Skip to main content
OpenTrials
Completed

NCT Number: NCT06354933

Neurological Soft Signs in Neurodegenerative Dementias

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Corticobasal Degeneration Dementia Dementia With Lewy Bodies Frontotemporal Dementia Frontotemporal Lobar Degeneration Lewy Body Disease Mental Disorders Metabolic Diseases Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinsonian Disorders Proteostasis Deficiencies Synucleinopathies TDP-43 Proteinopathies Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, 20900, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurological Soft Signs

Diagnostic Test

Neurological Soft Signs score according to the Heidelberg Manual

Primary outcomes

  1. Difference in NSS

    Time frame: 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 outcomes

  1. Association between NSS and Neuropsychiatric Inventory (NPI) scores

    Time frame: 0 days (baseline)

    Correlation between NSS and NPI (range 0-144) (higher values indicate better correlation)

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

    Time frame: 0 days (baseline)

    Correlation between NSS and MMSE (range 0-30) (higher values indicate better correlation)

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

    Time frame: 0 days (baseline)

    Correlation between NSS and FAB (range 0-18) (higher values indicate better correlation)

  4. Longitudinal changes in NSS scores

    Time frame: 12 months

    Longitudinal differences in NSS scores in subjects with neurodegenerative dementia (range 0-48) (higher scores indicate worse performance)

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Acronym: DemeNSS

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 9, 2024
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.