An interventional study of Tele-rehabilitation in Cognitive Dysfunction, Mild Cognitive Impairment and Vascular Cognitive Impairment, sponsored by Fondazione Don Carlo Gnocchi Onlus. Completed at 1 site in Italy. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Health services research
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Among 174 studies in Cognitive Dysfunction with a site in Italy — 74 open to participants now, 87 under way, 6 of them phase 3. Cognitive Dysfunction · Italy.
Among the 174 studies in Cognitive Dysfunction with a site in Italy, this one is the 64th largest by enrollment of the 110 interventional ones that give a count, is one of 11 that started in 2018, is one of 92 with no phase, and was the 22nd registered.
3,876 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
Browse Cognitive Dysfunction studies →74 of the 174 studies in Cognitive Dysfunction with a site in Italy are open now. Recruiting first, the newest first:
Istituto per la Ricerca e l'Innovazione Biomedica · Sites in Italy
Ages 18–85 · Healthy volunteers
IRCCS Centro San Giovanni di Dio Fatebenefratelli · Sites in Italy
Ages 18+
Alfonso Magliacano · Sites in Italy
Ages 18–75 · Healthy volunteers
University of Milano Bicocca · Sites in Italy
Ages 65+
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Ages 55–80 · Healthy volunteers
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 753 Cognitive Dysfunction studies recruiting now, 364 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 260 take healthy volunteers.
This study: 65 Years to 80 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
174 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 10 · Phase 3 8 · Phase 4 1
First in 2007; this study’s year is marked. 11 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 60 is close to the median of 64 across 2,797 interventional studies indexed under Cognitive Dysfunction.
Median enrollment 80 across the 110 interventional studies, 182 across the 64 observational. Of the 58 that completed or were terminated, 7 (12%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 174 have an industry lead sponsor. The 10 most frequent:
Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
Fondazione Don Carlo Gnocchi Onlus has 4 studies filed under Cognitive Dysfunction — fewer than ten, so there is no comparison to draw.
23 of the studies in Cognitive Dysfunction with a site in Italy that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT07731191IRCCS Centro San Giovanni di Dio FatebenefratelliDigital Solutions for Predicting the Biological Mechanisms of Alzheimer's Disease Through the Analysis of Risk Factors | 2026-11-15 |
| NCT07286448Giovanna ZamboniPersonalized Digital Training for COGnitive FITness in Mild Cognitive Impairment | 2026-11-30 |
| NCT06701630Casa di Cura IGEAItalian Adaptation and Validation of Functional and Behavioural Scales for Subjective Cognitive Decline, Mild Cognitive Impairment and Mild Dementia. | 2026-11-30 |
| NCT07616050Marta MondelliniEvaluation of the Impact of Virtual Park on Training Motivation in Adult Patients | 2026-12 |
Add all 23 to your calendar (.ics) → With an account.
Among the 174 studies in Cognitive Dysfunction with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Aging is often associated with pathological pathway such as in Mild Cognitive Impairment (MCI), and that pathway may be associated to a high risk of dementia.
Tools for early identification of functional and cognitive decline and effectiveness of treatments in counteracting the loss of functionality to preserve MCI subjects autonomy, have been widely debated in recent years.
In literature, the importance of combined cognitive and physical training is also recognized (Karssemeijer E, 2017).
Moving from the above mentioned findings and considerations, the aim of GOAL project is to test a newly developed tele-rehabilitation platform to monitor and preserve functional and cognitive abilities in individuals affected by Mild Cognitive Impairment (MCI).
Participants will be enrolled and randomly assigned to the tele-rehabilitation (GOAL group) or usual care program (control group). A dedicated application will be developed for the GOAL group. Thanks to the application, the participant will access different contents, such as serious games to train cognitive abilities (Anguera et al,2013) and physical training video lessons to endorse daily activity. Each participant of GOAL group will be provided with a tablet, with the application installed on it, and an internet connection (if needed).
30 patients will be allocated in the treatment arm (Telerehabilitation program, GOAL group) by randomization. Randomization will be applied with a ratio of 1:1.
The Telerehabilitation program is conceived as a combined protocol to train both cognitive and physical domains. Participants will be requested to perform the cognitive training three times weekly and physical training two times weekly, on alternate days. The subject will access the Telerehabilitation contents by using a web application configured on a touchscreen notebook, that will be provided to each participant by the research institute.
Physical exercises are going to be chosen according to adaptive physical activity model, and each session will be made up of eleven exercises, divided in three categories: warm-up, strengthening and stretching/relaxation. The participants will perform the exercises according to instructions received in a sequence of videos. Every session will last 30 minutes.
Cognitive training will be based on BrainHQ exercises (BrainHQ, Posit Science,USA) which are characterized by adaptive control of the difficulty levels. The chosen exercises aim to train different cognitive domains including: attention, executive function, memory, processing speed, reasoning, and visuospatial memory. Each session will last 20 minutes, and will include four different types of exercise.
While enrolled in the 8 weeks program, participants will also be requested to wear an actigraph. The actigraph will be placed on the non-dominant arm and will be used to monitor daily activity and sleep quality.
At the end of the tele-rehabilitation program, participants will undergo a final assessment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In case of MCI due to Alzheimer Disease (AD), additional inclusion criteria are:
In case of MCI due to Vascular Cognitive Impairment, additional inclusion criteria are:
Presence of at least one of the following conditions, as assessed by TC scan or encephalic MRI
Exclusion Criteria:
Having relapsing systemic disease and presence of major head trauma
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tele-rehabilitation arm undergo a home-based rehabilitation combined protocol, made up of cognitive and physical exercises
Other: Tele-rehabilitation
Control group receives only verbal instructions to train cognitive and physical conditions. Instructions will aim to promote daily and leisure activities.
Each subject undergoes a combined rehabilitation protocol, which will be administered on a daily basis, designed to alternate physical exercises and cognitive training. Each daily session lasts between 30 and 45 minutes. The complete protocol lasts 8 weeks.
Comparison between the cognitive ability measured at the end of the treatment (time point 2 months) and at the screening time point
Changes in cognitive ability will be assessed by Montreal Cognitive Assessment (MoCA) Test (Conti et al., 2014)
Time frame: At the screening time point and after 2 months of treatment
Maintenance or improvement of the physical activity
Physical activity performed during the trial will be evaluated through the output of the actigraph device and physical performance using the Short Physical Performance Battery
Time frame: At the screening time point and after 2 months of treatment
Copy and Recall of Rey's Figure
Copy and Recall of Rey's Figure ( Caffarra et al., 2002)
Time frame: At the screening time point and after 2 months of treatment
Verbal fluency task
Verbal fluency task (semantic - Novelli et al, 1986 - and phonemic - Carlesimo et al, 1996)
Time frame: At the screening time point and after 2 months of treatment
Stroop Test
Stroop Test (short version; Caffarra et al., 2002)
Time frame: At the screening time point and after 2 months of treatment
Serious Game test
Serious Game test (Zucchella et al, 2014)
Time frame: At the screening time point and after 2 months of treatment
Plan to share: Undecided
Ran from Jan 2018 to primary completion in Oct 2018, 9 months.
Of 1,449 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's 9 months is below that.
Counting every sponsor, half of 1,518 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Fondazione Don Carlo Gnocchi Onlus →