Neurological Soft Signs in Neurodegenerative Dementias

NCT06354933 | Completed

• 1 other identifier: DemeNSS (3785)
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Dementia With Lewy Bodies; Frontotemporal Dementia; Corticobasal Degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Association between NSS and Neuropsychiatric Inventory (NPI) scores

  0 days (baseline)

• Correlation between NSS scores and cognitive function assessed by Mini-Mental State Examination (MMSE)

  0 days (baseline)

• Correlation between NSS scores and cognitive function assessed by Frontal Assessment Battery (FAB)

  0 days (baseline)

• Longitudinal changes in NSS scores

  12 months

Study Arms (2)

Neurodegenerative dementias

Subjects with either Alzheimer's disease, frontotemporal dementia, dementia with Lewy bodies or corticobasal syndrome

Diagnostic Test: Neurological Soft Signs

Control

Subjects without dementia

Diagnostic Test: Neurological Soft Signs

Interventions

Neurological Soft Signs DIAGNOSTIC_TEST

Neurological Soft Signs score according to the Heidelberg Manual

Control; Neurodegenerative dementias

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, 20900, Italy

Location

Related Publications (1)

• Pozzi FE, Falco A, Gotti G, Fiamingo G, Remoli G, Appollonio I, Ferrarese C, Tremolizzo L. Neurological soft signs in neurodegenerative dementias: Results of the DemeNSS study. PCN Rep. 2025 Jun 25;4(2):e70143. doi: 10.1002/pcn5.70143. eCollection 2025 Jun.

  PMID: 40567948 RESULT

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia; Corticobasal Degeneration

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lucio Tremolizzo, MD, PhD

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: April 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: February 1, 2024
• Last Updated: March 25, 2026

Record last verified: 2024-03

Locations

IT (1)