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Neurological Soft Signs in Neurodegenerative Dementias

Neurological Soft Signs in Neurodegenerative Dementias

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06354933
Acronym
DemeNSS
Enrollment
186
Registered
2024-04-09
Start date
2022-04-01
Completion date
2024-02-01
Last updated
2026-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTNeurological Soft Signs

Neurological Soft Signs score according to the Heidelberg Manual

Sponsors

University of Milano Bicocca
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference in NSS0 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

MeasureTime frameDescription
Association between NSS and Neuropsychiatric Inventory (NPI) scores0 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)
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 scores12 monthsLongitudinal differences in NSS scores in subjects with neurodegenerative dementia (range 0-48) (higher scores indicate worse performance)

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORLucio Tremolizzo, MD, PhD

University of Milano Bicocca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026