Mild Cognitive Impairment (MCI)MI-RICORDONCT07064226
Validation of a Digital Intervention to Rehabilitate Cognitive Resources
A study testing RICORDO and Treatment as Usual (TAU) in people with Mild Cognitive Impairment (MCI) and Subjective Memory Complaint, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Subjective Memory Complaint, Dementia Alzheimer Type
- What is being tested?
- RICORDO and Treatment as Usual (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- 6 Oct 2025to 30 Sep 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Montreal Cognitive Assessment (MoCA) score > 17.79;
- Clinical Dementia Rating (CDR) Scale score ≤ 1;
- Education level > 3 years;
- Age ≥ 65 years;
- Informed consent to participate, confirmed by signing the consent form;
- Availability of a caregiver/study partner able to support the participant;
- Stable pharmacological treatment (past 3 months) with acetylcholinesterase inhibitors, if applicable.
Who cannot join
- Presence of dysmetria or marked auditory/visual or communication disorders preventing the participation to the trial;
- Presence of ongoing rehabilitation program at the time of enrollment or in the 3 months prior to enrollment;
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, 1 recruiting
- Recruiting
IRCCS Fondazione Don Carlo Gnocchi ONLUS; Center of Advance Diagnostic and Therapy ( CADiTeR)
Milan, 20148
Valeria Blasi, MD, +390240308952, vblasi@dongnocchi.it
About this study
Official title: Transcultural and Multidimensional Validation of dIgital Rehabilitation Intervention of COgnitive Resources Domain-Oriented - Work Package 4
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:
Read more
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.
- Being tested
- RICORDO, Treatment as Usual (TAU)
- Keywords
- telerehabilitation, Alzheimer disease, cognitive decline, cognitive rehabilitation, Digital medicine, Dementia, Mild Cognitive Impairment, neuroimaging
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RICORDOOther
During the RICORDO intervention, participants will engage in a multidomain cognitive telerehabilitation program using a digital platform ([http://www.ricordo-dtx.com/]), which allows for personalized interventions through an adaptive algorithm allowing an increment in task difficulties according to patients' needs. The treatment can be self-administered by the patient at home. The program lasts five weeks, with three treatment sessions per week, each lasting approximately 45 minutes.
The active control group (TAU) will undergo the same type of treatment with the following differences: the digital platform will not be used, as the treatment will consist solely of paper-and-pencil exercises; and there will be no personalization of the exercises, since automatic adaptation is not possible.
As described above, this type of intervention will consist in a multidomain cognitive rehabilitation treatment to be self administered by the participants at home with pencil paper excercises. Treatment will last 5 weeks, 3 sessions per week, each lasting approximately 45 minutes. The treatment will follow a predefined incremental difficulty structure since no personalization is available.
| Study group | Role | What they receive |
|---|---|---|
| RICORDO | Experimental | Participants will carry out telerehabilitation using a digital platform [http://www.ricordo-dtx.com/], at home, autonomously. Receives: Other: RICORDO |
| Treatment as Usual (TAU) | Active comparator | Participants will follow a traditional paper-and-pencil rehabilitation protocol at home, autonomously. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment MoCA
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. Score ranges from 0 to 30 with higher scores indicating better general cognitive performance.
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in Activation level of Patients measured by Patient Activation Measure 13 (PAM13)
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.
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Secondary outcomes (11)
Change in memory in everyday situations measured by Everyday Memory Questionnaire Revised
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 and ranges from 0 to 52, with higher scores indicating a greater frequency of everyday memory lapses.
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in depressive symptoms measured by Beck Depression Inventory II
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.
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in mood measured by Positive and Negative Affect Scale (PANAS)
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. Score ranges from 10 to 50. 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.
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in anxiety level measured by State-Trait Anxiety Inventory (STAI- Y state)
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.
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in Language and Executive Functions evaluated by Phonemic/Semantic alternate fluency test
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.
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in visuospatial abilities evaluated by Benson Figure Copy and recall
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.
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT parts A and B)
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.
