Clinical trial NCT06354933: Neurological Soft Signs in Neurodegenerative Dementias
Official title: Neurological Soft Signs in Neurodegenerative Dementias
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Dementia With Lewy Bodies
Frontotemporal Dementia
Corticobasal Degeneration
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in NSS
timeFrame: 0 days (baseline)
Secondary outcomes:
measure: Association between NSS and Neuropsychiatric Inventory (NPI) scores
timeFrame: 0 days (baseline)
measure: Correlation between NSS scores and cognitive function assessed by Mini-Mental State Examination (MMSE)
timeFrame: 0 days (baseline)
measure: Correlation between NSS scores and cognitive function assessed by Frontal Assessment Battery (FAB)
timeFrame: 0 days (baseline)
measure: Longitudinal changes in NSS scores
timeFrame: 12 months
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
state: Lombardia
Study officials:
affiliation: University of Milano Bicocca
name: Lucio Tremolizzo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: