Neurological Soft Signs in Neurodegenerative Dementias (DemeNSS)

March 23, 2026 updated by: University of Milano Bicocca

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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)
0 days (baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0 days (baseline)
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)
0 days (baseline)
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)
0 days (baseline)
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)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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