Mild Cognitive ImpairmentEye-MCINCT06942728
Personalized Medicine in the Elderly With Vision Impairment and Mild Cognitive Impairment
A study testing nLIFE EyeFitness in people with Mild Cognitive Impairment, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- nLIFE EyeFitness
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 60 years with a diagnosis of aMCI
- Signing of informed consent
Who cannot join
- Age <60 years
- History of dementia
- Diabetes mellitus
- Uncontrolled hypertension
- Diagnosis of major depression
- Glaucoma
Show all 9Show fewer
- Age-related macular degeneration
- Media opacity and vitreoretinal pathologies that may preclude a correct evaluation
- • Failure to obtain informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS, Polo Nazionale Ipovisione
Rome, Lazio, 00168
Simona Turco, +390635510819, simona.turco@guest.policlinicogemelli.it
Simona Turco
About this study
Official title: Personalized Medicine in the Elderly With Vision Impairment and Mild Cognitive Impairment: Effects of Sensorineural Telerahabilitation
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
- Being tested
- nLIFE EyeFitness
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nLIFE EyeFitnessDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 months
Secondary outcomes (1)
Evaluation the effects of neurosensory telerehabilitation on visual tests score
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simona Turco, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942728
- Sponsor's protocol ID
- 5032
- Acronym
- Eye-MCI
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Medicine in the Elderly With Vision Impairment and Mild Cognitive Impairment: Effects of Sensorineural Telerahabilitation
- ClinicalTrials.gov ID
- NCT06942728
- Acronym / sponsor ID
- Eye-MCI / 5032
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sperimental | Experimental | Device: nLIFE EyeFitnessAll 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. |
| 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 |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥ 60 years with a diagnosis of aMCI
- Signing of informed consent
Key exclusion criteria (9 listed)
- Age <60 years
- History of dementia
- Diabetes mellitus
- Uncontrolled hypertension
- Diagnosis of major depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nLIFE EyeFitnessA 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. | Device | Sperimental |
Primary outcome
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
1 secondary outcome
Evaluation the effects of neurosensory telerehabilitation on visual tests score
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simona Turco principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nLIFE EyeFitness in people with Mild Cognitive Impairment, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simona Turco (+390635510819, simona.turco@guest.policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of neurosensory telerehabilitation in elderly subjects with MCI (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.