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in patient's self-rated health measured by EuroQol five dimensions (5D) and five levels (5L)
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).
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in immediate recall memory measured by the Free and Cued Selective Reminding Test (FCSRT)
The patient is instructed to freely and cuedly recall as many items as possible. The score corresponds to the total number of recalled items across the three immediate trials (range: 0-36). Higher scores indicate greater memory performance.
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in delayed recall memory measured by the Free and Cued Selective Reminding Test (FCSRT)
The patient is asked to recall as many items as possibile after 30 min from learning phase. The score corresponds to the number of recalled items across the three trials (range: 0-12).
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in Theory of Mind ability evaluated by Yoni-48 task
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 mentalizing 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. the remaining 6 are non mentalizing - control items. The scores are summed and adjusted for demographics to compute an accuracy index ranging from 0 (poorer performance) to 1 (better performance).
Measured: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start6 Oct 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control study with 2 groups: experimental rehabilitation intervention (Ricordo) vs Treatment as usual
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Università Carlo Cattaneo , Castellanza, Astir s.r.l.
- Responsible party
- Sponsor
- Investigators
- Valeria Blasi, Medical Doctor, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi ONLUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064226
- Sponsor's protocol ID
- MI-RICORDO
- Other IDs
- FP-1321
- Acronym
- MI-RICORDO
- Status last verified
- Nov 2025
- First submitted
- 3 Jul 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spielberger CD, Gorsuch RL, Lushene RE, et al. State-Trait Anxiety Inventory for adults: manual, instrument and scoring guide. Palo Alto: Mind Garden; 1983
BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.
PubMed 8232972Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. doi: 10.4081/monaldi.2012.121. Italian.
PubMed 23614330Isernia S, Rossetto F, Shamay-Tsoory S, Marchetti A, Baglio F. Standardization and normative data of the 48-item Yoni short version for the assessment of theory of mind in typical and atypical conditions. Front Aging Neurosci. 2023 Jan 12;14:1048599. doi: 10.3389/fnagi.2022.1048599. eCollection 2022.
PubMed 36711213Possin KL, Laluz VR, Alcantar OZ, Miller BL, Kramer JH. Distinct neuroanatomical substrates and cognitive mechanisms of figure copy performance in Alzheimer's disease and behavioral variant frontotemporal dementia. Neuropsychologia. 2011 Jan;49(1):43-8. doi: 10.1016/j.neuropsychologia.2010.10.026. Epub 2010 Oct 26.
PubMed 21029744Costa A, Bagoj E, Monaco M, Zabberoni S, De Rosa S, Papantonio AM, Mundi C, Caltagirone C, Carlesimo GA. Standardization and normative data obtained in the Italian population for a new verbal fluency instrument, the phonemic/semantic alternate fluency test. Neurol Sci. 2014 Mar;35(3):365-72. doi: 10.1007/s10072-013-1520-8. Epub 2013 Aug 21.
PubMed 23963806Giovagnoli AR, Del Pesce M, Mascheroni S, Simoncelli M, Laiacona M, Capitani E. Trail making test: normative values from 287 normal adult controls. Ital J Neurol Sci. 1996 Aug;17(4):305-9. doi: 10.1007/BF01997792.
PubMed 8915764Frasson P, Ghiretti R, Catricala E, Pomati S, Marcone A, Parisi L, Rossini PM, Cappa SF, Mariani C, Vanacore N, Clerici F. Free and Cued Selective Reminding Test: an Italian normative study. Neurol Sci. 2011 Dec;32(6):1057-62. doi: 10.1007/s10072-011-0607-3. Epub 2011 May 19.
PubMed 21594655Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Royle J, Lincoln NB. The Everyday Memory Questionnaire-revised: development of a 13-item scale. Disabil Rehabil. 2008;30(2):114-21. doi: 10.1080/09638280701223876.
