EARLY-COGN^3 - Smart Digital Solutions for EARLY Treatment of COGnitive Disability: a Neuropsychological, Neurophysiological and Neurobiological Perspective in Chronic Neurological Diseases - PNRR-MCNT2-2023-12377069

Launched by IRCCS CENTRO SAN GIOVANNI DI DIO FATEBENEFRATELLI · Oct 23, 2024

Keywords

ClinConnect Summary

The EARLY-COGN^3 clinical trial is studying the effectiveness of a new home-based cognitive training program designed for people with Mild Cognitive Impairment (MCI), Subjective Cognitive Complaints (SCCs), and Parkinson's Disease (PD). This program uses technology to provide cognitive rehabilitation at home, which aims to help patients improve their memory and thinking skills in a comfortable environment. Participants will be randomly assigned to either the new cognitive training group or a control group that receives regular, unstructured mental activities. The trial also aims to understand how this new approach affects brain health and cognitive function over time.

To be eligible for the trial, participants must be aged between 18 and 85, speak Italian, and have a diagnosis of MCI, SCCs, or PD. They should have a certain level of cognitive ability and must not currently be undergoing any other rehabilitation programs. Participants can expect to receive support from a caregiver throughout the study and will need to agree to take part by signing a consent form. This trial is an important step in exploring how technology can enhance care for individuals facing cognitive challenges, especially as it may allow easier access to help for those living in remote areas or with mobility issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of PD (Hoehn \& Yahr\<3); MCI (with CDR scale≤0.5, MMSE ≥24), and SCC (Subjective Cognitive Complaints);
• • Montreal Cognitive Assessment (MoCA) corrected score ≥17.36
• • Education ≥ 5 years
• • Age eligible for the study: 18≤age≤85
• • Native Italian speakers
• • Absence of marked hearing/visual impairment
• • All of the subjects will have normal or corrected-to-normal vision.
• • Agreement to participate by signing the informed consent form
• • Availability of a caregiver/study partner able to support the participant
• • No rehabilitation program in place at the time of enrolment or in the last 3 months before enrolment
• • Stable drug treatment (last 3 months), if any
• Exclusion Criteria:
• • Presence of any medical or psychiatric illness that could interfere with completing assessments;
• • Presence of any medical condition representing a contraindication to TMS.