Alzheimer s DiseaseTHE-Spoke 10NCT07259499
Predictors of Emergency Department Use in Frail Patients
An observational study of Alzheimer s Disease and Vascular Dementia, run by University of Pisa at 1 site in Italy.
Trial summary
When admitted to the emergency department (ED), elderly non-autonomous patients show high risk of adverse health outcomes. The prompt identification of ED use risk factors in such population is hence needed. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer s Disease, Vascular Dementia, Frailty
- What is being tested?
- Plasma phosphorylated Tau 181
- How many people
- 110 participants
- Where
- 1 siteItaly
- Study dates
- 19 Nov 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Adults fulfilling the inclusion criteria consecutively recruited during their outpatient visits at the Neurology and Geriatrics Units of the Pisa University Hospital (Italy).
Who may be able to join
- fluency in Italian language,
- age higher than 64 years,
- loss of autonomies of daily living as assessed by the Katz Activities of Daily Living or in the Lawton Instrumental Activities of Daily Living questionnaires,
- having performed routinary blood exams in the 6 months prior to recruitment
- having performed head neuroimaging feasable for cerebrovascular burden assessment, i.e., Magnetic Resonance Imaging (MRI) or computed tomography (CT), in the 6 months prior to recruitment.
Who cannot join
- withdrawal of the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Pisana
Pisa, Pisa, 56126
Benedetta Becherini, M.A., +39-050996418, clinicaltrial.center@ao-pisa.toscana.it
About this study
Official title: Towards an Integrated Care System for the Assistance of Patients With Chronic Diseases, Multimorbidity, Frailty, and Polypharmacy
When admitted to the emergency department (ED), elderly non-autonomous patients show high risk of adverse health outcomes. The prompt identification of ED use risk factors in such population is hence needed. While cognitive impairment is a known clinical risk factor, biomarkers of most prevalent dementias have been scarcely investigated as possible ED use predictors. Within this context, this prospective study aims at exploring whether plasma phospho-tau181 and cerebrovascular burden can predict ED use at 6 months in elderly non-autonomous patients, irrespective of frailty.
Read the detailed description
When admitted to the emergency department (ED), elderly non-autonomous patients show high risk of mortality, extended hospital stays and early readmission after discharge. The prompt identification of ED use risk factors in such population is hence urgently needed. Among these, cognitive impairment emerged as a key neurologic risk factor of ED use.
Alzheimer's Disease (AD) and cerebrovascular damage are the first cause of cognitive impairment in the general population. Several biomarkers have been proposed to distinguish different types of dementia during clinical practice. Considering AD, plasma phosphorylated tau 181 protein (ptau181) recently emerged as a biomarker which accurately predicts cerebrospinal ptau181 levels. Moreover, based on this evidence and on its minimally invasive nature, plasma ptau181 has been recently proposed as a biomarker to be employed during the AD diagnostic process, along with previously recommended procedures. Of note, plasma pTau181 levels are positively associated to confusional state risk in hospitalized patients. In parallel, cerebrovascular burden is commonly assessed in available neuroimages during the clinical characterization of cognitive impairments, and its severity has been associated to the severity of cognitive impairment. Within this context, no studies explored biomarkers of AD and vascular dementia as possible risk factors for ED use. Confirming such predictive value may result highly useful in stratifying the patients' risk of future adverse health outcomes during clinical practice.
Of note, non-autonomous elderly patients often suffer from multiple health problems. Such health problems concur to define patients' frailty, with higher frailty levels being associated with increased rates of adverse health outcomes, included ED use and mortality. Due to the multidimensional nature of frailty, several assessment methods have been developed. Specifically, recent literature proposed the use of multidimensional frailty indexes including relatively extended sets of variables available in public health databases. Among these, routinary assessed blood biomarkers and scales characterizing frailty from different clinical standpoints, e.g., nutritional status, autonomies of daily living, lower limb functionality, have been included. Demonstrating a relationship between biomarkers of cognitive impairment and ED use irrespective of patients' multidimensional frailty would highlight the importance of the neurological evaluation within the clinical assessment of non-autonomous elderly patients.
Within this context, the present study aims at investigating whether plasma ptau181 and cerebrovascular burden can predict ED use in non-autonomous elderly patients within a relatively short observational period, irrespective of multidimensional clinical frailty.
