Sviluppo di Uno Score di Rischio Multidimensionale Basato Sui Deficit Sensoriali, Con un Approccio in Ensemble Learning, Per il Deterioramento Cognitivo in Una Coorte di Anziani Dell'Italia Meridionale
Trial ID: NCT06783010
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-06-30
Completion date: 2026-01-10
Sponsor: Azienda Sanitaria Locale Bari
Collaborators: Istituti Clinici Scientifici Maugeri SpA; IRCCS De Bellis, Castellana
Conditions: Sensory Impairments; Cognitive Impairment; Artificial Intelligence
Enrollment: 30
Age range: 65 Years - None
Sex: ALL

Summary:
There is now strong scientific literature showing a relationship between sensory loss and cognitive performance and between sensory loss and incident dementia. We take as our starting point that people with hearing, vision, and/or cognitive problems have poorer health outcomes, possibly due to due to common age-related mechanism(s), iatrogenic problems in the health care system (e.g., misdiagnosis), and/or the decay of social networks. With this evidence, our project will provide a better understanding of the relationship between sensory loss and cognitive loss in older adults with or at risk for dementia using objective technologies to measure sensory deficits that refer not only to vision loss, hearing loss, olfaction and taste but also to senses deemed atypical, i.e., nociception. In particular, the project aims:

1. To assess the specific association between different sensory measures (central and peripheral hearing loss, retinal abnormalities measured by OCT, smell and taste objective measures, chronic pain, and proprioception subjective and electrophysiological measures.
2. To develop a multi-dimensional score using sensory features and clinical and lifestyle variables to predict the different types of dementia (Alzheimer's Disease, Fronto-Temporal Dementia, and Vascular Dementia) at different stages (Mild Cognitive impairment and Normal Cognition).
3. To create a connectomic map of the MRI morphologic and dynamic features of the Dementia cases and their relationships with sensorial features, describing the patterns differences in respect to the normal cognition controls.

To achieve the proposed aims, the synergic work of the four units involved in the proposal will be required. Subject assessment will be divided between clinical setting (ICS Maugeri) and population setting (ASL BARI). IRCCS "S. De Bellis" will provide expertise for both design refinement, creation and monitoring of deliverables and milestones, and technological support for sense measurements. Finally, the features extracted in clinical populations afferent to the centers of the Azienda Sanitaria Locale di Bari and the neurological clinics of the ICS Maugeri will be analyzed with innovative methods by the Polytechnic University of Bari using artificial intelligence algorithms based on ensemble learning for the creation of a predictive score for cognitive impairment that takes into account both sensory and clinical aspects and related to lifestyles.

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).

Outcomes:
cognitive decline