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Development of an Ensemble Learning-based, Multi-dimensional Sensory Impairment Score to Predict Cognitive Impairment in an Elderly Cohort of Southern Italy

30 participantsStarted 2025-06-30

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
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5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
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5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

cognitive decline

Timeframe: 36 months

Trial details

NCT IDNCT06783010

SponsorAzienda Sanitaria Locale Bari

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-30

Contact for this trial

Francesco Panza, MD

3282954840 f_panza@hotmail.com

View on ClinicalTrials.gov More Sensory Impairments trials