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

NCT07517380 | Recruiting

• 1 other identifier: CasaCura
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Mild Cognitive Impairment (MCI)

Keywords

Lifestyle Intervention; Cognitive Training Intervention; Non-pharmacological Intervention; Multicomponent Intervention; Group Cognitive Training Intervention; Multimodal Intervention; Digital Health Intervention; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (17)

• 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.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Forward Digit span

  It assesses verbal short-term memory. Scores range from 0 to 9, with higher scores indicating better cognitive function.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• 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.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Rey Auditory Verbal Learning Test (RAVLT)

  It evaluates the ability to encode, consolidate, store, recall, and recognize verbal information.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Boston Naming Test (BNT)

  It assesses the ability to retrieve the names of visually presented objects.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Multiple Features Target Cancellation (MFTC)

  It requires detecting stimuli characterized by a conjunction of visual features, assessing selective attention and visuospatial exploration.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Raven's Colored Progressive Matrices (CPM)

  It evaluates nonverbal abstract reasoning.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Semantic and phonemic fluency

  It evaluates generative language production under restricted search conditions, thus assessing both language ability and executive functions.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Trail Making Test (TMT)

  It assess psychomotor speed, visual attention, and visuomotor coordination in both part A and part B and set-shifting ability in part B.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Weigl sorting test (WST)

  It evaluates non verbal executive functions (visual categorization and self monitoring).

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Stroop color word test

  It assess inhibition mechanisms.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Questionnaire on lifestyle

  It has been developed ad hoc to detect any changes in lifestyle occurring after the intervention.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Forward Corsi span.

  It assesses visuo-spatial short-term memory. Scores range from 0 to 9, with higher scores indicating better cognitive function.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Backward Digit span.

  It assesses verbal working memory. Scores range from 0 to 8, with higher scores indicating better cognitive function.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Backward Corsi span

  It assesse visuospatial working memory. Scores range from 0 to 8, with higher scores indicating better cognitive function.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Free recall of the Modified Taylor Complex Figure

  It assesses visuospatial long-term memory. Scores range from 0 to 36, with higher scores indicating better cognitive function.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Recognition of the Modified Taylor Complex Figure

  It assesses visuospatial long-term memory (recognition component). Scores range from 0 to 10, with higher scores indicating better cognitive function.

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

Secondary Outcomes (4)

• Functional Activities Questionnaire (FAQ)

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Neuropsychiatric Inventory Questionnaire (NPI-q)

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Geriatric Depression Scale (GDS)

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

• Self-reported 12-item Short Form questionnaire (SF-12)

  Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).

Study Arms (2)

Multimodal Group Cognitive Rehabilitation Intervention

EXPERIMENTAL

The experimental group will receive a multimodal group cognitive rehabilitation intervention, including (a) a multi-domain cognitive training and (b) a lifestyle intervention.

Behavioral: Multimodal Group Cognitive Rehabilitation Intervention

Active Control Condition

OTHER

The patients assigned to the active control condition 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.

Behavioral: Active Control

Interventions

Multimodal Group Cognitive Rehabilitation Intervention BEHAVIORAL

The 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.

Also known as: Multicomponent Group Cognitive Rehabilitation Intervention

Multimodal Group Cognitive Rehabilitation Intervention

Active Control BEHAVIORAL

The 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.

Active Control Condition

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Casa di Cura IGEA: lead
• University of Milano Bicocca: collaborator

Study Sites (2)

Casa di Cura Igea

Milan, Milano, 20144, Italy

NOT YET RECRUITING

Casa di Cura Igea

Milan, Milan, 20144, Italy

RECRUITING

Related Publications (10)

• Canevelli M, Di Pucchio A, Marzolini F, Mayer F, Massari M, Salvi E, Palazzesi I, Lacorte E, Bacigalupo I, Di Fiandra T, Vanacore N. A National Survey of Centers for Cognitive Disorders and Dementias in Italy. J Alzheimers Dis. 2021;83(4):1849-1857. doi: 10.3233/JAD-210634.

  PMID: 34459403 BACKGROUND

• Bruscoli M, Lovestone S. Is MCI really just early dementia? A systematic review of conversion studies. Int Psychogeriatr. 2004 Jun;16(2):129-40. doi: 10.1017/s1041610204000092.

  PMID: 15318760 BACKGROUND

• Huckans M,Hutson L,Twamley E,Jak A,Kaye J,Storzbach D

  BACKGROUND

• Sherman DS,Mauser J,Nuno M,Sherzai D

  BACKGROUND

• Shao Z, Hu M, Zhang D, Zeng X, Shu X, Wu X, Kwok TCY, Feng H. Dose-response relationship in non-pharmacological interventions for individuals with mild cognitive impairment: A systematic review and meta-analysis of randomised controlled trials. J Clin Nurs. 2022 Dec;31(23-24):3390-3401. doi: 10.1111/jocn.16240. Epub 2022 Jan 30.

  PMID: 35098610 BACKGROUND

• Petersen RC. Mild cognitive impairment as a diagnostic entity. J Intern Med. 2004 Sep;256(3):183-94. doi: 10.1111/j.1365-2796.2004.01388.x.

  PMID: 15324362 BACKGROUND

• Winblad B, Palmer K, Kivipelto M, Jelic V, Fratiglioni L, Wahlund LO, Nordberg A, Backman L, Albert M, Almkvist O, Arai H, Basun H, Blennow K, de Leon M, DeCarli C, Erkinjuntti T, Giacobini E, Graff C, Hardy J, Jack C, Jorm A, Ritchie K, van Duijn C, Visser P, Petersen RC. Mild cognitive impairment--beyond controversies, towards a consensus: report of the International Working Group on Mild Cognitive Impairment. J Intern Med. 2004 Sep;256(3):240-6. doi: 10.1111/j.1365-2796.2004.01380.x.

  PMID: 15324367 BACKGROUND

• Livingston G, Huntley J, Liu KY, Costafreda SG, Selbaek G, Alladi S, Ames D, Banerjee S, Burns A, Brayne C, Fox NC, Ferri CP, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Nakasujja N, Rockwood K, Samus Q, Shirai K, Singh-Manoux A, Schneider LS, Walsh S, Yao Y, Sommerlad A, Mukadam N. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024 Aug 10;404(10452):572-628. doi: 10.1016/S0140-6736(24)01296-0. Epub 2024 Jul 31. No abstract available.

  PMID: 39096926 BACKGROUND

• Tagliabue CF, Guzzetti S, Gualco G, Boccolieri G, Boccolieri A, Smith S, Daini R. A group study on the effects of a short multi-domain cognitive training in healthy elderly Italian people. BMC Geriatr. 2018 Dec 27;18(1):321. doi: 10.1186/s12877-018-1014-x.

  PMID: 30587151 BACKGROUND

• Limongi F, Siviero P, Noale M, Gesmundo A, Crepaldi G, Maggi S; Dementia Registry Study Group. Prevalence and conversion to dementia of Mild Cognitive Impairment in an elderly Italian population. Aging Clin Exp Res. 2017 Jun;29(3):361-370. doi: 10.1007/s40520-017-0748-1. Epub 2017 Mar 28.

  PMID: 28353219 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sabrina Guzzetti

  Casa di Cura Igea, Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina Guzzetti Neuropsychologist

CONTACT

+390248593315; s.guzzetti@casadicurigea.it

Giulia Gilardone Neuropsychologist

CONTACT

g.gilardone@casadicurigea.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: April 8, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

IT (2)