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

NCT06942728 | Not Yet Recruiting

• 1 other identifier: 5032
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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

  8 months

Secondary Outcomes (1)

• Evaluation the effects of neurosensory telerehabilitation on visual tests score

  8 months

Study Arms (2)

Sperimental

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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.

Sperimental

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 60 years with a diagnosis of aMCI
• Signing of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, Polo Nazionale Ipovisione

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Simona Turco

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Turco

CONTACT

+390635510819; simona.turco@guest.policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 24, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 24, 2025

Record last verified: 2025-03

Locations

IT (1)