Mild Cognitive Impairment (MCI)EARLY-COGN^3NCT06657274
EARLY-COGN^3 - Smart Digital Solutions for EARLY Treatment of COGnitive Disability: a Neuropsychological, Neurophysiological and Neurobiological Perspective in Chronic Neurological Diseases - PNRR-MCNT2-2023-12377069
A study testing RICORDO-DTx and Home-based unstructured cognitive stimulation in people with Mild Cognitive Impairment (MCI) and Subjective Cognitive Complaints (SCCs), run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 3 sites in Italy.
Trial summary
The increase in life expectancy in recent decades has led to a large number of people living into old age and an increased risk of developing Chronic Neurological Diseases (CNDs) such as neurodegenerative diseases. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Subjective Cognitive Complaints (SCCs), Parkinson Disease
- What is being tested?
- RICORDO-DTx and Home-based unstructured cognitive stimulation
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesItaly
- Study dates
- 9 Dec 2024to 30 Aug 2026
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PD (Hoehn \& Yahr<3); MCI (with CDR scale≤0.5, MMSE ≥24), and SCC (Subjective Cognitive Complaints);
- Montreal Cognitive Assessment (MoCA) corrected score ≥17.36
- Education ≥ 5 years
- Age eligible for the study: 18≤age≤85
- Native Italian speakers
- Absence of marked hearing/visual impairment
Show all 11Show fewer
- All of the subjects will have normal or corrected-to-normal vision.
- Agreement to participate by signing the informed consent form
- Availability of a caregiver/study partner able to support the participant
- No rehabilitation program in place at the time of enrolment or in the last 3 months before enrolment
- Stable drug treatment (last 3 months), if any
Who cannot join
- Presence of any medical or psychiatric illness that could interfere with completing assessments;
- Presence of any medical condition representing a contraindication to TMS.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, IT, 25125
Maria Cotelli, PhD, +390303501457, mcotelli@fatebenefratelli.eu
Rosa Manenti, PhD, +390303501457, rmanenti@fatebenefratelli.eu
- Recruiting
IRCCS Centro Neurolesi Bonino Pulejo
Messina, IT, 98124
Rocco S Calabrò, MD, +3909060128123, roccos.calabro@irccsme.it
Rocco S Calabrò, MD
- Recruiting
Fondazione Don Carlo Gnocchi - ONLUS, Milan
Milan, IT, 20148
Francesca Baglio, MD, +390240308069, fbaglio@dongnocchi.it
Francesca Baglio, MD
About this study
The increase in life expectancy in recent decades has led to a large number of people living into old age and an increased risk of developing Chronic Neurological Diseases (CNDs) such as neurodegenerative diseases. A higher cumulative risk of dementia has been largely demonstrated in Mild Cognitive Impairment (MCI) and Subjective Cognitive Complaints (SCCs) subjects and in Parkinson's Disease (PD) patients, as compared to the general population. These disorders result in an impairment of the individual's abilities to perform daily tasks. As their disease progresses, patients become dependent on medical services and on family support. Given the limited effectiveness of pharmacological treatments, non-pharmacological interventions to prevent and treat cognitive deficits and the associated difficulties with activities of daily living in neurodegenerative disease patients have gained attention in recent years and, among these, cognitive training offers a potential approach for dementia prevention and improvement of cognitive function. A critical aspect of cognitive training programs is that the most promising interventions have involved intensive in-person sessions that are unlikely to be cost-effective or feasible for large-scale implementation. Within the framework of non-pharmacological interventions, the use of technology to assist the person at risk and/or with mild dementia at home and to extend rehabilitation services in the treatment of dementia has gradually gained importance. Telerehabilitation technologies allow to provide services remotely in patients' homes, allowing access to health care to patients living in rural settings or with mobility difficulties. In addition, the telerehabilitation modality offers the advantage of providing rehabilitation within the natural environment of the patient's home, making the treatment more realistic and possibly more generalizable to the person's daily life. The present project proposes to test a home-based asynchronous cognitive telerehabilitation program aimed at enhancing the continuum of care for MCI, SCCs and PD, using technology. The proposed study is a single blind randomized controlled trial (RCT) involving subjects with CNDs randomly assigned to one out of two intervention groups: i) the tele@cognitive group, who will receive at-home cognitive telerehabilitation (tele@cognitive treatment); ii) the Active Control Group (ACG), who will receive at-home unstructured cognitive stimulation. The aim of the project will be threefold: [1] to test the short-term and long-term efficacy of tele@cognitive protocol as compared to an unstructured cognitive at-home rehabilitation in the treatment of a cohort of patients with CNDs; [2] to explore the changes induced by tele@cognitive intervention on biomolecular and neurophysiological markers; [3] to explore potential cognitive, neurobiological and neurophysiological predictors of response to tele@cognitive treatment.
