NCT06657274 · RECRUITING
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
This trial is testing a home-based digital cognitive training program called RICORDO-DTx against unstructured at-home mental stimulation, in people with mild cognitive impairment, subjective cognitive complaints, or Parkinson's disease. Researchers want to know whether the structured digital program improves cognition better than casual mental activity, and whether it changes biological and brain-activity markers. This is a Phase NA randomized controlled trial — meaning it is evaluating a behavioral and digital device intervention, not a drug.
You may qualify if
- 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
You're excluded if
- Presence of any medical or psychiatric illness that could interfere with completing assessments;
- Presence of any medical condition representing a contraindication to TMS.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-05-02