assessing presence or severity of sexual dysfunction, in order to offer early multidisciplinary management.ConclusionWe evaluated 5 questionnaires that could identify the presence of sexual dysfunction in patients with MS and determine its aetiology, assisting in treatment decision making. MS must be understood as a complex disease that encompasses and compromises different aspects of patients’ health, and goes beyond simply measuring disability. (AU)

Tools for comprehensive evaluation of sexual function in patients with multiple sclerosis.

INTRODUCTION: Multiple sclerosis (MS) is a demyelinating disease of the central nervous system (CNS) that affects young adults, causing a variety of symptoms (motor alterations, visual alterations, loss of sphincter control, gait alterations) that impair the patient's functional status. However, other symptoms, such as sexual dysfunction, can also have an effect on quality of life. DEVELOPMENT: Sexual dysfunction can occur at any time during the course of the disease; its prevalence varies between 50% and 90%, and it can be secondary to demyelinating lesions in the spinal cord and/or brain or caused by symptoms that do not directly involve the nervous system (fatigue; psychological, social, and cultural factors; etc.). Although its prevalence and impact on quality of life are well known, sexual dysfunction is still frequently underestimated. Therefore, in this article we review the different scales for assessing presence or severity of sexual dysfunction, in order to offer early multidisciplinary management. CONCLUSION: We evaluated 5 questionnaires that could identify the presence of sexual dysfunction in patients with MS and determine its aetiology, assisting in treatment decision making. MS must be understood as a complex disease that encompasses and compromises different aspects of patients' health, and goes beyond simply measuring disability.

Neuromyelitis optica spectrum disorder: do patients positive and negative for anti-aquaporin-4 antibodies present distinct entities? A Colombian perspective.

INTRODUCTION: Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system characterised by attacks of optic neuritis and longitudinally extensive transverse myelitis. The discovery of anti-aquaporin-4 (anti-AQP4) antibodies and specific brain MRI findings as diagnostic biomarkers have enabled the recognition of a broader and more detailed clinical phenotype, known as neuromyelitis optica spectrum disorder (NMOSD). OBJECTIVE: This study aimed to determine the demographic and clinical characteristics of patients with NMO/NMOSD with and without seropositivity for anti-AQP4 antibodies, in 2 quaternary-level hospitals in Bogotá. METHODS: Our study included patients > 18 years of age and diagnosed with NMO/NMOSD and for whom imaging and serology results were available, assessed between 2013 and 2017 at the neurology departments of hospitals providing highly complex care. Demographic, clinical, and imaging data were gathered and compared in patients with and without seropositivity for anti-AQP4 antibodies. RESULTS: The sample included 35 patients with NMO/NMOSD; the median age of onset was 46.5 years (P25-P75, 34.2-54.0); most patients had sensory (n = 25) and motor manifestations (n = 26), and a concomitant autoimmune disease was identified in 6. Twenty patients were seropositive for anti-AQP4 antibodies. Only age and presence of optic nerve involvement showed statistically significant differences between groups (P = .03). CONCLUSIONS: Clinical, imaging, and laboratory variables showed no major differences between patients with and without anti-AQP4 antibodies, with the exception of age of onset and presence of optic nerve involvement (uni- or bilateral); these factors should be studied in greater detail in larger populations.

Ganglio centinela en la metástasis ganglionar por cáncer papilar de tiroides: validez diagnóstica y aplicación en la práctica clínica / Sentinel lymph node biopsy in papillary thyroid cancer: Accuracy and application in clinical practice

