Dementia and Mild Cognitive Impairment: Assessment of Cognitive Functioning, Functional Autonomy, and Neuropsychiatric Symptoms.

NCT07287410 | Recruiting DMC

• 1 other identifier: 20/2025
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

Dementia, in its various forms, is characterized by a generalized cognitive decline that can significantly compromise personal autonomy and quality of life. Mild Cognitive Impairment (MCI), although not classified as an overt form of dementia, represents a condition at evolutionary risk and is considered a crucial transitional stage for the early detection of cognitive decline. Understanding the impact of dementia and MCI from a multidimensional perspective is now essential to fully grasp the repercussions of these conditions on patients' daily lives. The present protocol aims to investigate key aspects related to these disorders, with the objective of exploring cognitive functioning, the degree of impairment in activities of daily living, and the presence of neuropsychiatric symptoms. Through an integrated and multidisciplinary approach, the study seeks to enhance clinical management and patient care, promoting more effective, targeted, and personalized interventions.

Conditions

Dementia; Mild Cognitive Impairment (MCI)

Keywords

Dementia; Mild Cognitive Impairment; neuropsychological; Activities of Daily Living; Neuropsychiatric symptoms

Outcome Measures

Primary Outcomes (1)

• Dementia or Mild Cognitive Impairment (MCI) with ADL

  The primary outcome variable considered for calculation is the score of the Activities of Daily Living (ADL) scale, used as the main index of functional autonomy in subjects with dementia or mild cognitive impairment (MCI).

  12 MONTHS

Secondary Outcomes (1)

• Functional autonomy in instrumental activities measured with the Instrumental Activities of Daily Living (IADL) scale

  12 MONTHS

Interventions

none - observational study OTHER

none - observational study

Eligibility Criteria

• Age: 50 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

151

You may qualify if:

• Age between 50 and 86 years.
• Suspected or confirmed diagnosis of dementia or mild cognitive impairment (MCI).
• Referral to the neuropsychology clinic for initial assessment or clinical monitoring.
• Absence of behavioral, psychiatric, or sensory disorders severe enough to significantly impair cognitive testing or completion of questionnaires.

You may not qualify if:

• Presence of neurological disorders other than dementia or MCI (e.g., recent stroke, severe traumatic brain injury, epilepsy, multiple sclerosis, atypical neurodegenerative diseases).
• Unstable major psychiatric comorbidities at the time of assessment (e.g., schizophrenia, bipolar disorder in active phase, untreated severe depression).
• Uncorrected severe sensory deficits (visual or auditory) affecting the validity of cognitive or functional assessments.
• Use of medications with significant cognitive impact (e.g., sedatives, high-dose antipsychotics) not stabilized at the time of evaluation.
• Presence of terminal medical or oncological conditions or other illnesses significantly interfering with the assessment procedures.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

Irccs Centro Neurolesi Bonino Pulejo

Messina, ME, 98123, Italy

RECRUITING

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Central Study Contacts

Francesco Corallo

CONTACT

09060128335; francesco.corallo@irccsme.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychological manager

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 17, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)