Alzheimer DiseaseDemeNSSNCT06354933
Neurological Soft Signs in Neurodegenerative Dementias
An observational study of Alzheimer Disease and Dementia With Lewy Bodies, run by University of Milano Bicocca at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia With Lewy Bodies, Frontotemporal Dementia
- What is being tested?
- Neurological Soft Signs
- How many people
- 186 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
- Conditions
- Alzheimer Disease, Dementia With Lewy Bodies, Frontotemporal Dementia, Corticobasal Degeneration
- Being tested
- Neurological Soft Signs
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease, Frontotemporal Dementia, Corticobasal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological Soft SignsDiagnostic test
Neurological Soft Signs score according to the Heidelberg Manual
| Study group | Role | What they receive |
|---|---|---|
| Neurodegenerative dementias | Subjects with either Alzheimer's disease, frontotemporal dementia, dementia with Lewy bodies or corticobasal syndrome Receives: Diagnostic Test: Neurological Soft Signs | |
| Control | Subjects without dementia Receives: Diagnostic Test: Neurological Soft Signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0 days (baseline)
Secondary outcomes (4)
Association between NSS and Neuropsychiatric Inventory (NPI) scores
Correlation between NSS and NPI (range 0-144) (higher values indicate better correlation)
Measured: 0 days (baseline)
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)
Measured: 0 days (baseline)
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)
Measured: 0 days (baseline)
Longitudinal changes in NSS scores
Longitudinal differences in NSS scores in subjects with neurodegenerative dementia (range 0-48) (higher scores indicate worse performance)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Apr 2022
- Primary completion30 Nov 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucio Tremolizzo, MD, PhD, Principal investigator, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354933
- Sponsor's protocol ID
- DemeNSS (3785)
- Acronym
- DemeNSS
- Status last verified
- Mar 2024
- First submitted
- 3 Apr 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pozzi FE, Falco A, Gotti G, Fiamingo G, Remoli G, Appollonio I, Ferrarese C, Tremolizzo L. Neurological soft signs in neurodegenerative dementias: Results of the DemeNSS study. PCN Rep. 2025 Jun 25;4(2):e70143. doi: 10.1002/pcn5.70143. eCollection 2025 Jun.
PubMed 40567948
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Soft Signs in Neurodegenerative Dementias
- ClinicalTrials.gov ID
- NCT06354933
- Acronym / sponsor ID
- DemeNSS / DemeNSS (3785)
- Conditions
- Alzheimer Disease, Dementia With Lewy Bodies, Frontotemporal Dementia, Corticobasal Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurodegenerative dementias | – | Diagnostic Test: Neurological Soft SignsSubjects with either Alzheimer's disease, frontotemporal dementia, dementia with Lewy bodies or corticobasal syndrome |
| Control | – | Diagnostic Test: Neurological Soft SignsSubjects without dementia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurological Soft SignsNeurological Soft Signs score according to the Heidelberg Manual | Diagnostic test | Control, Neurodegenerative dementias |
Primary outcome
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)
4 secondary outcomes
Association between NSS and Neuropsychiatric Inventory (NPI) scores
Time frame: 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 scores and cognitive function assessed by Frontal Assessment Battery (FAB)
Time frame: 0 days (baseline)
Longitudinal changes in NSS scores
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Results publication: PubMed 40567948Pozzi FE, Falco A, Gotti G, Fiamingo G, Remoli G, Appollonio I, Ferrarese C, Tremolizzo L. Neurological soft signs in neurodegenerative dementias: Results of the DemeNSS study. PCN Rep. 2025 Jun 25;4(2):e70143. doi: 10.1002/pcn5.70143. eCollection 2025 Jun.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucio Tremolizzo, MD, PhD principal investigator
University of Milano Bicocca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia With Lewy Bodies, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in NSS (time frame: 0 days (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06354933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.