Group exercises to improve thinking and daily lifestyle for people with mild cognitive impairment
Sviluppo di un Intervento di Riabilitazione Cognitiva Applicabile e Sostenibile Nella Pratica Clinica Per i Pazienti Con Mild Cognitive Impairment
This program tests whether a 12-week group multimodal cognitive and lifestyle exercise program can help people with mild cognitive impairment improve thinking, behavior, and everyday functioning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Casa di Cura IGEA Academic / other |
| Locations | 2 sites (Milan, Milano and 1 other locations) |
| Trial ID | NCT07517380 on ClinicalTrials.gov |
What this trial studies
Adults with mild cognitive impairment will be enrolled and assigned to either a multimodal group cognitive rehabilitation program or an active control condition, with outcomes collected at baseline and after 12 weeks. The intervention combines group cognitive training, lifestyle strategies, and technology-supported exercises designed for clinical sustainability and accessibility. Cognitive, behavioral, and functional measures will be used to compare changes between the intervention and active control groups. The design emphasizes a pragmatic, clinic-friendly format to increase service accessibility for patients with MCI.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with MCI per Petersen/Winblad criteria (and Albert criteria when applicable) who have basic technology skills or access to a helper and agree to report medication changes during the study.
Not a fit: People with Parkinson's disease, suspected primary progressive aphasia (linguistic single-domain MCI), other neurological causes of cognitive impairment, significant laboratory abnormalities linked to cognition, or more advanced dementia are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could help people with MCI maintain or improve cognitive skills and daily functioning while providing a more accessible, sustainable rehabilitation option.
How similar studies have performed: Previous meta-analyses and reviews of multimodal and lifestyle-based cognitive rehabilitation in MCI have shown promising improvements in objective cognitive performance, so this approach builds on existing supportive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of MCI according to the diagnostic criteria of Petersen (2004) and Winblad et al. (2004) and, if applicable (i.e., MCI due to AD), according to those of Albert and colleagues (2011). * Self-reported basic skills in using technological devices, or access to a close person able to provide assistance. * Willingness of the patient to report, during the study period, any changes in the dosage of psychotropic drugs or other medications that may affect cognition, such as anticholinergics, opioids, benzodiazepines, antidepressants, muscle relaxants, and antiepileptics. Exclusion Criteria: * Parkinson's disease. * Linguistic single-domain MCI (suspected onset of primary progressive aphasia). * Other neurological conditions potentially associated with cognitive impairment (e.g., previous stroke or traumatic brain injury). * Significant laboratory abnormalities potentially associated with cognitive impairment (e.g., low levels of vitamin B12 or folate, or values indicative of thyroid disorders). * Primary psychiatric disorders. * Alcohol or substance use disorder in the previous 10 years. * Severe behavioral disturbances limiting group participation. * Hearing or visual impairments that may interfere with assessment or treatment. * Medical conditions that may interfere with completion of the study. * Exposure, during the study period, to other neuropsychological rehabilitation interventions. * Patient's refusal to sign the informed consent.
Where this trial is running
Milan, Milano and 1 other locations
- Casa di Cura Igea — Milan, Milano, Italy (Not_yet_recruiting)
- Casa di Cura Igea — Milan, Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Sabrina Guzzetti — Casa di Cura Igea, Milano
- Study coordinator: Sabrina Guzzetti Neuropsychologist
- Email: s.guzzetti@casadicurigea.it
- Phone: +390248593315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.