Neurological Soft Signs in Neurodegenerative Dementias

Completed

• Conditions: Frontotemporal Dementia; Corticobasal Degeneration; Alzheimer Disease; Dementia With Lewy Bodies
• Interventions: Diagnostic Test: Neurological Soft Signs

• Registration Number: NCT06354933
• Lead Sponsor: University of Milano Bicocca

Brief Summary

The goal of this observational study is to investigate the prevalence of Neurological Soft Signs (NSS) in various categories of dementia patients compared to matched controls. The main questions it aims to answer are:

* Does the prevalence of NSS significantly differ among patients with neurodegenerative dementias compared to controls?

* Are NSS associated with neuropsychiatric alterations in dementia patients?

* Do NSS correlate with cognitive screening tools?

* Do NSS increase over time in patients with neurodegenerative dementias?

Participants will undergo assessments including:

* Evaluation of NSS using the Heidelberg scale

* Neuropsychiatric assessments

* Cognitive screening using the Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB)

Researchers will compare dementia groups (Alzheimer's disease, Frontotemporal dementia, Corticobasal syndrome and Lewy body dementia) to controls to determine differences in NSS prevalence. Additionally, associations between NSS and neuropsychiatric symptoms, as well as cognitive performance, will be explored.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2023-11-30
• Study Completion: 2024-02-01
• Status Verified: 2024-03
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-09
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• Diagnosis of probable Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), Corticobasal Syndrome (CBS), or probable Lewy Body Dementia (LBD) according to established clinical criteria.
• MMSE score greater than 10.
• Age and gender-matched controls without a history of neurological or psychiatric conditions.

Exclusion Criteria

• Mixed dementia or vascular etiology.
• History of neurological or psychiatric conditions predating the dementia diagnosis.
• Substance or alcohol abuse history.
• Known comorbidities affecting neurological or psychiatric function.
• MMSE score less than or equal to 10.
• Inability to provide informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neurodegenerative dementias	Neurological Soft Signs	Subjects with either Alzheimer's disease, frontotemporal dementia, dementia with Lewy bodies or corticobasal syndrome
Control	Neurological Soft Signs	Subjects without dementia

Primary Outcome Measures

Name	Time	Method
Difference in NSS	0 days (baseline)	Difference in Neurological Soft Signs according to the Heidelberg manual between neurodegenerative dementias and controls (range 0-48, higher scores indicate worse performance)

Secondary Outcome Measures

Name	Time	Method
Correlation between NSS scores and cognitive function assessed by Frontal Assessment Battery (FAB)	0 days (baseline)	Correlation between NSS and FAB (range 0-18) (higher values indicate better correlation)
Longitudinal changes in NSS scores	12 months	Longitudinal differences in NSS scores in subjects with neurodegenerative dementia (range 0-48) (higher scores indicate worse performance)
Association between NSS and Neuropsychiatric Inventory (NPI) scores	0 days (baseline)	Correlation between NSS and NPI (range 0-144) (higher values indicate better correlation)
Correlation between NSS scores and cognitive function assessed by Mini-Mental State Examination (MMSE)	0 days (baseline)	Correlation between NSS and MMSE (range 0-30) (higher values indicate better correlation)

Trial Locations

Locations (1)

Fondazione IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, Lombardia, Italy