Deadline: 10 May 2024
Alzheimer disease and dementia
Dementia is a term for several diseases that affect memory, thinking, and the ability to perform daily activities. Dementia is a major cause of disability and the seventh leading cause of death globally. In 2019, over 55 million people were estimated to be living with dementia, of which 60-70% were caused by Alzheimer disease (AD).
Receiving a timely and accurate AD diagnosis is a prerequisite for accessing services and support for the person, families, and care partners. Currently, a diagnosis of AD is based on clinical judgment, which can be supported by imaging techniques and laboratory analysis of cerebrospinal fluid (CSF). However, there is a global shortage of qualified health professionals and access to imaging and CSF analysis is similarly limited, particularly in low- and middle-income countries (LMICs), where the number of specialized healthcare workforce is significantly lower and health systems’ infrastructure and funding is unable to sustainably provide such services to populations.
Scientific evidence on the use of blood-based biomarkers to support the diagnosis of AD has shown promising advances in recent years. However, , current AD blood tests are being investigated in highly resourced, carefully controlled clinical settings and in populations with limited diversity. The real-world implementation of AD blood tests requires further validation on a larger scale, considering the clinical contexts in which they will be utilized particularly in LMICs.
Biomarker tests are needed to support the diagnosis of AD to benefit people and carers around the world. Such tests are essential to rule-in or rule-out AD and support clinical decision-making.
WHO Preferred Product Characteristics (PPCs) are technical documents that define the preferred attributes of diagnostic products for regulatory purposes, policy, and programmatic implementation. This WHO PPC will be a timely publication to promote the development of diagnostic products using emerging technologies and ensure that these will not only exhibit optimal clinical performance but also be relevant to different populations, affordable and available to those who need it.
The World Health Organization (WHO) is seeking feedback on the draft PPC from experts in the industry, product developers, the scientific community, people with lived experience and clinicians currently involved in the diagnosis and management of AD.
Details of the PPC can be found below (please use the file ‘table for feedback’ to provide your inputs). You are welcome to provide comments as an individual or as a representative of a group:
Preferred product characteristics (Context and background)
Draft Preferred product characteristics (Table for feedback)
Proposed revisions arising from the public consultations will be considered by the PPC working group before it is finalized. The final PPC will guide the development and implementation of blood-based biomarkers for the diagnosis of AD.
If you have any comments, please send them using the ‘table for feedback’ file and use the email subject line AD blood-based biomarkers PPC feedback and submit it to brainhealth@who.int
For more information about dementia, visit: Dementia (who.int)