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

Personalized Medicine in the Elderly With Vision Impairment and Mild Cognitive Impairment: Effects of Sensorineural Telerahabilitation

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06942728
Acronym
Eye-MCI
Enrollment
24
Registered
2025-04-24
Start date
2025-05-01
Completion date
2027-02-28
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Brief 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.

Interventions

DEVICEnLIFE 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.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
The effects of neurosensory telerehabilitation in elderly subjects with MCI8 monthsEvaluate 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

Secondary

MeasureTime frameDescription
Evaluation the effects of neurosensory telerehabilitation on visual tests score8 monthsEvaluate 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.

Countries

Italy

Contacts

Primary ContactSimona Turco
simona.turco@guest.policlinicogemelli.it+390635510819

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026