Read the detailed description
60 subjects with MCI, SCC, PD will be recruited from IRCCS Istituto Centro San Giovanni di Dio, Fatebenefratelli, Brescia, Fondazione Don Carlo Gnocchi - ONLUS, Milan and IRCCS Centro Neurolesi Bonino Pulejo, Messina.
Patients will include both male and female subjects affected by CND: PD (Hoehn \& Yahr<3), MCI (with CDR scale≤0.5, MMSE ≥24) and SCC (Subjective Cognitive Complaints).
All patients will undergo treatment sessions of 45 minutes, 3 days a week for 5 weeks:
- 30 subjects will be assigned to the tele@cognitive group that will receive home-based cognitive telerehabilitation activities with an innovative digital solution for remote rehabilitation of cognitive difficulties according to the digital therapy delivery model;
- 30 subjects will be assigned to the Active Control Group (ACG) that will receive home-based unstructured cognitive stimulation.
The two groups will be matched for sex, age, education and performance in the MoCA test.
All study participants will be administered a multidimensional assessment by an experienced neuropsychologist at baseline (T0), at post-treatment assessment (T1, 5 weeks from T0) and at 3-month follow-up (T2). In addition, participation in the research involves blood sampling and application of Transcranial Magnetic Stimulation (TMS) before (T0) and after (T1) treatment.
- Conditions
- Mild Cognitive Impairment (MCI), Subjective Cognitive Complaints (SCCs), Parkinson Disease
- Being tested
- RICORDO-DTx, Home-based unstructured cognitive stimulation
- Medical subject headings
- Cognitive Dysfunction, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RICORDO-DTxDevice
Tele@cognitive treatment group will receive a total of 5 weeks (3 sessions/week, 45 minutes/session) of home-based cognitive rehabilitation activities with an innovative digital solution for remote rehabilitation of cognitive difficulties according to digital therapeutics delivery model. Subjects assigned to the tele@cognitive group can access the app RICORDO-DTx through a tablet showing the prescribed rehabilitation activities to be performed.
Each cognitive exercise is structured into five levels of difficulty that adaptively increase (algorithm on both subject's performance and perceived difficulty). All data about patient progress and adherence will be collected with this digital solution and will be available to evaluate and monitor the results of rehabilitation.
Home-based unstructured cognitive stimulationBehavioural
Subjects assigned to the home-based unstructured cognitive stimulation will be requested to work on detailed activities for the same duration of the tele@cognitive intervention (3 sessions/week, 45 minutes/session). They will receive, from the therapist, an instructions booklet and a participant diary.
| Study group | Role | What they receive |
|---|---|---|
| tele@cognitive treatment | Experimental | The tele@cognitive treatment group will receive a total of 5 weeks (3 sessions/week, 45 minutes/session) of home-based cognitive rehabilitation activities delivered through a digital telerehabilitation platform. Receives: Device: RICORDO-DTx |
| Active Control Group (ACG) | Active comparator | The Active Control Group (ACG), will receive at-home unstructured cognitive stimulation for 5 weeks (3 sessions/week, 45 minutes/session). Receives: Behavioral: Home-based unstructured cognitive stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global cognition as assessed by Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA) is a screening test for global cognitive functioning. It includes tasks involving several cognitive domains: visuospatial, executive function, naming, selective and sustained attention, language, abstraction, memory and orientation (score range min= 0, max= 30, higher score=better outcome).