- Conditions
- Alzheimer s Disease, Vascular Dementia, Frailty, Elderly, Emergency Department Visits, Autonomy
- Being tested
- Plasma phosphorylated Tau 181
- Keywords
- phosphorylated tau 181, dementia, Emergency Department, Frailty, Autonomies, Elderly, cerebrovascular
- Medical subject headings
- Dementia, Vascular, Frailty, Dementia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma phosphorylated Tau 181Diagnostic test
Plasma will be collected in dipotassium EDTA tubes at recruitment and centrifugated at 1800-2000xg for 10 minutes within a short data frame. Plasma will be subsequently aliquoted and stored at -80°C. Immediately prior to analysis, samples will be thawed at room temperature, vortexed, and centrifuged. Plasma p-tau181 concentrations will be then quantified using a fully automated chemiluminescent enzyme immunoassay on the LUMIPULSE G600II system, in accordance with the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Elderly, non-autonomous Patients | Adult participants fulfilling the following inclusion criteria: fluency in Italian language, age higher than 64 years, loss of autonomies of daily living as assessed by the Katz Activities of Daily Living or in the Lawton Instrumental Activities of Daily Living questionnaires, having performed blood exams and a head neuroimaging feasable for cerebrovascular burden assessment, i.e., Magnetic Resonance Imaging (MRI) or computed tomography (CT), in the 6 months prior to recruitment. Receives: Diagnostic Test: Plasma phosphorylated Tau 181 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department Use
The patient visits an emergency department (ED). The proportion of participants visiting the ED will be assessed at the end of the observational period.
Biomarkers of cognitive impairment, i.e., plasma phosphorylated tau 181 and cerbrovascular burden, will be subsequently tested as possible predictors of this outcome.
Measured: Within 6 months from recruitment
Secondary outcomes (1)
Time to emergency department use
The difference in days between the emergency department (ED) use and the recruitment date.
The mean time to emergency department use will be assessed in ED users at the end of the observational period.
Biomarkers of cognitive impairment, i.e., plasma phosphorylated tau 181 and cerbrovascular burden, will be subsequently tested as possible predictors of this outcome.
Measured: Within 6 months from recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start19 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s 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 only
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana
- Responsible party
- Principal investigator, Gabriele Siciliano, University of Pisa
- Investigators
- Gabriele Siciliano, Professor, MD, PhD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259499
- Sponsor's protocol ID
- 25312_SICILIANO
- Acronym
- THE-Spoke 10
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards an Integrated Care System for the Assistance of Patients With Chronic Diseases, Multimorbidity, Frailty, and Polypharmacy
- ClinicalTrials.gov ID
- NCT07259499
- Acronym / sponsor ID
- THE-Spoke 10 / 25312_SICILIANO
- Conditions
- Alzheimer s Disease, Vascular Dementia, Frailty, Elderly, Emergency Department Visits, Autonomy
- Keywords
- phosphorylated tau 181, dementia, Emergency Department, Frailty, Autonomies, Elderly, cerebrovascular
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana
- Study start
- 19 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Dec 2025 (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.
When admitted to the emergency department (ED), elderly non-autonomous patients show high risk of adverse health outcomes. The prompt identification of ED use risk factors in such population is hence needed. While cognitive impairment is a known clinical risk factor, biomarkers of most prevalent dementias have been scarcely investigated as possible ED use predictors. Within this context, this prospective study aims at exploring whether plasma phospho-tau181 and cerebrovascular burden can predict ED use at 6 months in elderly non-autonomous patients, irrespective of frailty.
Detailed description
When admitted to the emergency department (ED), elderly non-autonomous patients show high risk of mortality, extended hospital stays and early readmission after discharge. The prompt identification of ED use risk factors in such population is hence urgently needed. Among these, cognitive impairment emerged as a key neurologic risk factor of ED use.
Alzheimer's Disease (AD) and cerebrovascular damage are the first cause of cognitive impairment in the general population. Several biomarkers have been proposed to distinguish different types of dementia during clinical practice. Considering AD, plasma phosphorylated tau 181 protein (ptau181) recently emerged as a biomarker which accurately predicts cerebrospinal ptau181 levels. Moreover, based on this evidence and on its minimally invasive nature, plasma ptau181 has been recently proposed as a biomarker to be employed during the AD diagnostic process, along with previously recommended procedures. Of note, plasma pTau181 levels are positively associated to confusional state risk in hospitalized patients. In parallel, cerebrovascular burden is commonly assessed in available neuroimages during the clinical characterization of cognitive impairments, and its severity has been associated to the severity of cognitive impairment. Within this context, no studies explored biomarkers of AD and vascular dementia as possible risk factors for ED use. Confirming such predictive value may result highly useful in stratifying the patients' risk of future adverse health outcomes during clinical practice.
