OPENING OF A MEMORY CLINIC IN THE PROVINCE OF PAVIA: Evaluation of Case-finding Strategies and Care for People With Cognitive Decline and Their Caregivers.

Dementia is currently one of the most urgent challenges that global public health must address, with a significant caregiving burden that deeply impacts families, communities, and healthcare systems. It is a key priority in healthcare and social care planning worldwide, with growing emphasis on early diagnosis and appropriate support throughout the course of the disease. According to the World Health Organization, more than 55 million people globally have been diagnosed with dementia, and this number is expected to rise to 139 million by 2050. In Italy, approximately one million people are affected by dementia, and around 900,000 have MCI, with more than three million people directly or indirectly involved in caregiving. However, in high-income countries, the proportion of diagnosed cases remains relatively low, with estimates suggesting that only 20-50% of documented cases are diagnosed in primary care settings. The province of Pavia has 539,239 inhabitants, with an estimated 11,300 individuals diagnosed with dementia and 9,000 with MCI. Consistent with international literature, the ratio of observed to expected cases of dementia and MCI suggests a significant underestimation. Timely diagnosis of the disease or risk of disease enables the person and their caregivers to make informed choices, plan for the future, and gain access to treatments that can help manage symptoms. Centers for Cognitive Disorders and Dementia (CCDD) are healthcare services that play a critical role in the management of dementia and cognitive disorders. Scientific evidence shows that timely access to a specialized cognitive assessment and diagnostic service can lead to better outcomes for individuals with cognitive decline and their families, and be cost-effective for the healthcare system. An accurate and timely diagnosis, support for individuals with dementia and their families, along with early intervention by a multidisciplinary team of healthcare professionals, can have a positive impact on maintaining functional abilities and delaying cognitive decline and institutionalization.

The overall goal of this study is to assess the social and health impact of various services and actions aimed at individuals with cognitive decline within two projects initiated in Italy, specifically in in the Pavia area located in northern Italy: the "Ricor-Dare: integrated territorial network for dementia" project and the opening of a new Cognitive Disorders and Dementia Center (CCDD) Lomellina by Fondazione Mondino in the city of Vigevano. Specifically, the primary goal of this study is to measure the effects of case-finding strategies for the timely detection of dementia in its prodromal or early stages across three different settings. The secondary aim of this study is to evaluate and monitor the social and care effects of the activities offered within the two projects, aimed at patients, caregivers, healthcare professionals, and the community, through a series of indicators reflecting social and health care. This objective will allow for the evaluation, through a set of indicators, of the impact of these complex social and health care, and social actions both on patients identified through case-finding activities and on patients attending the new CCDD Lomellina in the province of Pavia.

For the primary goal of this study, the investigators will evaluate the impact of different case-finding strategies in identifying patients with MCI or dementia. These strategies will be implemented across three different settings:

1. General Practitioners (GPs) Offices: With their in-depth knowledge of their patients' medical histories, GPs play a crucial role in identifying those at risk of dementia or exhibiting cognitive symptoms. Using tools like the GP Cognitive Assessment of Cognition (GPcog), GPs can detect early signs of cognitive decline and refer patients for further evaluation at a CCDD. As part of the study, two annual conferences will be organized to train GPs on neurodegenerative diseases, dementia risk factors, and the GPcog. Patients scoring at the GPcog below 5 or in the borderline range (5-8) will be referred for a second-level neuropsychological evaluation at the CCDD. Additionally, a neuropsychologist will visit selected GP offices three times a year. During these visits, the neuropsychologist will conduct interviews, assess risk factors using the Lifestyle for BRAin health (LIBRA), and perform cognitive evaluations using the Addenbrooke's Cognitive Examination-III (ACE-III). Patients with below-normal or borderline ACE-III scores will be recommended for further CCDD evaluation. This initiative aims to enhance GPs' awareness of case-finding tools in their routine practice.
2. Information desk of the Dementia Operations Center (COD): The COD information desk offers a free public service aimed at the early management of citizens reporting subjective cognitive disturbances that may indicate prodromal or early-stage dementia. The case-finding strategy at the COD involves enrolling all citizens who independently report subjective cognitive disturbances without a prior diagnosis of cognitive decline. Specifically, a neuropsychologist will conduct an interview to collect demographic and medical history information, as well as dementia risk factors through the LIBRA Index, and carry out a first-level neuropsychological assessment through the ACE-III. Those scoring below the norm or borderline will be recommended for further evaluation at the CCDD.
3. Open Days: The Open Days are territorial initiatives for citizen designed for the early management of reports regarding subjective cognitive disturbances that could indicate prodromal or early-stage dementia. The case-finding strategy for Open Days involves organizing approximately two events per year, aimed at early detection of cognitive disturbances. During the Open Day, a neuropsychologist will conduct an interview to collect demographic and medical history information, as well as risk factors for dementia through the LIBRA Index, and perform a first-level neuropsychological assessment through the ACE-III. Those scoring below the norm or borderline will be recommended for further evaluation at the CCDD.

For the secondary goal of the study, the investigators will assess the experiences of patients and families who access the new CCDD in the province of Pavia, the impact of care pathways on caregivers, and comparing the effectiveness of the new CCDD with existing ones in the region of Lombardia. Below a detailed description of the six secondary outcomes are presented: