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NCT Number: NCT06942728

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

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.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, Polo Nazionale Ipovisione

Rome, Lazio, 00168, Italy

Location contact

Simona Turco

CONTACT

[email protected]

+390635510819

Simona Turco

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nLIFE EyeFitness

Device

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.

Primary outcomes

  1. The effects of neurosensory telerehabilitation in elderly subjects with MCI

    Time frame: 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

Secondary outcomes

  1. Evaluation the effects of neurosensory telerehabilitation on visual tests score

    Time frame: 8 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Simona Turco

CONTACT

[email protected]

+390635510819

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: Eye-MCI

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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