Neurological Soft Signs in Neurodegenerative Dementias

NCT ID: NCT06354933

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease Dementia With Lewy Bodies Frontotemporal Dementia Corticobasal Degeneration

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Neurodegenerative dementias

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

Neurological Soft Signs

Intervention Type DIAGNOSTIC_TEST

Neurological Soft Signs score according to the Heidelberg Manual

Control

Subjects without dementia

Neurological Soft Signs

Intervention Type DIAGNOSTIC_TEST

Neurological Soft Signs score according to the Heidelberg Manual

Interventions

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Neurological Soft Signs

Neurological Soft Signs score according to the Heidelberg Manual

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Milano Bicocca

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lucio Tremolizzo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Milano Bicocca

Locations

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Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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DemeNSS (3785)

Identifier Type: -

Identifier Source: org_study_id

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