PubMed 17852284Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
PubMed 15230939Dapor C, Devita M, Iannizzi P, Arbia E, Bruzzano A, Dessi M, Lupi D, Rolandino GM, Rossi M, Saccomano A, Siccardi E, Simonetto A, Vuerich G, Zuliani S, Priftis K. The Montreal cognitive assessment (MoCA) 8.1 version, including the memory index score (MoCA-MIS): Italian norms. Neurol Sci. 2025 Jun;46(6):2581-2589. doi: 10.1007/s10072-025-08066-1. Epub 2025 Mar 17.
PubMed 40095163Blasi V, Isernia S, Rossetto F, Pagliari C, Borgnis F, Pirastru A, Marzulli M, Foglia E, Garagiola E, Baglio F. Study protocol for a randomized controlled trial assessing clinical efficacy of digital cognitive rehabilitation for preclinical and mild clinical stages of alzheimer's disease continuum: the MI-RICORDO project. BMC Psychiatry. 2025 Nov 11;25(1):1075. doi: 10.1186/s12888-025-07531-7.
PubMed 41219714
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcultural and Multidimensional Validation of dIgital Rehabilitation Intervention of COgnitive Resources Domain-Oriented - Work Package 4
- ClinicalTrials.gov ID
- NCT07064226
- Acronym / sponsor ID
- MI-RICORDO / MI-RICORDO
- Keywords
- telerehabilitation, Alzheimer disease, cognitive decline, cognitive rehabilitation, Digital medicine, Dementia, Mild Cognitive Impairment, neuroimaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Università Carlo Cattaneo , Castellanza, Astir s.r.l.
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Jul 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control study with 2 groups: experimental rehabilitation intervention (Ricordo) vs Treatment as usual
| Arm | Type | Receives |
|---|---|---|
| RICORDO | Experimental | Other: RICORDOParticipants will carry out telerehabilitation using a digital platform [http://www.ricordo-dtx.com/], at home, autonomously. |
| Treatment as Usual (TAU) | Active comparator | Other: Treatment as Usual (TAU)Participants will follow a traditional paper-and-pencil rehabilitation protocol at home, autonomously. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Montreal Cognitive Assessment (MoCA) score > 17.79;
- Clinical Dementia Rating (CDR) Scale score ≤ 1;
- Education level > 3 years;
- Age ≥ 65 years;
- Informed consent to participate, confirmed by signing the consent form;
Key exclusion criteria (2 listed)
- Presence of dysmetria or marked auditory/visual or communication disorders preventing the participation to the trial;
- Presence of ongoing rehabilitation program at the time of enrollment or in the 3 months prior to enrollment;
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 |
|---|---|---|
| RICORDODuring the RICORDO intervention, participants will engage in a multidomain cognitive telerehabilitation program using a digital platform ([http://www.ricordo-dtx.com/]), which allows for personalized interventions through an adaptive algorithm allowing an increment in task difficulties according to patients' needs. The treatment can be self-administered by the patient at home. The program lasts five weeks, with three treatment sessions per week, each lasting approximately 45 minutes. The active control group (TAU) will undergo the same type of treatment with the following differences: the digital platform will not be used, as the treatment will consist solely of paper-and-pencil exercises; and there will be no personalization of the exercises, since automatic adaptation is not possible. | Other | RICORDO |
| Treatment as Usual (TAU)As described above, this type of intervention will consist in a multidomain cognitive rehabilitation treatment to be self administered by the participants at home with pencil paper excercises. Treatment will last 5 weeks, 3 sessions per week, each lasting approximately 45 minutes. The treatment will follow a predefined incremental difficulty structure since no personalization is available. | Other | Treatment as Usual (TAU) |
Primary outcome
Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment MoCA
Time frame: 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. Score ranges from 0 to 30 with higher scores indicating better general cognitive performance.
Change in Activation level of Patients measured by Patient Activation Measure 13 (PAM13)
Time frame: 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.
