Mild Cognitive Impairment (MCI) is a clinical condition with a heterogeneous etiology and clinical course characterized by objective cognitive deficits not severe enough to cause clear functional limitations or to warrant a diagnosis of dementia. Since MCI represents a risk factor for progression to various forms of dementia, timely preventive intervention is essential, although outpatient cognitive rehabilitation for this population is still limited by issues related to service accessibility.
This study aims to investigate the effectiveness of a multimodal group cognitive rehabilitation intevention designed to be accessible for patients with MCI and sustainable in clinical practice.
The primary objective of the study is to evaluate the effects of the intervention on cognitive, behavioural, and functional profile of patients with MCI, compared with an active control group. Outcome measures will be collected for all participants at T0 (baseline), T1 (after 12 weeks of intervention), and T2 (3 months after the end of the intervention and approximately 6 months from baseline), in order to assess both short-term and long-term effects of the intervention. The secondary objective is to explore the relationship between changes in outcome measures in the experimental group following the intervention and patients' demographic and clinical characteristics, with the aim of identifying potential predictors of a greater response to the intervention. Treatment accessibility, which guided the study design, will be evaluated though dropout and attendance rates, use of the provided tools and responses to the final satisfaction questionnaire.
The experimental group will receive a multimodal cognitive rehabilitation intervention, including (a) a multi-domain cognitive training and (b) a lifestyle intervention, consisting of psychoeducational sessions on neuroprotective factors and supported by the use of a web-based application accessible via computer and tablet. The intervention program will be delivered in small groups, with two 60-minute sessions per week over 12 weeks. The intervention was designed to enhance accessibility and sustainability by limiting intervention intensity and duration, using technology, and delivering group-based rehabilitation in groups that are not highly homogeneous. This approach is expected to result in a better cost-benefit balance and greater transferability to clinical practice. The control group will receive an informational booklet on neuroprotective factors, including practical daily-life recommendations to reduce risk profiles.
Forty patients with MCI and their informants will be recruited and randomly assigned to the experimental or control group. Participants in the experimental group will be further divided into small subgroups based on the presence of memory impairment.
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.
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).
Parallel
Multimodal Group Cognitive Rehabilitation Intervention
BehavioralThe multimodal Group Cognitive Rehabilitation Intervention included a multi-domain cognitive training and a lifestyle intervention. The exercise package adopted in the multi-domain cognitive training will be adapted from that used in a previous cognitive enhancement study by Tagliabue and colleagues (2018) conducted in neurologically healthy adults over 60. The lifestyle intervention will consist of psychoeducational sessions on neuroprotective factor and supported by the use of a web-based application accessible via computer and tablet. The intervention program will be delivered in small groups formed according to the presence of memory impairment, with two 60-minute sessions per week for a total of 12 weeks.
Active Control
BehavioralThe control group will receive an informational booklet on the 14 protective factors for dementia described by the Lancet Commission in 2024, including practical daily-life recommendations to reduce risk. An ad hoc questionnaire will be administered to the patients assigned to the control condition and to one of their family members every two weeks for a period of 12 weeks, in order to monitor patients' efforts and progress in following the recommendations provided.
Montreal Cognitive Assessment (MoCA) score
The Montreal Cognitive Assessment (MoCA) is a cognitive test specifically developed for the detection of MCI and is recommended as the preferred tool for screening patients with suspected MCI. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Forward Digit span
It assesses verbal short-term memory. Scores range from 0 to 9, with higher scores indicating better cognitive function.
Copy of the Modified Taylor Complex Figure
This test evaluates visual-constructional ability. Scores range from 0 to 36, with higher scores indicating better cognitive function.
Rey Auditory Verbal Learning Test (RAVLT)
It evaluates the ability to encode, consolidate, store, recall, and recognize verbal information.
Functional Activities Questionnaire (FAQ)
It evaluates functional autonomy in complex everyday activities.
Neuropsychiatric Inventory Questionnaire (NPI-q)
It assesses a wide range of neuropsychiatric symptoms.
Geriatric Depression Scale (GDS)
It evaluates depressive symptoms in geriatric population. Scores range from 0 to 30, with scores higher than 9 indicating depressive symptoms.
Self-reported 12-item Short Form questionnaire (SF-12)
It evaluates quolity of life.
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Casa di Cura IGEA
Lead sponsor
University of Milano Bicocca
Collaborator
