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Background: Controversies exist around the external validity of clinical trials on disease-modifying treatments for Alzheimer's disease (AD). Detailed information on the clinical characteristics of research participants is lacking, hampering the understanding of their representativeness. Objective: This study aimed to systematically review the baseline comorbidities and health status of patients with AD enrolled in clinical trials. Methods: A systematic review of scientific and gray literature was conducted. Randomized controlled trials, enrolling participants in the AD continuum, and testing amyloid- and tau-targeting monoclonal antibodies were selected. Data on the type of study and intervention and the baseline clinical characteristics of participants were extracted. The proportion of studies reporting information on comorbidities, integrative measures of health (e.g., number of chronic diseases and multimorbidity, frailty, and gait speed), and non-neurological concomitant therapies of participants was calculated. Results: Thirty-six articles, referring to 41 studies (21,952 participants) were included. None of the retained trials provided information on the comorbidities or other integrative measures reflecting the baseline health status of participants. Only three studies reported data on non-neurological concomitant therapies. Five documents providing relevant information were identified through gray literature searches covering the websites of regulatory agencies and pharmaceutical manufacturers. Conclusions: The health characteristics of patients with AD included in randomized controlled trials are poorly reported. Therefore, the external validity of the study findings cannot be fully appreciated. [ABSTRACT FROM AUTHOR]

Background: Alzheimer's disease (AD)‐related biomarkers assessed in blood have proved to be useful for detecting dementia and cognitive impairment in the memory clinic. However, less is known about their predictive value in the long‐term and in a community‐based setting. Method: We examined six common serum‐derived biomarkers of AD (P‐tau181, T‐tau, Aβ42/Aβ40 ratio, P‐tau181/Aβ42 ratio, Nfl, and GFAP) from the baseline assessment of the population‐based Swedish National Study on Aging and Care in Kungsholmen (SNAC‐K; n = 2071, mean age at baseline = 72 years). At baseline, participants were free from dementia and neurodegenerative disorders and their cognitive level was within normal range (Mini‐Mental State Examination score > 23). Global cognition and performance in four specific domains (i.e., episodic and semantic memory, verbal fluency, and perceptual speed) were assessed regularly with a neuropsychological test battery across up to 15 years. Associations of AD‐related serum biomarkers with rate of cognitive decline across the follow‐up period were examined with linear mixed‐effects models. Result: Effects on rate of change in all examined cognitive domains were observed for all biomarkers, except T‐tau. The strongest associations were observed for P‐tau181 (global cognition: β = ‐0.024, 95% CI: ‐0.029 to ‐0.020) and for individuals with relatively high biomarker concentrations (3rd or 4th quartile). Interactions were explored for age, sex, and APOE ԑ4‐carrier‐status. Conclusion: To summarize, this study shows that higher concentrations of blood‐based biomarkers for neurodegeneration are associated with faster rates of cognitive decline in the general elderly population. [ABSTRACT FROM AUTHOR]

Background: More than 500,000 dementia cases can be estimated among migrants living in Europe. There is the need to collect "real world" data on the preparedness of healthcare services to support the inclusion of migrants in the public health response to dementia. The present study aimed (i) to estimate the number of migrants referred to Italian memory clinics (Centers for Cognitive Disorders and Dementia [CCDDs]) and (ii) to identify possible barriers and resources for the provision of diversity‐sensitive care. Methods: A survey of all Italian CCDDs was conducted between December 2020 and April 2021. An online questionnaire was developed to obtain information on the number of migrants referred to Italian CCDDs in 2019, the challenges encountered in the diagnostic approach, and possible facilitators in the provision of care. Results: Overall, 343 of the 570 contacted CCDDs completed the survey questionnaire (response rate: 60.2%). Nearly 4527 migrants were referred to these services in 2019. Migrants accounted for a median 1.1% (IQR: 0.9%–2.8%) of overall CCDD referrals. More than one‐third of respondents reported that the number of migrants referred to their facilities had increased in the last 5 years. The overall quality of the migrants' cognitive assessment was deemed to be very poor or insufficient in most cases. A minority of CCDDs had translated information material on dementia and reported the possibility to contact cultural mediators and interpreters. Conclusions: A relevant number of migrants are being referred to Italian CCDDs that are still not adequately prepared to deliver diversity‐sensitive care and support. [ABSTRACT FROM AUTHOR]