Measured: Baseline up to 5 weeks and 3 months
Change in long-term episodic verbal memory as assessed by Free and Cued Selective Reminding Test (FCSRT)
Free and Cued Selective Reminding Test (FCSRT) is a measure of long-term episodic verbal memory. It provides five scores: Immediate Free Recall (IFR, spontaneous recall across three trials; score range min= 0, max= 36), Immediate Total Recall (ITR, total recall across three trials; score range min= 0, max= 36), Delayed Free Recall (DFR, score range min= 0, max= 12), Delayed Total Recall (DTR, score range min= 0, max= 12). Higher scores indicate better performance. Finally, the Index of Sensitivity to Cueing (ISC, score range min= 0, max= 1) reflects the difference between the number of items recalled spontaneously and the number of items recalled with the help of cues. A higher ISC indicates a greater sensitivity to cues.
Measured: Baseline up to 5 weeks and 3 months
Secondary outcomes (22)
Change in measure of quality of life as assessed by EQ-5D-5L
EQ-5D-5L is a measure of health status consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has three response levels (no problems, some problems, unable to/extreme problems). In addition, the questionnaire includes a visual analog scale that records the patient's perception of his or her overall health (score range: min= 0, max= 100, higher score=better outcome).
Measured: Baseline up to 5 weeks and 3 months
Change in measure of non-motor experiences of daily living as assessed by MDS-UPDRS scale, part I
MDS-UPDRS scale, part I (only for PD patients) is a measure of non-motor experiences of daily living consisting of a total of 13 questions (score range min= 0, max= 52, higher score= worse outcome).
Measured: Baseline up to 5 weeks and 3 months
Change in measure of motor abilities as assessed by MDS-UPDRS scale, part III
MDS-UPDRS scale, part III (only for PD patients) is a measure of motor abilities consisting of a total of 18 questions with 33 individual items. Each item has a 0-4 rating, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe (score range: min= 0, max= 132, higher score=worse outcome).
Measured: Baseline up to 5 weeks and 3 months
Change in depressive symptoms as assessed by Hamilton Depression Rating Scale (HDRS)
Hamilton Depression Rating Scale (HDRS) is a measure of severity of depressive symptoms consisting of a total of 21 items (score range min= 0, max= 64, higher score=worse outcome).
Measured: Baseline up to 5 weeks and 3 months
Change in anxiety symptoms as assessed by State-Trait Anxiety Inventory (STAI-Y)
The STAI-Y consisting of two 20-item scales providing separate measures of state and trait anxiety (S-Anxiety and T-Anxiety). Each scale has a score range from a minimum of 20 to a maximum of 80 and a higher score on the scale indicates a worse outcome.
Measured: Baseline up to 5 weeks and 3 months
Change in behavior and personality as assessed by Neuropsychiatric Inventory (NPI)
Neuropsychiatric Inventory (NPI) is used for assessing various neuropsychiatric symptoms. The inventory consists of 12 core domains, each reflecting specific neuropsychiatric symptoms. Each symptom is rated for both frequency and severity. (score range min= 0, max= 144, higher score=worse outcome).
Measured: Baseline up to 5 weeks and 3 months
Change in memory complaints as assessed by Everyday Memory Questionnaire (EMQ)
Everyday Memory Questionnaire (EMQ) is a 20-items questionnaire that evaluate the frequency and impact of memory problems in daily life (score range min= 20, max= 180, higher score=worse outcome).
Measured: Baseline up to 5 weeks and 3 months
Change in non-verbal abstract reasoning as assessed by Raven's Coloured Progressive Matrices
Raven's Coloured Progressive Matrices is a measure of non-verbal abstract reasoning (score range min= 0, max= 36, higher score=better outcome).
