Neurological Soft Signs in Neurodegenerative Dementias (DemeNSS)

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Corticobasal Degeneration; Frontotemporal Dementia; Dementia With Lewy Bodies
• Intervention / Treatment: Diagnostic test: Neurological Soft Signs

• Study Type: Observational
• Enrollment (Actual): 186

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Monza, Lombardia, Italy, 20900
      • Fondazione IRCCS San Gerardo dei Tintori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study will include individuals diagnosed with Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), Corticobasal Syndrome (CBS), or Lewy Body Dementia (LBD), along with age and gender-matched controls without dementia. Controls will be recruited from caregivers and companions of patients attending other neurological clinics. All participants will undergo thorough neurological and neuropsychiatric assessments to confirm eligibility and evaluate outcomes.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neurodegenerative dementias; Subjects with either Alzheimer's disease, frontotemporal dementia, dementia with Lewy bodies or corticobasal syndrome	Diagnostic test: Neurological Soft Signs; Neurological Soft Signs score according to the Heidelberg Manual
Control; Subjects without dementia	Diagnostic test: Neurological Soft Signs; Neurological Soft Signs score according to the Heidelberg Manual

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Milano Bicocca
• Investigators: Principal Investigator: Lucio Tremolizzo, MD, PhD, University of Milano Bicocca

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Tauopathies; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Dementia; Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Corticobasal Degeneration
• Other Study ID Numbers: DemeNSS (3785)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No