Alzheimer’s disease (AD) is the most common dementia in the industrialized world, with prevalence rates well over 30% in the over 80-years-old population. The dementia causes enormous costs to the social healthcare systems, as well as personal tragedies for the patients, families and caregivers. AD is strongly associated with Amyloid-beta (Aβ) protein aggregation, which results in extracellular plaques in the brain, and according to the amyloid cascade hypothesis appeared to be a promising target for the development of AD therapeutics. Within the past decade convincing data has arisen positioning the soluble prefibrillar Aβ-aggregates as the prime toxic agents in AD. However, different Aβ aggregate species are described but their remarkable metastability hampers the identification of a target species for immunization. Passive immunotherapy with monoclonal antibodies (mAbs) against Aβ is in late clinical development but recently the two most advanced mAbs, Bapineuzumab and Solanezumab, targeting an N-terminal or central epitope, respectively, failed to meet their target of improving or stabilizing cognition and function. Preliminary data from off-label treatment of a small cohort for 3 years with intravenous polyclonal immunoglobulins (IVIG) that appear to target different conformational epitopes indicate a cognitive stabilization. Thus, it might be the more promising strategy reducing the whole spectrum of Aβ-aggregates than to focus on a single aggregate species for immunization.

/pdf/passive-anti-amyloid-immunotherapy-in-alzheimer-s-disease-41nqb07ki1.pdf

Passive anti-amyloid immunotherapy in Alzheimer's disease: What are the most promising targets?

Plasma exchange for Alzheimer's disease Management by Albumin Replacement (AMBAR) trial: Study design and progress.

Introduction There is a growing interest in new therapeutic strategies for the treatment of Alzheimer disease (AD) which focus on reducing the beta-amyloid peptide (Aβ) burden in the brain by sequestering plasma Aβ, a large proportion of which is bound to albumin and other proteins. This review discusses the concepts of interaction between Aβ and albumin that have given rise to AMBAR (Alzheimer's Disease Management by Albumin Replacement) project, a new multicentre, randomised, controlled clinical trial for the treatment of AD. Development Results from preliminary research suggest that Albutein® (therapeutic albumin, Grifols) contains no quantifiable levels of Aβ. Studies also show that Albutein® has Aβ binding capacity. On the other hand, AD entails a high level of nitro-oxidative stress associated with fibrillar aggregates of Aβ that can induce albumin modification, thus affecting its biological functions. Results from the phase ii study confirm that using therapeutic apheresis to replace endogenous albumin with Albutein® 5% is feasible and safe in patients with AD. This process resulted in mobilisation of Aβ and cognitive improvement in treated patients. The AMBAR study will test combination therapy with therapeutic apheresis and haemopheresis with the possible leverage effect of Albutein® with intravenous immunoglobulin replacement (Flebogamma® DIF). Cognitive, functional, and behavioural changes in patients with mild to moderate AD will be assessed. Conclusions The AMBAR study represents a new therapeutic perspective for AD.

Treatment of Alzheimer disease using combination therapy with plasma exchange and haemapheresis with albumin and intravenous immunoglobulin: Rationale and treatment approach of the AMBAR (Alzheimer Management By Albumin Replacement) study.

Resumen Introduccion Existe un creciente interes en las nuevas estrategias terapeuticas para la enfermedad de Alzheimer (EA) orientadas a reducir la carga de peptido β-amiloide (Aβ) en el cerebro mediante el secuestro de Aβ en el plasma, un alto porcentaje del cual se encuentra unido a albumina y otras proteinas plasmaticas. En esta revision, se analizan los conceptos de interaccion entre Aβ y albumina que han conducido al desarrollo del proyecto AMBAR (Alzheimer Management By Albumin Replacement) , un nuevo estudio clinico multicentrico, aleatorizado y controlado para el tratamiento de la EA. Desarrollo Resultados de estudios de investigacion basica indican que Albutein ® (albumina terapeutica, Grifols) contiene niveles no cuantificables de Aβ. Asimismo demuestran la capacidad de Albutein ® de unirse a Aβ. Por otro lado, en la EA existe un elevado estres nitro-oxidativo asociado a los agregados fibrilares de Aβ que puede inducir la modificacion de la albumina, afectando a sus funciones biologicas. Resultados del estudio en fase ii confirman que el reemplazo de la albumina endogena con Albutein ® 5% mediante aferesis terapeutica es factible y seguro en pacientes con EA, produciendo una movilizacion de Aβ, ademas de una mejoria cognitiva de los pacientes tratados. En el estudio AMBAR se ensayara el uso combinado de aferesis terapeutica y hemoferesis con el posible efecto potenciador de Albutein ® con reposicion de inmunoglobulina por via intravenosa (Flebogamma ® DIF). Se evaluaran los cambios cognitivos, funcionales y conductuales en pacientes con EA leve o moderada. Conclusiones El estudio AMBAR representa una nueva perspectiva terapeutica ante la EA.

Tratamiento de la enfermedad de Alzheimer mediante terapia combinada de aféresis terapéutica y hemoféresis con albúmina e inmunoglobulina intravenosa: fundamentos y aproximación terapéutica al estudio AMBAR (Alzheimer Management By Albumin Replacement)

Resumen Introduccion La asistencia telefonica a demanda (ATAD) es una practica habitual en las consultas de Neurologia; no obstante, los estudios que valoran dicha modalidad de asistencia sanitaria son escasos. Hemos evaluado la ATAD en cuidadores de pacientes con enfermedad de Alzheimer (EA) desde el punto de vista economico y de la satisfaccion percibida por el cuidador principal. Pacientes y metodos Se selecciono a 97 pacientes con diagnostico de EA segun criterios NINCDS-ADRDA y sus respectivos 97 cuidadores principales. Estudiamos los gastos diferenciales entre las modalidades asistenciales presencial y a demanda a lo largo de 12 meses. A los 12 meses se valoro la satisfaccion de los cuidadores principales mediante un cuestionario autoadministrado. Resultados El ahorro que supuso la ATAD frente la asistencia presencial fue de 80,05 ± 27,07 euros por usuario. Al 73,6% de los cuidadores que usaron la ATAD les parece mejor o mucho mejor esta que la asistencia presencial, mientras que al 2,6% de los cuidadores les parece peor o mucho peor. Conclusiones La ATAD supone un servicio de salud eficiente en el seguimiento de los usuarios con EA en las consultas de Neurologia y la satisfaccion de los usuarios fue alta, por lo que consideramos que deberia incluirse en la cartera de servicios del sistema sanitario.

Evaluación de la asistencia telefónica a demanda en cuidadores de pacientes con enfermedad de Alzheimer

La enfermedad de Alzheimer y otras demencias y su tratamiento integral

Peripheral amyloid-beta mobilization with the intravenous immunoglobulin Flebogamma DIF® in Alzheimer's disease patients

This chapter describes the current situation regarding sex and gender considerations in clinical trials from preclinical research in animal models to large efficacy trials. Despite women comprise two-thirds of the AD population, for several reasons discussed in this chapter such as eligibility criteria or sociocultural factors, women are underrepresented in clinical trials. We provide a set of recommendations that should help revert this situation.

Sex and gender considerations in clinical trials for Alzheimer’s disease: Current state and recommendations

Exploratory analysis of seven confirmed risk factors for Alzheimer's disease with disease progression

Identification of misdiagnosed frontotemporal dementia using apolioprotein genotype and linear discriminant analysis

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