Introducción La biopsia selectiva del ganglio centinela (BSGC) puede completar el estudio preoperatorio detectando adenopatías no visibles ecográficamente. De este modo, se puede estadificar a los pacientes y estratificar el riesgo de recidiva de forma más precisa y, por tanto, ayudar a definir el tipo de tratamiento tanto quirúrgico como con 131I que debemos realizar. El objetivo fue validar la BSGC para su utilización en el diagnóstico de la metástasis ganglionar por cáncer papilar de tiroides. Métodos Estudio observacional prospectivo de cohortes que incluye a 55 pacientes intervenidos por cáncer papilar de tiroides sin sospecha de afectación ganglionar clínica o radiológica, desde febrero de 2012 hasta febrero de 2015, con un seguimiento de entre 6 y 8 años. Se utilizó 99Tc con nanocoloide intratumoral y una sonda portátil de la gammacámara para la detección de los ganglios centinelas. Variables: edad, género, histológicas, analíticas y estadificación preoperatoria y postoperatoria. Se calculó la sensibilidad, la especificidad y los valores predictivos de la técnica. La validación se determinó calculando la detectabilidad y los falsos negativos de la prueba. Resultados En 53 de los 55 (96,36%) pacientes hubo detección del ganglio centinela. Los falsos negativos fueron 4 (7,5%) pacientes. Del resto, tras aplicar la BSGC, 24 (48,9%) se mantuvieron como N0, 14 (28,5%) pasaron a ser N1a y 11 (22,4%) se clasificaron como N1b. Las diferencias observadas en el estudio fueron significativas (p<0,05). La sensibilidad fue del 86,21%, la especificidad del 100%, el VPP del 100% y el VPN del 85,71%. La precisión diagnóstica fue del 92,45%. Conclusiones La BSGC es una técnica válida para su utilización en los pacientes afectos de cáncer papilar de tiroides, con una alta precisión diagnóstica (AU)

Introduction The presence of lymph nodes metastasis in papillary thyroid cancer modifies the type of surgical resection as well as the indication of the treatment with 131I in the postoperative period. This therapeutic approach is based on the results of the diagnostic tests, like the cervical ultrasonography. Currently other methods of diagnostic are tested as selective sentinel lymph node biopsy (SLNB). It can complement to the ultrasound results. The aim was to validate the SLNB for use in the diagnosis of lymph node metastasis by papillary thyroid cancer. Methods Observational prospective cohort study of 55 patients who underwent papillary thyroid cancer without suspicion of lymph node involvement clinical or radiological, since February 2012 through February 2015, with a follow-up between 6 and 8 years. It was used 99Tc with intratumoral nanocoloid and a portable tube of the gamma camera for the detection of the sentinel node. Variables: age, gender, histological, analytical and preoperative and postoperative staging. The sensitivity, specificity and predictive values of technique was calculated. The validation was determined by calculating the detectability and the false negative results of the test. Results In 53 of the 55 patients (96.36%) there was the sentinel node detection. The false negative were 4 patients (7.5%). Of the rest, after applying the SLNB, 24 (48.9%) were kept as N0, 14 (28.5%) became N1a and 11 (22.4%) were classified as N1b. The differences observed in the study were significant (P<.05). The sensitivity was 86.21%, the specificity of 100%, the PPV was 100% and the NPV of 85.71%. The diagnostic accuracy was 92.45%. Conclusions The SLNB is a valid technique for use in patients suffering from papillary thyroid cancer with a high diagnostic accuracy (AU)

Consensus on the diagnosis and treatment of cow's milk protein allergy of the Latin American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

Cow's milk protein allergy (CMPA) is the most frequent cause of food allergy in the first months of life. Despite the fact that there are different guidelines and recommendations on the management of children with CMPA, there continues to be great variability in diagnostic and therapeutic criteria in Latin America. The Food Allergy Working Group of the Latin American Society for Pediatric Gastroenterology, Hepatology and Nutrition summoned a group of Latin American experts to reach a consensus and formulate a document to unify diagnostic and therapeutic criteria for CMPA. Three teams were formed, each with a coordinator, and the members of each team developed a series of statements for their corresponding module: a) clinical manifestations and diagnosis; b) diagnostic tools, and c) treatment. A search of the medical literature was carried out to support the information presented in each module and 28 statements were then selected. The statements were discussed, after which they were evaluated by all the experts, utilizing the Delphi method. Their opinions on statement agreement or disagreement were anonymously issued. The final statements selected were those with above 75% agreement and their corresponding recommendations were formulated, resulting in the document presented herein.

Unidad multidisciplinar especializada en el tratamiento del pie diabético: evaluación y resultados / Multidisciplinary unit specialized in the treatment of diabetic foot: Evaluation and results

Introducción: En este estudio se realiza la evaluación del proceso asistencial del pie diabético tras la implantación de una vía clínica intrahospitalaria y una consulta multidisciplinar. Objetivos: Evaluar la influencia en factores relacionados con la asistencia, amputaciones y rehabilitación del paciente amputado. Metodología: Estudio retrospectivo en el que se realiza la comparación de tres períodos. Primero (3años): antes de la implantación de la vía. Segundo (5años): posterior a la implantación de la vía. Tercero (10años): posterior a la implantación de la consulta. Resultados: Una consulta especializada en la atención del pie diabético contribuye a una reducción de las amputaciones femorales y menores. Se han optimizado la valoración y el tratamiento por parte de rehabilitación de los pacientes sometidos a amputación mayor. Conclusión: La implantación de vía y consulta contribuye a aumentar la preservación del miembro inferior. Sin embargo, la incidencia sigue siendo alta, sugiriendo que los cuidados del pie diabético permanecen subóptimos.(AU)

