An interventional study of nLIFE EyeFitness in Mild Cognitive Impairment, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Other
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 24 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
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Exclusion Criteria:
All patients will undergo: * Standardized battery of tests for the diagnosis of cognitive decline corresponding to the BDM (Battery for Mental Deterioration * Global assessment measure of cognitive status (Minimal Mental State Examination - MMSE) * Complete eye examination * Tonometry * Visual acuity for distance (ETDRS) and near (MNRead) * Reading speed (IrestTEST) * Microperimetry * Psychological evaluation * Patients with visual impairment randomized to receive neurovisual rehabilitation treatment will carry out neurosensory rehabilitation remotely.
Device: nLIFE EyeFitness
All patients will undergo: * Standardized battery of tests for the diagnosis of cognitive decline corresponding to the BDM (Battery for Mental Deterioration * Global assessment measure of cognitive status (Minimal Mental State Examination - MMSE) * Complete eye examination * Tonometry * Visual acuity for distance (ETDRS) and near (MNRead) * Reading speed (IrestTEST) * Microperimetry * Psychological evaluation
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.
The effects of neurosensory telerehabilitation in elderly subjects with MCI
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
Time frame: 8 months
Evaluation the effects of neurosensory telerehabilitation on visual tests score
Evaluate the effects of neurosensory telerehabilitation, in terms of variation in visual test scores, in elderly subjects affected by visual impairment and MCI using the remote neurovisual rehabilitation platform in use at the Polo Nazionale di Ipovisione.
Time frame: 8 months
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS