MASCoD - Multidimensional Assessment of Subjective Cognitive Decline

Recruiting now · Not applicable

Conditions studied: Cognitive Decline

In brief

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.

Key facts

Study ID

NCT05815329

Run by

Istituti Clinici Scientifici Maugeri SpA

People needed

100

Starts

2022-08-02

Expected to finish

2026-12-31

Last updated by the study team

2025-05-08

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ICS Maugeri Montescano Institute — Montescano, Pavia, Italy (enrolling)

Full record on ClinicalTrials.gov

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