Introduction: In this study the evaluation of the care process of the diabetic foot will be carried out after the implementation of an intra-hospital clinical pathway and a multidisciplinary consultation. Objectives: Evaluate the influence on factors related to the care, amputations, and rehabilitation of the amputee patient. Methodology: Retrospective study, in which the comparison of three periods has been made. First (3years): Before the implantation of the pathway. Second (5years): After the implementation of the pathway. Third (10years): After the implementation of the consultation. Results: A specialized consultation in diabetic foot care contributes to a reduction in femoral and minor amputations. The assessment and treatment by rehabilitation of patients undergoing major amputation has been optimized. Conclusion: The implantation of the pathway and consultation contributes to the preservation of the lower limb. However, the incidence remains high, suggesting that diabetic foot care remains suboptimal.(AU)

[Multidisciplinary unit specialized in the treatment of diabetic foot: Evaluation and results]. / Unidad multidisciplinar especializada en el tratamiento del pie diabético: evaluación y resultados.

INTRODUCTION: In this study the evaluation of the care process of the diabetic foot will be carried out after the implementation of an intra-hospital clinical pathway and a multidisciplinary consultation. OBJECTIVES: Evaluate the influence on factors related to the care, amputations, and rehabilitation of the amputee patient. METHODOLOGY: Retrospective study, in which the comparison of three periods has been made. First (3years): Before the implantation of the pathway. Second (5years): After the implementation of the pathway. Third (10years): After the implementation of the consultation. RESULTS: A specialized consultation in diabetic foot care contributes to a reduction in femoral and minor amputations. The assessment and treatment by rehabilitation of patients undergoing major amputation has been optimized. CONCLUSION: The implantation of the pathway and consultation contributes to the preservation of the lower limb. However, the incidence remains high, suggesting that diabetic foot care remains suboptimal.

Using Digital Tools to Advance Alzheimer's Drug Trials During a Pandemic: The EU/US CTAD Task Force.

The 2020 COVID-19 pandemic has disrupted Alzheimer's disease (AD) clinical studies worldwide. Digital technologies may help minimize disruptions by enabling remote assessment of subtle cognitive and functional changes over the course of the disease. The EU/US Clinical Trials in Alzheimer's Disease (CTAD) Task Force met virtually in November 2020 to explore the opportunities and challenges associated with the use of digital technologies in AD clinical research. While recognizing the potential of digital tools to accelerate clinical trials, improve the engagement of diverse populations, capture clinically meaningful data, and lower costs, questions remain regarding the stability, validity, generalizability, and reproducibility of digital data. Substantial concerns also exist regarding regulatory acceptance and privacy. Nonetheless, the Task Force supported further exploration of digital technologies through collaboration and data sharing, noting the need for standardization of digital readouts. They also concluded that while it may be premature to employ remote assessments for trials of novel experimental medications, remote studies of non-invasive, multi-domain approaches may be feasible at this time.

Platform Trials to Expedite Drug Development in Alzheimer's Disease: A Report from the EU/US CTAD Task Force.

A diverse range of platforms has been established to increase the efficiency and speed of clinical trials for Alzheimer's disease (AD). These platforms enable parallel assessment of multiple therapeutics, treatment regimens, or participant groups; use uniform protocols and outcome measures; and may allow treatment arms to be added or dropped based on interim analyses of outcomes. The EU/US CTAD Task Force discussed the lessons learned from the Dominantly Inherited Alzheimer's Network Trials Unit (DIAN-TU) platform trial and the challenges addressed by other platform trials that have launched or are in the planning stages. The landscape of clinical trial platforms in the AD space includes those testing experimental therapies such as DIAN-TU, platforms designed to test multidomain interventions, and those designed to streamline trial recruitment by building trial-ready cohorts. The heterogeneity of the AD patient population, AD drugs, treatment regimens, and analytical methods complicates the design and execution of platform trials, yet Task Force members concluded that platform trials are essential to advance the search for effective AD treatments, including combination therapies.