Measured: Baseline up to 5 weeks and 3 months
Change in measure of attentional abilities as assessed by Trial Making Test (TMT)
Trial Making Test (TMT, part-A and part-B) is a measure of attentional abilities, visuo-conceptual and visual-motor tracking. TMT-Part A involves visual scanning, number recognition, number sequencing and motor speed. TMT-Part B assesses mental flexibility in managing more than one stimulus at a time and in shifting the course of an ongoing activity. High execution times indicate poor performance (score range: min= n/a, max= no limits).
Measured: Baseline up to 5 weeks and 3 months
Change in measure of executive abilities as assessed by Stroop Test
Stroop Test is a measure of executive abilities, including visual attention, selective attention, cognitive flexibility and inhibitory control of behavior. Two scores are calculated considering the number of errors and the time taken to complete all parts. High execution times and high numbers of errors indicate poor performance.
Measured: Baseline up to 5 weeks and 3 months
Change in measure of constructional praxia as assessed by Rey-Osterrieth Complex Figure-Copy
Rey-Osterrieth Complex Figure-Copy is a measure of constructional praxia (score range min= 0, max= 36, higher score=better outcome).
Measured: Baseline up to 5 weeks and 3 months
Change in measure of fluency abilities as assessed by Verbal Fluency (semantic and phonemic)
Verbal Fluency (semantic and phonemic) is a measure of verbal and semantic fluency abilities, executive functions abilities, lexical store size, lexicon access, and lexical organization (score range min= 0, max= no limits, higher score=better outcome).
Measured: Baseline up to 5 weeks and 3 months
Change in measure of nonverbal long-term memory as assessed by Rey-Osterrieth Complex Figure-Recall
Rey-Osterrieth Complex Figure-Recall is a measure of nonverbal long-term memory (score range min= 0, max= 36, higher score=better outcome).
Measured: Baseline up to 5 weeks and 3 months
Change in NFL and Tau
Neurofilament light chain (NFL) and Tau levels
Measured: Baseline up to 5 weeks
Change in Aß1-40, Aß1-42, p-tau-181; p-tau-231, alpha-synuclein
Aß1-40, Aß1-42, p-tau-181; p-tau-231, alpha-synuclein levels
Measured: Baseline up to 5 weeks
Change in GFAP, chemokines and sTREM2
Glial Fibrillary Acidic Protein (GFAP), chemokines and sTREM2 levels
Measured: Baseline up to 5 weeks
Change in Neurogranin and BDNF
Neurogranin and Brain-Derived Neurotrophic Factor (BDNF) levels
Measured: Baseline up to 5 week
Change in plasma EVs
Size and the concentration of plasma Extracellular Vescicles (EVs)
Measured: Baseline up to 5 weeks
Change in rMT
TMS resting Motor Threshold (rMT)
Measured: Baseline up to 5 weeks
Change in MEPs
TMS Motor Evoked Potentials (MEPs)
Measured: Baseline up to 5 weeks
Change in SICI
TMS Short-interval intracortical inhibition (SICI)
Measured: Baseline up to 5 weeks
Change in SAI
TMS Short-latency afferent inhibition (SAI)
Measured: Baseline up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start9 Dec 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, IRCCS Fondazione Don Carlo Gnocchi, Milano, National Research Council (CNR) - Institute for Biomedical Research and Innovation (IRIB), Messina, IRCCS Centro Neurolesi Bonino Pulejo, Messina
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657274
- Sponsor's protocol ID
- EARLY-COGN^3 - PNRR-MCNT2-2023
- Acronym
- EARLY-COGN^3
- Status last verified
- Apr 2025
- First submitted
- 23 Oct 2024
- Last updated
- 2 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cotelli M, Baglio F, Gobbi E, Campana E, Pagnoni I, Cannarella G, Del Torto A, Rossetto F, Comanducci A, Tartarisco G, Calabro RS, Campisi S, Maione R, Saraceno C, Dognini E, Bellini S, Bortoletto M, Binetti G, Ghidoni R, Manenti R. Smart Digital Solutions for EARLY Treatment of COGNitive Disability (EARLY-COGN;3): A Study Protocol. Brain Sci. 2025 Feb 24;15(3):239. doi: 10.3390/brainsci15030239.
