Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
NCT07517380

Exercises for Rehabilitation of COgnition and Lifestyle Enhancement in Patients With Mild Cognitive Impairment

Led by Casa di Cura IGEA · Updated on 2026-04-08

40

Participants Needed

2

Research Sites

62 weeks

Total Duration

On this page

Sponsors

C

Casa di Cura IGEA

Lead Sponsor

U

University of Milano Bicocca

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Exercises for Rehabilitation of COgnition and Lifestyle Enhancement in Patients With Mild Cognitive Impairment

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Mild Cognitive Impairment (MCI) according to established criteria
  • Basic skills in using technological devices or access to someone who can assist
  • Willingness to report any changes in psychotropic or cognition-affecting medications during the study
Not Eligible

You will not qualify if you...

  • Parkinson's disease
  • Linguistic single-domain MCI (possible primary progressive aphasia)
  • Other neurological conditions linked to cognitive impairment, like stroke or brain injury
  • Significant lab abnormalities related to cognitive impairment, such as low vitamin B12 or thyroid disorders
  • Primary psychiatric disorders
  • Alcohol or substance use disorder in the past 10 years
  • Severe behavioral problems limiting group participation
  • Hearing or vision impairments interfering with assessment or treatment
  • Medical conditions preventing study completion
  • Participation in other neuropsychological rehabilitation during the study
  • Refusal to sign informed consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Casa di Cura Igea

Milan, Milano, Italy, 20144

Not Yet Recruiting

2

Casa di Cura Igea

Milan, Milan, Italy, 20144

Actively Recruiting

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Research Team

S

Sabrina Guzzetti Neuropsychologist

CONTACT

G

Giulia Gilardone Neuropsychologist

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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