Validation of a Digital Intervention to Rehabilitate Cognitive Resources

Not Applicable

Not yet recruiting

• Conditions: Mild Cognitive Impairment (MCI); Subjective Memory Complaint; Dementia Alzheimer Type

• Registration Number: NCT07064226
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief Summary

The goal of this clinical trial is to learn if the use of a digital cognitive rehabilitation system named RICORDO, that is flexible and capable of adapting the rehabilitation pathway according to the needs and capacity of the patients will prove effective for subjects with Subjective Memory Complaint or with Mild Cognitive Impairment or with Mild Dementia.

The main questions it aims to answer are:

Will the RICORDO rehabilitation treatment, lead to an improvement in the global cognitive level? Will the RICORDO rehabilitation treatment lead to improved activation of participants in managing their own health and healthcare? Researchers will compare the multidomain cognitive rehabilitation strategy of RICORDO digital solution, with a standard paper pencil rehabilitation care (usual care).

Participants will undergo a comprehensive neuropsychological evaluation immediately before, immediately after and six months after the completion of the rehabilitation program.

Both interventions, the experimental and the usual care, will last 5 weeks, with 3 weekly sessions of 45 minutes each and can be done autonomously by the patient at home.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Study Start: 2025-09-10
• Primary Completion: 2027-08-31
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Montreal Cognitive Assessment (MoCA) score > 17.79 (Dapor et al., 2025);
2. Clinical Dementia Rating (CDR) Scale score ≤ 1 (Morris, 1993);
3. Education level > 3 years;
4. Age ≥ 65 years;
5. Informed consent to participate, confirmed by signing the consent form;
6. Availability of a caregiver/study partner able to support the participant;
7. Absence of dysmetria or marked auditory/visual or communication disorders;
8. No ongoing rehabilitation program at the time of enrollment or in the 3 months prior to enrollment;
9. Stable pharmacological treatment (past 3 months) with acetylcholinesterase inhibitors, if applicable.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment MoCA (Dapor et al., 2025)	Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)	MoCA is a screening test for cognitive deficits. It measures the global cognitive functioning and includes several tasks involving different domains: visuospatial/executive function, language, selective and sustained attention, abstraction, memory and orientation. Higher scores indicate better general cognitive performance.
Change in Activation level of Patients measured by Patient Activation Measure 13 (PAM13; Hibbard et al., 2004)	Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)	The Patient Activation Measure (PAM-13) is a 13-item instrument designed to evaluate an individual's knowledge, skills, and confidence in effectively managing their health and healthcare. The total PAM-13 score ranges from 0 to 100, with higher scores indicating greater levels of activation and more favorable outcomes. Individuals classified in the lowest activation level typically lack awareness of their role in managing their health, demonstrate limited health-related knowledge, and possess underdeveloped self-management abilities. In contrast, those in the highest activation level exhibit proactive health behaviors, possess well-established self-management competencies, and demonstrate resilience in response to stress or health-related changes.