PubMed 40149761
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EARLY-COGN^3 - Smart Digital Solutions for EARLY Treatment of COGnitive Disability: a Neuropsychological, Neurophysiological and Neurobiological Perspective in Chronic Neurological Diseases - PNRR-MCNT2-2023-12377069
- ClinicalTrials.gov ID
- NCT06657274
- Acronym / sponsor ID
- EARLY-COGN^3 / EARLY-COGN^3 - PNRR-MCNT2-2023
- Conditions
- Mild Cognitive Impairment (MCI), Subjective Cognitive Complaints (SCCs), Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Collaborators
- European Union, IRCCS Fondazione Don Carlo Gnocchi, Milano, National Research Council (CNR) - Institute for Biomedical Research and Innovation (IRIB), Messina, IRCCS Centro Neurolesi Bonino Pulejo, Messina
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 24 Oct 2024 (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.
The increase in life expectancy in recent decades has led to a large number of people living into old age and an increased risk of developing Chronic Neurological Diseases (CNDs) such as neurodegenerative diseases. A higher cumulative risk of dementia has been largely demonstrated in Mild Cognitive Impairment (MCI) and Subjective Cognitive Complaints (SCCs) subjects and in Parkinson's Disease (PD) patients, as compared to the general population. These disorders result in an impairment of the individual's abilities to perform daily tasks. As their disease progresses, patients become dependent on medical services and on family support. Given the limited effectiveness of pharmacological treatments, non-pharmacological interventions to prevent and treat cognitive deficits and the associated difficulties with activities of daily living in neurodegenerative disease patients have gained attention in recent years and, among these, cognitive training offers a potential approach for dementia prevention and improvement of cognitive function. A critical aspect of cognitive training programs is that the most promising interventions have involved intensive in-person sessions that are unlikely to be cost-effective or feasible for large-scale implementation. Within the framework of non-pharmacological interventions, the use of technology to assist the person at risk and/or with mild dementia at home and to extend rehabilitation services in the treatment of dementia has gradually gained importance. Telerehabilitation technologies allow to provide services remotely in patients' homes, allowing access to health care to patients living in rural settings or with mobility difficulties. In addition, the telerehabilitation modality offers the advantage of providing rehabilitation within the natural environment of the patient's home, making the treatment more realistic and possibly more generalizable to the person's daily life. The present project proposes to test a home-based asynchronous cognitive telerehabilitation program aimed at enhancing the continuum of care for MCI, SCCs and PD, using technology. The proposed study is a single blind randomized controlled trial (RCT) involving subjects with CNDs randomly assigned to one out of two intervention groups: i) the tele@cognitive group, who will receive at-home cognitive telerehabilitation (tele@cognitive treatment); ii) the Active Control Group (ACG), who will receive at-home unstructured cognitive stimulation. The aim of the project will be threefold: [1] to test the short-term and long-term efficacy of tele@cognitive protocol as compared to an unstructured cognitive at-home rehabilitation in the treatment of a cohort of patients with CNDs; [2] to explore the changes induced by tele@cognitive intervention on biomolecular and neurophysiological markers; [3] to explore potential cognitive, neurobiological and neurophysiological predictors of response to tele@cognitive treatment.
Detailed description
60 subjects with MCI, SCC, PD will be recruited from IRCCS Istituto Centro San Giovanni di Dio, Fatebenefratelli, Brescia, Fondazione Don Carlo Gnocchi - ONLUS, Milan and IRCCS Centro Neurolesi Bonino Pulejo, Messina.
Patients will include both male and female subjects affected by CND: PD (Hoehn \& Yahr<3), MCI (with CDR scale≤0.5, MMSE ≥24) and SCC (Subjective Cognitive Complaints).