Of note, non-autonomous elderly patients often suffer from multiple health problems. Such health problems concur to define patients' frailty, with higher frailty levels being associated with increased rates of adverse health outcomes, included ED use and mortality. Due to the multidimensional nature of frailty, several assessment methods have been developed. Specifically, recent literature proposed the use of multidimensional frailty indexes including relatively extended sets of variables available in public health databases. Among these, routinary assessed blood biomarkers and scales characterizing frailty from different clinical standpoints, e.g., nutritional status, autonomies of daily living, lower limb functionality, have been included. Demonstrating a relationship between biomarkers of cognitive impairment and ED use irrespective of patients' multidimensional frailty would highlight the importance of the neurological evaluation within the clinical assessment of non-autonomous elderly patients.
Within this context, the present study aims at investigating whether plasma ptau181 and cerebrovascular burden can predict ED use in non-autonomous elderly patients within a relatively short observational period, irrespective of multidimensional clinical frailty.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly, non-autonomous Patients | – | Diagnostic Test: Plasma phosphorylated Tau 181Adult participants fulfilling the following inclusion criteria: fluency in Italian language, age higher than 64 years, loss of autonomies of daily living as assessed by the Katz Activities of Daily Living or in the Lawton Instrumental Activities of Daily Living questionnaires, having performed blood exams and a head neuroimaging feasable for cerebrovascular burden assessment, i.e., Magnetic Resonance Imaging (MRI) or computed tomography (CT), in the 6 months prior to recruitment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adults fulfilling the inclusion criteria consecutively recruited during their outpatient visits at the Neurology and Geriatrics Units of the Pisa University Hospital (Italy).
Key inclusion criteria (5 listed)
- fluency in Italian language,
- age higher than 64 years,
- loss of autonomies of daily living as assessed by the Katz Activities of Daily Living or in the Lawton Instrumental Activities of Daily Living questionnaires,
- having performed routinary blood exams in the 6 months prior to recruitment
- having performed head neuroimaging feasable for cerebrovascular burden assessment, i.e., Magnetic Resonance Imaging (MRI) or computed tomography (CT), in the 6 months prior to recruitment.
Key exclusion criteria (1 listed)
- withdrawal of the informed consent
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 |
|---|---|---|
| Plasma phosphorylated Tau 181Plasma will be collected in dipotassium EDTA tubes at recruitment and centrifugated at 1800-2000xg for 10 minutes within a short data frame. Plasma will be subsequently aliquoted and stored at -80°C. Immediately prior to analysis, samples will be thawed at room temperature, vortexed, and centrifuged. Plasma p-tau181 concentrations will be then quantified using a fully automated chemiluminescent enzyme immunoassay on the LUMIPULSE G600II system, in accordance with the manufacturer's instructions. | Diagnostic test | Elderly, non-autonomous Patients |
Primary outcome
Emergency Department Use
Time frame: Within 6 months from recruitment
The patient visits an emergency department (ED). The proportion of participants visiting the ED will be assessed at the end of the observational period. Biomarkers of cognitive impairment, i.e., plasma phosphorylated tau 181 and cerbrovascular burden, will be subsequently tested as possible predictors of this outcome.
1 secondary outcome
Time to emergency department use
Time frame: Within 6 months from recruitment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication.
Related trials for Alzheimer s Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Not yet recruitingObservational study
Chinese University-Alzheimer's Disease With Vascular and Other Co-pathology: Towards Actionable Neuro-Cognitive-Omic Evaluations (CU-ADVANCE)
Alzheimer s Disease, Mild Cognitive Impairment (MCI)
RecruitingObservational study
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
Stroke, Alzheimer s Disease
RecruitingPhase 1
An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease
Alzheimer s Disease
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.
Gabriele Siciliano, Professor, MD, PhD principal investigator
University of Pisa
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 s Disease and Vascular Dementia, run by University of Pisa 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Turco, MD, PhD (+39-050992905, francesco.turco@phd.unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Department Use (time frame: Within 6 months from recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.