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

NCT ID: NCT06942728

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sperimental

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.

Group Type: EXPERIMENTAL

nLIFE EyeFitness

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simona Turco

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS, Polo Nazionale Ipovisione

Rome, Lazio, Italy

Countries

Italy

Central Contacts

Simona Turco

Role: CONTACT

simona.turco@guest.policlinicogemelli.it

+390635510819

Facility Contacts

Simona Turco

Role: primary

simona.turco@guest.policlinicogemelli.it

+390635510819

Other Identifiers

5032

Identifier Type: -

Identifier Source: org_study_id