All patients will undergo treatment sessions of 45 minutes, 3 days a week for 5 weeks:
- 30 subjects will be assigned to the tele@cognitive group that will receive home-based cognitive telerehabilitation activities with an innovative digital solution for remote rehabilitation of cognitive difficulties according to the digital therapy delivery model;
- 30 subjects will be assigned to the Active Control Group (ACG) that will receive home-based unstructured cognitive stimulation.
The two groups will be matched for sex, age, education and performance in the MoCA test.
All study participants will be administered a multidimensional assessment by an experienced neuropsychologist at baseline (T0), at post-treatment assessment (T1, 5 weeks from T0) and at 3-month follow-up (T2). In addition, participation in the research involves blood sampling and application of Transcranial Magnetic Stimulation (TMS) before (T0) and after (T1) treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tele@cognitive treatment | Experimental | Device: RICORDO-DTxThe tele@cognitive treatment group will receive a total of 5 weeks (3 sessions/week, 45 minutes/session) of home-based cognitive rehabilitation activities delivered through a digital telerehabilitation platform. |
| Active Control Group (ACG) | Active comparator | Behavioral: Home-based unstructured cognitive stimulationThe Active Control Group (ACG), will receive at-home unstructured cognitive stimulation for 5 weeks (3 sessions/week, 45 minutes/session). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of PD (Hoehn \& Yahr<3); MCI (with CDR scale≤0.5, MMSE ≥24), and SCC (Subjective Cognitive Complaints);
- Montreal Cognitive Assessment (MoCA) corrected score ≥17.36
- Education ≥ 5 years
- Age eligible for the study: 18≤age≤85
- Native Italian speakers
Key exclusion criteria (2 listed)
- Presence of any medical or psychiatric illness that could interfere with completing assessments;
- Presence of any medical condition representing a contraindication to TMS.
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 |
|---|---|---|
| RICORDO-DTxTele@cognitive treatment group will receive a total of 5 weeks (3 sessions/week, 45 minutes/session) of home-based cognitive rehabilitation activities with an innovative digital solution for remote rehabilitation of cognitive difficulties according to digital therapeutics delivery model. Subjects assigned to the tele@cognitive group can access the app RICORDO-DTx through a tablet showing the prescribed rehabilitation activities to be performed. Each cognitive exercise is structured into five levels of difficulty that adaptively increase (algorithm on both subject's performance and perceived difficulty). All data about patient progress and adherence will be collected with this digital solution and will be available to evaluate and monitor the results of rehabilitation. | Device | tele@cognitive treatment |
| Home-based unstructured cognitive stimulationSubjects assigned to the home-based unstructured cognitive stimulation will be requested to work on detailed activities for the same duration of the tele@cognitive intervention (3 sessions/week, 45 minutes/session). They will receive, from the therapist, an instructions booklet and a participant diary. | Behavioural | Active Control Group (ACG) |
Primary outcome
Change in global cognition as assessed by Montreal Cognitive Assessment (MoCA)
Time frame: Baseline up to 5 weeks and 3 months
Montreal Cognitive Assessment (MoCA) is a screening test for global cognitive functioning. It includes tasks involving several cognitive domains: visuospatial, executive function, naming, selective and sustained attention, language, abstraction, memory and orientation (score range min= 0, max= 30, higher score=better outcome).
Change in long-term episodic verbal memory as assessed by Free and Cued Selective Reminding Test (FCSRT)
Time frame: Baseline up to 5 weeks and 3 months
Free and Cued Selective Reminding Test (FCSRT) is a measure of long-term episodic verbal memory. It provides five scores: Immediate Free Recall (IFR, spontaneous recall across three trials; score range min= 0, max= 36), Immediate Total Recall (ITR, total recall across three trials; score range min= 0, max= 36), Delayed Free Recall (DFR, score range min= 0, max= 12), Delayed Total Recall (DTR, score range min= 0, max= 12). Higher scores indicate better performance. Finally, the Index of Sensitivity to Cueing (ISC, score range min= 0, max= 1) reflects the difference between the number of items recalled spontaneously and the number of items recalled with the help of cues. A higher ISC indicates a greater sensitivity to cues.
