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
NCT06657274, Not applicable, Recruiting, IRCCS Centro San Giovanni di Dio Fatebenefratelli
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| 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 |
| NCT number | NCT06657274 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment (MCI), Subjective Cognitive Complaints (SCCs), Parkinson Disease | ClinicalTrials.gov |
| Interventions | RICORDO-DTx, Home-based unstructured cognitive stimulation | ClinicalTrials.gov |
| First posted | 2024-10-24 | ClinicalTrials.gov |
| Last updated | 2025-05-02 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in global cognition as assessed by Montreal Cognitive Assessment (MoCA) | 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). | ClinicalTrials.gov |
| Primary | Change in long-term episodic verbal memory as assessed by Free and Cued Selective Reminding Test (FCSRT) | 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. | ClinicalTrials.gov |
| Secondary | Change in measure of quality of life as assessed by EQ-5D-5L | Baseline up to 5 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in measure of non-motor experiences of daily living as assessed by MDS-UPDRS scale, part I | Baseline up to 5 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in measure of motor abilities as assessed by MDS-UPDRS scale, part III | Baseline up to 5 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in depressive symptoms as assessed by Hamilton Depression Rating Scale (HDRS) | Baseline up to 5 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in anxiety symptoms as assessed by State-Trait Anxiety Inventory (STAI-Y) | Baseline up to 5 weeks and 3 months | 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. | ClinicalTrials.gov |
| Secondary | Change in behavior and personality as assessed by Neuropsychiatric Inventory (NPI) | Baseline up to 5 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in memory complaints as assessed by Everyday Memory Questionnaire (EMQ) | Baseline up to 5 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in non-verbal abstract reasoning as assessed by Raven's Coloured Progressive Matrices | Baseline up to 5 weeks and 3 months | Raven's Coloured Progressive Matrices is a measure of non-verbal abstract reasoning (score range min= 0, max= 36, higher score=better outcome). | ClinicalTrials.gov |
| Secondary | Change in measure of attentional abilities as assessed by Trial Making Test (TMT) | Baseline up to 5 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in measure of executive abilities as assessed by Stroop Test | Baseline up to 5 weeks and 3 months | 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. | ClinicalTrials.gov |
| Secondary | Change in measure of constructional praxia as assessed by Rey-Osterrieth Complex Figure-Copy | Baseline up to 5 weeks and 3 months | Rey-Osterrieth Complex Figure-Copy is a measure of constructional praxia (score range min= 0, max= 36, higher score=better outcome). | ClinicalTrials.gov |
| Secondary | Change in measure of fluency abilities as assessed by Verbal Fluency (semantic and phonemic) | Baseline up to 5 weeks and 3 months | 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). | ClinicalTrials.gov |
| Secondary | Change in measure of nonverbal long-term memory as assessed by Rey-Osterrieth Complex Figure-Recall | Baseline up to 5 weeks and 3 months | Rey-Osterrieth Complex Figure-Recall is a measure of nonverbal long-term memory (score range min= 0, max= 36, higher score=better outcome). | ClinicalTrials.gov |
| Secondary | Change in NFL and Tau | Baseline up to 5 weeks | Neurofilament light chain (NFL) and Tau levels | ClinicalTrials.gov |
| Secondary | Change in Aß1-40, Aß1-42, p-tau-181; p-tau-231, alpha-synuclein | Baseline up to 5 weeks | Aß1-40, Aß1-42, p-tau-181; p-tau-231, alpha-synuclein levels | ClinicalTrials.gov |
| Secondary | Change in GFAP, chemokines and sTREM2 | Baseline up to 5 weeks | Glial Fibrillary Acidic Protein (GFAP), chemokines and sTREM2 levels | ClinicalTrials.gov |
| Secondary | Change in Neurogranin and BDNF | Baseline up to 5 week | Neurogranin and Brain-Derived Neurotrophic Factor (BDNF) levels | ClinicalTrials.gov |
| Secondary | Change in plasma EVs | Baseline up to 5 weeks | Size and the concentration of plasma Extracellular Vescicles (EVs) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 40149761 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Delayed Recall Module | Primary outcome | ConductCognition |
| Selective Reminding Task | Primary outcome | ConductCognition |
| Category Fluency | Secondary outcome | ConductCognition |
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Matrix Reasoning | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)