NCT05815329 MASCoD - Multidimensional Assessment of Subjective Cognitive Decline
| NCT ID | NCT05815329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Cognitive Decline |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-08-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-08-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Subjective cognitive decline-SCD is a subclinical cognitive impairment subjectively experienced without being detectable from a diagnostic and neuropsychological perspective. It can negatively impact on patient's frailty and quality of life and it may be prodromal to severe cognitive impairment. Currently, only a few screening tools focusing mainly on memory complaints exist. The aim of this study is to analyze if a new screening tool called MASCoD (Multidimensional Assessment of Subjective Cognitive Decline) can detect and monitor the SCD, predicting the risk of developing severe cognitive decline over time. Specifically, the investigators have the following aims: primary objectives: 1. To assess the construct validity and tune the clinical cutoffs of the new instrument through the correlation of MASCoD scores with neuropsychological evaluation and brain 18F-FDG-PET. 2. To assess the clinical validity (predictive capability) of the new instrument through a classification model (dependent variable: brain 18F-FDG-PET examination; independent variable: MASCoD; control variables: gender, age and neuropsychological evaluation). Secondary objective: To evaluate the suitability of MASCoD as tool for the monitoring of patients over time. Specifically, the investigators want to evaluate if the MASCoD score is able to assess the effects of a cognitive treatment and, in turn, to identify outpatients who most likely will benefit from it. After the multidimensional evaluation at T0, the participants will be randomly allocated into an experimental group and a wait list control group. Specifically, cognitive training will be offered by means of technological devices (Neurotablet). At T1, all outpatients (experimental group and wait list control group) will be evaluated through MASCoD and the extensive neuropsychological evaluation for the second time.
Eligibility Criteria
Inclusion Criteria: * reported subjective cognitive decline without any other cognitive or neurological issue, * Italian education, * adult (\> 55 years old), * understanding of research aims, * signed informed consent, * participation on a voluntary and non-payied bases. Exclusion Criteria: * serious clinical conditions (e.g. severe cardiac and respiratory problems, neoplasia) * prior diagnosis of psychiatric disorders according to DSM-5, * prior diagnosis of cognitive decline, * relevant visuo-perceptive or hearing deficits, * illiteracy or relapse in illiteracy, * refusal to partake in the research.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05815329 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Cognitive Decline. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05815329 currently recruiting?
Yes, NCT05815329 is actively recruiting participants. Contact the research team at cira.fundaro@icsmaugeri.it for enrollment information.
Where is the NCT05815329 trial being conducted?
This trial is being conducted at Montescano, Italy.
Who is sponsoring the NCT05815329 clinical trial?
NCT05815329 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The trial plans to enroll 100 participants.