Secondary Outcome Measures

Name	Time	Method
Change in memory in everyday situations measured by Everyday Memory Questionnaire Revised (Royle and Lincoln, 2008)	Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)	The Everyday Memory Questionnaire (EMQ) is a self-report instrument designed to assess subjective experiences of memory failure in daily life. The revised version comprises 13 items, each describing a specific memory-related situation. Respondents rate the frequency with which they experience each situation using a 5-point Likert scale. The total score is calculated as the sum of all item responses, with higher scores indicating a greater frequency of everyday memory lapses.
Change in depressive symptoms measured by Beck Depression Inventory II (Beck et al., 1988)	Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)	The Beck Depression Inventory II is a self report questionnaire to evaluate the depression level. It consists of 21 questions, each scored on a 4-point scale, with a total score ranging from 0 to 63. The total score is calculated by summing the responses to all 21 questions. HIgher scores indicate more severe deflection of mood tone. The BDI-II can be used to assess the effectiveness of treatment interventions.
Change in mood measured by Positive and Negative Affect Scale (PANAS)	Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)	The Positive and Negative Affect Schedule (PANAS) is a self-administered questionnaire designed to assess affective states. It consists of two distinct subscales that measure positive affect (PA) and negative affect (NA), respectively. Each subscale comprises ten descriptive adjectives, with participants rating the extent to which they have experienced each emotion on a 5-point Likert scale, ranging from 1 (very slightly or not at all) to 5 (extremely). The overall PANAS score is calculated by summing the ratings for the items within each subscale, yielding separate PA and NA scores. Higher scores on each subscale reflect greater intensity of the corresponding affect. In scoring, values from the positive affect items contribute to the PA score, while values from the negative affect items contribute to the NA score.
Change in anxiety level measured by State-Trait Anxiety Inventory (STAI- Y state)	Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)	The STAI-Y is a frequeltly used self-reported questionnaire to measure state anxiety (20 items). Each item is rated on a 4-point scale (from "Almost Never" to "Almost Always"). STAI is scored by summing ratings for each item (range 0-80). Higher scores indicate greater anxiety.
Change in long term visual memory measured by Free and Cued Selective Reminding Test (FCSRT) (Frasson et al., 2011)	Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)	The Free and Cued Selective Reminding Test (FCSRT) is a visual memory assessment designed to optimize encoding specificity. It evaluates both immediate (learning) and delayed (long-term) recall of visually presented stimuli. The test is structured into three phases: (1) Encoding phase - participants are asked to name stimuli presented on three boards, each containing four color images, followed by a cueing procedure to ensure proper encoding; (2) Immediate recall phase - participants undergo three trials of free recall followed by cued recall for any items not retrieved spontaneously, with an interference task administered between trials; (3) Delayed recall phase - after a 30-minute interval filled with non-verbal tasks, participants complete a delayed free recall followed by cued recall for any missed items. The test yields six scores: Immediate Free Recall (range 0-36), Immediate Total Recall (range 0-36), Delayed Free Recall (range 0-12), Delayed Total Recall (range 0-12),
Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT parts A and B) (Giovagnoli et al., 1996)	Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)	The Trail Making Test (TMT) is a neuropsychological test used to assess attention, mental flexibility, and motor coordination. It involves connecting a sequence of targets (numbers or alternating numbers and letters) as quickly as possible, while maintaining accuracy. The test has two parts, A and B, with Part B requiring a switch in task requirements. The scoring of TMT consists in the time used to complete each part of the test. Higher execution times indicate poorer performance.
Change in Verbal and Semantic fluency evaluated by Phonemic/Semantic alternate fluency test (Costa et al., 2014)	Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)	The Phonemic/Semantic Alternate Fluency Test (Costa et al., 2014) is a verbal fluency task designed to assess executive functioning, particularly cognitive flexibility and lexical access. Participants are required to alternately generate words beginning with a specific letter (phonemic fluency) and belonging to a specific semantic category (semantic fluency) within a limited time frame. This alternating condition increases task complexity and places greater demands on mental set shifting compared to traditional fluency tasks.
Change in visuospatial,nonverbal memory and praxia abilities evaluated by Benson Figure Copy and recall (Possin et al., 2011)	Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)	The Benson Figure Test is a neuropsychological assessment used to evaluate visuospatial abilities, visual memory, and constructional skills. Patients are asked to copy a complex figure and to recall it after 10 minutes.
Change in Theory of Mind evaluated by Yoni-48 task (Isernia et al., 2023)	Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)	The Yoni-48 task is a computerized measure of Theory of Mind (ToM), specifically designed to assess first- and second-order affective and cognitive mentalizing. It consists of 48 visual stimuli presented on a computer screen, where a cartoon character named "Yoni" is shown with four surrounding elements. The mental stimuli comprise 21 affective and 21 cognitive ToM items and are divided into 16 first-order (8 affective, 8 cognitive) and 26 second-order (13 affective and 13 cognitive) ToM stimuli.
Change in patient's self-rated health measured by EuroQol five dimensions (5D) and five levels (5L) (Balestroni and Bertolotti, 2012)	Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)	The EQ-5D-5L is a standardized measure of health status, consisting of two parts: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS captures the patient's self-rated health on a vertical visual analogue scale, with endpoints labeled 'The best health you can imagine' (scored as 100) and 'The worst health you can imagine' (scored as 0).

Trial Locations

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi ONLUS; Center of Advance Diagnostic and Therapy ( CADiTeR); 🇮🇹 Milano, Italy