22 secondary outcomes
Change in measure of quality of life as assessed by EQ-5D-5L
Time frame: Baseline up to 5 weeks and 3 months
Change in measure of non-motor experiences of daily living as assessed by MDS-UPDRS scale, part I
Time frame: Baseline up to 5 weeks and 3 months
Change in measure of motor abilities as assessed by MDS-UPDRS scale, part III
Time frame: Baseline up to 5 weeks and 3 months
Change in depressive symptoms as assessed by Hamilton Depression Rating Scale (HDRS)
Time frame: Baseline up to 5 weeks and 3 months
Change in anxiety symptoms as assessed by State-Trait Anxiety Inventory (STAI-Y)
Time frame: Baseline up to 5 weeks and 3 months
Change in behavior and personality as assessed by Neuropsychiatric Inventory (NPI)
Time frame: Baseline up to 5 weeks and 3 months
Change in memory complaints as assessed by Everyday Memory Questionnaire (EMQ)
Time frame: Baseline up to 5 weeks and 3 months
Change in non-verbal abstract reasoning as assessed by Raven's Coloured Progressive Matrices
Time frame: Baseline up to 5 weeks and 3 months
Change in measure of attentional abilities as assessed by Trial Making Test (TMT)
Time frame: Baseline up to 5 weeks and 3 months
Change in measure of executive abilities as assessed by Stroop Test
Time frame: Baseline up to 5 weeks and 3 months
Change in measure of constructional praxia as assessed by Rey-Osterrieth Complex Figure-Copy
Time frame: Baseline up to 5 weeks and 3 months
Change in measure of fluency abilities as assessed by Verbal Fluency (semantic and phonemic)
Time frame: Baseline up to 5 weeks and 3 months
Change in measure of nonverbal long-term memory as assessed by Rey-Osterrieth Complex Figure-Recall
Time frame: Baseline up to 5 weeks and 3 months
Change in NFL and Tau
Time frame: Baseline up to 5 weeks
Change in Aß1-40, Aß1-42, p-tau-181; p-tau-231, alpha-synuclein
Time frame: Baseline up to 5 weeks
Change in GFAP, chemokines and sTREM2
Time frame: Baseline up to 5 weeks
Change in Neurogranin and BDNF
Time frame: Baseline up to 5 week
Change in plasma EVs
Time frame: Baseline up to 5 weeks
Change in rMT
Time frame: Baseline up to 5 weeks
Change in MEPs
Time frame: Baseline up to 5 weeks
Change in SICI
Time frame: Baseline up to 5 weeks
Change in SAI
Time frame: Baseline up to 5 weeks
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 2 May 2025.
- Derived from this study: PubMed 40149761Cotelli M, Baglio F, Gobbi E, Campana E, Pagnoni I, Cannarella G, Del Torto A, Rossetto F, Comanducci A, Tartarisco G, Calabro RS, Campisi S, Maione R, Saraceno C, Dognini E, Bellini S, Bortoletto M, Binetti G, Ghidoni R, Manenti R. Smart Digital Solutions for EARLY Treatment of COGNitive Disability (EARLY-COGN;3): A Study Protocol. Brain Sci. 2025 Feb 24;15(3):239. doi: 10.3390/brainsci15030239.
- Individual participant dataSharing planned: Undecided
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Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RICORDO-DTx and Home-based unstructured cognitive stimulation in people with Mild Cognitive Impairment (MCI) and Subjective Cognitive Complaints (SCCs), run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 3 sites 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 11 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Maria Cotelli, PhD (+390303501457, mcotelli@fatebenefratelli.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cognition as assessed by Montreal Cognitive Assessment (MoCA) (time frame: Baseline up to 5 weeks and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06657274, which also lists 1 linked publication.
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 2 May 2025.