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

A legfontosabb adatok

Ki végzi
Casa di Cura IGEA
Hol
Olaszország1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
40 fő, tervezett
Kezdés
2026. febr. 16.
Várható befejezés
2027. máj.
A vizsgálat típusa
Beavatkozással járó, 2 csoport
A vizsgált kezelések
  • Multimodal Group Cognitive Rehabilitation Intervention
  • Active Control
A regiszteradat frissítve
2026. április 8.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for people aged 50 or older with mild cognitive impairment (MCI), meaning mild memory or thinking problems that are not dementia. They join with a close person who can report on them.

Életkor
50 Years and older
Nem
All
A betegség stádiuma
Mild cognitive impairment (MCI) diagnosed by the criteria of Petersen (2004) and Winblad et al. (2004). If the MCI is due to Alzheimer's disease, also by the criteria of Albert and colleagues (2011).
Korábbi kezelés
People cannot have other brain-skill (neuropsychological) rehabilitation during the study. People must agree to report changes in doses of medicines that may affect thinking.

A részvétel fő kizáró okai

  • Parkinson's disease, or MCI affecting only language (possible start of primary progressive aphasia)
  • Other brain conditions linked to thinking problems, such as a past stroke or head injury
  • Lab results linked to thinking problems, such as low vitamin B12 or folate, or thyroid problems
  • Primary psychiatric disorders, or alcohol or drug use disorder in the past 10 years
  • Severe behaviour problems, or hearing or sight problems that would get in the way of the group sessions or tests

A regiszter feltételei, szó szerint

Mind a 14 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • Other neurological conditions potentially associated with cognitive impairment (e.g., previous stroke or traumatic brain injury)
  • Alcohol or substance use disorder in the previous 10 years
  • Parkinson's disease
  • Primary psychiatric disorders
  • Medical conditions that may interfere with completion of the study
  • Significant laboratory abnormalities potentially associated with cognitive impairment (e.g., low levels of vitamin B12 or folate, or values indicative of thyroid disorders)
  • Linguistic single-domain MCI (suspected onset of primary progressive aphasia)
  • Severe behavioral disturbances limiting group participation
  • Hearing or visual impairments that may interfere with assessment or treatment
  • Exposure, during the study period, to other neuropsychological rehabilitation interventions
  • Patient's refusal to sign the informed consent

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • Multimodal Group Cognitive Rehabilitation InterventionA vizsgált kezelés

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

  • Active Control ConditionEgyéb csoport

    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.

    Kezelés: Active Control

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Sviluppo di un Intervento di Riabilitazione Cognitiva Applicabile e Sostenibile Nella Pratica Clinica Per i Pazienti Con Mild Cognitive Impairment
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
A regiszteradat frissítve
2026. április 8.