Development of an Ensemble Learning-based, Multi-dimensional Sensory Impairment Score to Predict Cognitive Impairment in an Elderly Cohort of Southern Italy
Launched by AZIENDA SANITARIA LOCALE BARI · Jan 14, 2025
Trial Information
Current as of July 21, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is focused on understanding how sensory impairments, such as problems with hearing, vision, or even taste and smell, might relate to cognitive impairment in older adults. Researchers believe that losing one or more senses could be linked to a decline in thinking abilities, which may lead to conditions like dementia. The study aims to create a new scoring system that combines various sensory evaluations and lifestyle factors to help predict different types of dementia in older adults, especially those who may already show early signs of cognitive issues.
To participate, individuals must be at least 65 years old and can fall into one of three groups: those with mild cognitive impairment (MCI), those diagnosed with dementia, or healthy older adults with no cognitive issues. Participants will undergo comprehensive tests to evaluate their sensory and cognitive functions. The study is set to begin soon, and it aims to provide valuable insights into how sensory health affects cognitive abilities, potentially leading to better care and support for older adults at risk of dementia.
Gender
ALL
Eligibility criteria
- • Cases: The cases included will be on two different stages of cognitive impairment: MCI and dementia.
- • The inclusion criteria for the MCI cases group will be: 1) to be at least 65 years old at the moment of enrollment: 2) to have an MCI (Montreal Cognitive Assessment, MOCA test, between 15.5-26) 3) to have a complete examination of the clinical, neuropsychological and sensory evaluations. The exclusion criteria for the case group will be 1) do not have the mental capacity to express consent at the follow-up; 2) have developed major malignancies or undergo major therapies could cause a loss in sensory function or cognitive decline; 3) be diagnosed with depression. The total number of MCI cases will be 45.
- • The inclusion criteria for the dementia cases group will be: 1) to be at least 65 years old at the moment of enrollment: 2) to have a mild to moderate cognitive impairment (Montreal Cognitive Assessment, MOCA test, below 15.5) to have a complete examination of the clinical, neuropsychological and sensory evaluations. The exclusion criteria for the case group will be 1) do not have the mental capacity to express consent at the follow-up; 2) have developed major malignancies or undergo major therapies could cause a loss in sensory function or cognitive impairment; 3) be diagnosed with depression. The total number of dementia cases will be 22 (among all the study sites).
- • Control Cohort: The inclusion criteria for the control cohort group will be: 1) to be at least 65 years old at the moment of enrollment: 2) to have a complete examination of the clinical, neuropsychological and sensory evaluations 3) to have no cognitive impairment (measured using MOCA greater 26). The total number of controls will be at least 151 (considering 1:5 allocation).
About Azienda Sanitaria Locale Bari
Azienda Sanitaria Locale Bari (ASL Bari) is a regional health authority in Italy dedicated to improving public health and healthcare services within the Bari province. As a clinical trial sponsor, ASL Bari is committed to advancing medical research and innovation by facilitating and overseeing clinical studies that aim to evaluate new treatments, therapies, and medical technologies. With a focus on patient safety and ethical standards, ASL Bari collaborates with healthcare professionals, researchers, and institutions to ensure the successful implementation and management of clinical trials that address pressing health needs in the community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported