Personalized Medicine in the Elderly With Vision Impairment and Mild Cognitive Impairment (Eye-MCI)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Mild Cognitive Impairment

Treatments: Device: nLIFE EyeFitness

Study type: Interventional

Funder types: Other

Identifiers

NCT06942728

5032

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Sperimental

Experimental group

Description:

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.

Treatment:

Device: nLIFE EyeFitness

Control

No Intervention group

Description:

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