11 secondary outcomes
Change in memory in everyday situations measured by Everyday Memory Questionnaire Revised
Time frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in depressive symptoms measured by Beck Depression Inventory II
Time frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in mood measured by Positive and Negative Affect Scale (PANAS)
Time frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in anxiety level measured by State-Trait Anxiety Inventory (STAI- Y state)
Time frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in Language and Executive Functions evaluated by Phonemic/Semantic alternate fluency test
Time frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in visuospatial abilities evaluated by Benson Figure Copy and recall
Time frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in visuoperceptual and attentional abilities measured by Trail Making Test (TMT parts A and B)
Time frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in patient's self-rated health measured by EuroQol five dimensions (5D) and five levels (5L)
Time frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in immediate recall memory measured by the Free and Cued Selective Reminding Test (FCSRT)
Time frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in delayed recall memory measured by the Free and Cued Selective Reminding Test (FCSRT)
Time frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
Change in Theory of Mind ability evaluated by Yoni-48 task
Time frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)
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 13 Feb 2026.
- BackgroundSpielberger CD, Gorsuch RL, Lushene RE, et al. State-Trait Anxiety Inventory for adults: manual, instrument and scoring guide. Palo Alto: Mind Garden; 1983
- Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Background: PubMed 8232972Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.
- Background: PubMed 23614330Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. doi: 10.4081/monaldi.2012.121. Italian.
- Background: PubMed 36711213Isernia S, Rossetto F, Shamay-Tsoory S, Marchetti A, Baglio F. Standardization and normative data of the 48-item Yoni short version for the assessment of theory of mind in typical and atypical conditions. Front Aging Neurosci. 2023 Jan 12;14:1048599. doi: 10.3389/fnagi.2022.1048599. eCollection 2022.
- Background: PubMed 21029744Possin KL, Laluz VR, Alcantar OZ, Miller BL, Kramer JH. Distinct neuroanatomical substrates and cognitive mechanisms of figure copy performance in Alzheimer's disease and behavioral variant frontotemporal dementia. Neuropsychologia. 2011 Jan;49(1):43-8. doi: 10.1016/j.neuropsychologia.2010.10.026. Epub 2010 Oct 26.
- Background: PubMed 23963806Costa A, Bagoj E, Monaco M, Zabberoni S, De Rosa S, Papantonio AM, Mundi C, Caltagirone C, Carlesimo GA. Standardization and normative data obtained in the Italian population for a new verbal fluency instrument, the phonemic/semantic alternate fluency test. Neurol Sci. 2014 Mar;35(3):365-72. doi: 10.1007/s10072-013-1520-8. Epub 2013 Aug 21.
- Background: PubMed 8915764Giovagnoli AR, Del Pesce M, Mascheroni S, Simoncelli M, Laiacona M, Capitani E. Trail making test: normative values from 287 normal adult controls. Ital J Neurol Sci. 1996 Aug;17(4):305-9. doi: 10.1007/BF01997792.
- Background: PubMed 21594655Frasson P, Ghiretti R, Catricala E, Pomati S, Marcone A, Parisi L, Rossini PM, Cappa SF, Mariani C, Vanacore N, Clerici F. Free and Cued Selective Reminding Test: an Italian normative study. Neurol Sci. 2011 Dec;32(6):1057-62. doi: 10.1007/s10072-011-0607-3. Epub 2011 May 19.
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Background: PubMed 17852284Royle J, Lincoln NB. The Everyday Memory Questionnaire-revised: development of a 13-item scale. Disabil Rehabil. 2008;30(2):114-21. doi: 10.1080/09638280701223876.
- Background: PubMed 15230939Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
- Individual participant dataSharing planned: No
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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.
Valeria Blasi, Medical Doctor principal investigator
IRCCS Fondazione Don Carlo Gnocchi ONLUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RICORDO and Treatment as Usual (TAU) in people with Mild Cognitive Impairment (MCI) and Subjective Memory Complaint, run by Fondazione Don Carlo Gnocchi ETS 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 7 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 13 Feb 2026. 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 Valeria Blasi, MD (+390240308952, vblasi@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cognitive functioning and subdomains measured by Montreal Cognitive Assessment MoCA (time frame: Baseline, after 5 weeks (End of treatment), 6 months after baseline (Follow-up)). 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 NCT07064226, which also lists 14 linked publications.
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 13 Feb 2026.