MASCoD - Multidimensional Assessment of Subjective Cognitive Decline

NCT05815329 | Recruiting

• 1 other identifier: 2666
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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. 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).

Conditions

Cognitive Decline

Keywords

mild cognitive impairment; subjective cognitive decline; neuropsychological rehabilitation

Outcome Measures

Primary Outcomes (1)

• instrument validation

  To assess the construct and clinical validity, and tune the clinical cutoffs of the new instrument MASCoD

  baseline

Secondary Outcomes (1)

• screening for rehabilitation suitability

  immediately after the cognitive training

Study Arms (2)

rehabilitation group

EXPERIMENTAL

Outpatients undergoing neurorehabilitation through Neurotablet

Other: cognitive training

waiting list

NO INTERVENTION

Outpatients not undergoing rehabilitation during the study. They will have the possibility to carry on the rehabilitation at the end of the study

Interventions

cognitive training OTHER

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 to half of the outpatients included in this research by means of technological devices (Neurotablet). A neuropsychologist will supervise the cognitive training offline (about 30 minutes per 5 days, 8 weeks) and through a face-to-face 1 hour-session each week per each outpatient.

rehabilitation group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

ICS Maugeri Montescano Institute

Montescano, Pavia, 27040, Italy

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Cira Fundarò, Neurologist

CONTACT

0385247268; cira.fundaro@icsmaugeri.it

Marina Maffoni, Psychologist

CONTACT

0385247212; marina.maffoni@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised controlled clinical study with follow up (experimental group and waiting list)

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 18, 2023
• Study Start: August 2, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-04

Locations

IT (1)