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New treatment option for Mild Cognitive Impairment (MCI)
Official title Personalized Digital Training for COGnitive FITness in Mild Cognitive Impairment
ClinicalTrials.gov ID: NCT07286448
What this study is testing
- What it's testing
- The goal of this clinical trial is to determine whether a home-based digital cognitive-training program called RICORDO can enhance patients' ability to manage their own health and daily life when they have Mild Cognitive Impairment (MCI) or Subjective Cognitive Decline (SCD) and are 50 years of age or older. The main questions it aims to answer are: Does using RICORDO for five weeks raise the Patient Activation Measure (PAM) score more than an at-home paper-and-video education program called S.A.M.B.A.?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Diagnosis of Mild Cognitive Impairment (MCI) based on Petersen (1999) and Winblad (2004), or Subjective Cognitive Decline (SCD) according to Jessen...
- Mini-Mental State Examination (MMSE) \> 18 and Clinical Dementia Rating (CDR) ≤ 1
- Age ≥ 50 years
- Formal education \> 3 years
- Signed informed consent
You likely can't join if
- Severe sensory or communication impairments
- Recent participation (\< 3 months) in cognitive or rehabilitation programs
- Failure to provide or withdrawal of informed consent
- History or evidence of central nervous system disorders that may affect cognition and are unrelated to the study (e.g., major stroke, brain tumors...
- History or evidence of major psychiatric disorders
- Presence of medical conditions that may interfere with cognitive function (e.g., renal or hepatic failure, obstructive sleep apnea, hypothyroidism...
See the full eligibility criteria
- Diagnosis of Mild Cognitive Impairment (MCI) based on Petersen (1999) and Winblad (2004), or Subjective Cognitive Decline (SCD) according to Jessen (2014)
- Mini-Mental State Examination (MMSE) \> 18 and Clinical Dementia Rating (CDR) ≤ 1
- Age ≥ 50 years
- Formal education \> 3 years
- Signed informed consent
- Stable neurotropic pharmacological therapy in the past 3 months (if applicable)
- Preserved mental capacity (i.e., not under legal guardianship or protective supervision)
- Preserved ability to understand and produce written and spoken Italian
- Severe sensory or communication impairments
- Recent participation (\< 3 months) in cognitive or rehabilitation programs
- Failure to provide or withdrawal of informed consent
- History or evidence of central nervous system disorders that may affect cognition and are unrelated to the study (e.g., major stroke, brain tumors, normal pressure hydrocephalus, traumatic brain injury)
- History or evidence of major psychiatric disorders
- Presence of medical conditions that may interfere with cognitive function (e.g., renal or hepatic failure, obstructive sleep apnea, hypothyroidism, vitamin B12 deficiency)
The study team makes the final eligibility decision.
Where it's taking place
- Modena, Reggio Nell'Emilia (RE), Italy
- Milan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Modena, Reggio Nell'Emilia (RE), Italy; Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.