Neurological Soft Signs in Neurodegenerative Dementias

Alzheimer Disease Clinical Trial

— DemeNSS  

Official title:

Neurological Soft Signs in Neurodegenerative Dementias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06354933
• Other study ID #: DemeNSS (3785)
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: February 1, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• Corticobasal Degeneration
• Dementia
• Dementia With Lewy Bodies
• Frontotemporal Dementia
• Lewy Body Disease
• Pick Disease of the Brain

Intervention

Diagnostic Test:
• Neurological Soft Signs
Neurological Soft Signs score according to the Heidelberg Manual

Locations

Country	Name	City	State
Italy	Fondazione IRCCS San Gerardo dei Tintori	Monza	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Association between NSS and Neuropsychiatric Inventory (NPI) scores	Correlation between NSS and NPI (range 0-144) (higher values indicate better correlation)	0 days (baseline)
Secondary	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)
Secondary	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)
Secondary	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