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Starting soon Not applicable

Personalized Medicine in the Elderly With Vision Impairment and Mild Cognitive Impairment

NCT06942728 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-05-01
Last updated
2025-04-24

Condition(s) studied

Mild Cognitive Impairment

Investigational drug(s) / intervention(s)

nLIFE EyeFitness

nLIFE EyeFitness: A software called nLIFE EyeFitness, certified as a Class I Medical device, allows to carry out individualized rehabilitation exercises at home, using own PC or tablet, with monitoring by the Center's operators.

Study summary

Globally, approximately 55 million people suffer from dementia, and 60-70% of cases are due to Alzheimer's disease (AD). Increasing scientific evidence highlights that the pathological changes underlying AD and other forms of dementia begin long before the onset of symptoms. Mild cognitive impairment (MCI) is a clinical condition that in people over 65 shows a prevalence ranging from 3% to 22%. The characteristics of MCI are the presence of a subjective memory disorder and a reduced ability to learn new information with normal general cognitive functioning, normal ability to perform daily activities and the absence of other conditions, such as depression, that could justify the memory disorder. Currently, the diagnosis of MCI is based exclusively on clinical evaluation, including neuropsychological tests.

Currently, there are no therapies available to prevent and/or treat dementia and the options for intervention are represented by treatments such as physical exercise and cognitive treatment. These practices refer to the concept of cognitive reserve. Computerized cognitive training (CCT) is characterized by being a personalized intervention, allows multi-domain training and increases the cognitive processes of patients with MCI. The National Low Vision Center has been using a software called nLIFE EyeFitness for several years, certified as a Class I Medical device. It allows you to carry out individualized rehabilitation exercises at home, using your own PC or tablet, with monitoring by the Center's operators. The exercises currently present stimulate attention, short-term visual memory, reaction time, executive function, working memory and, therefore, also appear suitable for stimulating subjects with MCI.

Eligibility

Sex
ALL
Min age
60 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Patients aged ≥ 60 years with a diagnosis of aMCI * Signing of informed consent Exclusion Criteria: * Age \<60 years * History of dementia * Diabetes mellitus * Uncontrolled hypertension * Diagnosis of major depression * Glaucoma * Age-related macular degeneration * Media opacity and vitreoretinal pathologies that may preclude a correct evaluation * • Failure to obtain informed consent

Primary outcome measure(s)

  • The effects of neurosensory telerehabilitation in elderly subjects with MCI — 8 months
    Evaluate the effects of neurosensory telerehabilitation in terms of reduction of cognitive deterioration by evaluating the scores of neuropsychological questionnaires in use in clinical practice after using the remote neurovisual rehabilitation platform in use at the Polo Nazionale di Ipovisione

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS, Polo Nazionale Ipovisione Rome Lazio
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06942728 on ClinicalTrials.gov ↗ ← All trials in Italy