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NCT06783010: DEMETRA
Development of an Ensemble Learning-based, Multi-dimensional Sensory Impairment Score to Predict Cognitive Impairment in an Elderly Cohort of Southern Italy
trial in Sensory Impairments in 30 participants. Not yet recruiting.
30 June 2025
Quick facts
| Lead sponsor | Azienda Sanitaria Locale Bari |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 30 June 2025 |
| Primary completion | 30 June 2025 |
| Estimated completion | 10 January 2026 |
Conditions studied
- Sensory Impairments — all drugs for Sensory Impairments →
- Cognitive Impairment — all drugs for Cognitive Impairment →
- Artificial Intelligence — all drugs for Artificial Intelligence →
Sponsor
Azienda Sanitaria Locale Bari
Who can join
65 and older, any sex, with Sensory Impairments or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06783010 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda Sanitaria Locale Bari
- Last refreshed: 20 January 2025
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