Alzheimer's DiseasePERSON-ALNCT04820127
Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease: Impact on Health Resources Use
A study testing personalized care preceded by a standardized assessment in people with Alzheimer's Disease, run by University Hospital, Toulouse at 15 sites in France.
Trial summary
The present project propose to study the effectiveness of a personalized care management of psycho-behavioral symptoms based on an evidence-based standardized assessment to identify and understand the underlying causes of psycho-behavioral symptoms followed by a personalized intervention based on targeted and… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- personalized care preceded by a standardized assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 15 sitesFrance
- Study dates
- 14 Oct 2021to 28 Apr 2026
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For the patient :
- Diagnosed with major neuro-cognitive disorders (DSM V) at all severity stages.
- Leaving at home
- Assisted by a caregiver, from patient's family or personal environment, assuming most of patient care (spending at least 6 hours per week with the patient)
- caregiver available to come with the patient to study visits as planned per protocol
- existing agitation since at least one month (according to International Psychogeriatric Association (IPA) criteria)
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- agitation severity ≥ 2 , based on Clinician Global Impression of Severity (CGI-S) (at least mild severity)
- the patient, his/her family member/trusted person , or his /her legal responsible has provided written informed consent to participate in the study
- referring physician's oral approval obtained for patient participation in the study
- Affiliated to French Healthcare System
- For the caregiver:
- Has provided his/her written informed consent to participate in the study
- Ability to understand and speak French properly, ability to complete the questionnaires and assess the patient.
- Affiliated to French Healthcare System
Who cannot join
- For the patient:
- Agitation symptoms attributable either to other concomitant prescriptions, or to other psychiatric or evolving somatic diseases.
- Patient living in a residential care facility or having an institutionalization project within 6 months
- Patient with clinically significant or unstable disease that could affect he/her ability to come for the study visit or complete the evaluations planned as per protocol
- Concomitant participation to any other interventional research study
- Patient under legal protection.
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- For the caregiver:
- Caregiver under legal protection.
- Limited internet access or caregiver feeling unable to use it
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CH d'Albi
Albi
CH de Cahors
Cahors
Carcassonne Hospital
Carcassonne, 11000
CHI Castres Mazamet
Castres
CH Lannemezan
Lannemezan
CH Lavaur
Lavaur
Limoges university hospital
Limoges
Lyon University Hospital
Lyon
CH Montauban
Montauban
Perpignan Hospital
Perpignan
CHI Val d'Ariège
Saint-Girons
Toulouse University Hospital (CHU de Toulouse)
Toulouse, 31059
University Hospital Toulouse - Neurology department
Toulouse, 31059
CH de Bigorre
Vic-en-Bigorre
HNO-Franche-sur-Soâne
Villefranche-sur-Saône
About this study
Official title: Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease and Related Disorders: Impact on Health Resources Use
The present project propose to study the effectiveness of a personalized care management of psycho-behavioral symptoms based on an evidence-based standardized assessment to identify and understand the underlying causes of psycho-behavioral symptoms followed by a personalized intervention based on targeted and prioritized actions. This personalized intervention is proposed both to Alzheimer disease (AD) patients living at home with agitation-type psycho-behavioral symptoms, and also to their caregivers with the support and coordination of a nurse working in collaboration with the specialist physician and the General Practitioner (GP). News technologies are used to enhance the follow-up, based on telehealth, and caregiver training.
The project hypothesize that, for a vulnerable population at risk (AD patient with agitation and their caregivers) living at home, a personalized intervention, carried out and coordinated by a nurse in close collaboration with the specialist and GP, would reduce hospitalizations and have a positive effect on the disease evolution and caregiver distress. Also this personalized intervention could reduce the cost of care, in particular by reducing the costs associated with hospitalizations and informal help.
Read the detailed description
PERSON-AL is a multicentric, interventional, open-label, randomized, parallel-group, stratified by centre, study comparing two arms: usual care versus intervention (personalized care preceded by a standardized assessment)
Principal Objective : To evaluate the impact of a personalized intervention for the management of agitation due to psycho-behavioral symptoms on the use of scheduled and unscheduled hospitalizations at 18 months in patients with AD and related disorders.
Secondary Objectives:
A- To evaluate the impact of a personalized intervention at 18 months on:
For the patient:
- Unscheduled hospitalizations,
- Severity of agitation symptoms,
- The frequency and severity of emerging psycho-behavioral symptoms, other than agitation,
- Prescription of psychotropic drugs,
- Quality of life. For the caregiver:
- Distress related to psycho-behavioral symptoms,
- All causes hospitalizations,
- Quality of life.
B- Evaluate the medico-economic impact of this personalized intervention, and in particular:
- Its efficiency compared to usual management by means of cost-effectiveness and cost-utility analyses, from the community perspective and over a time horizon of 18 months,
- The actual cost of patient's standardized assessment and personalized management
- The use of care and associated costs for the caregiver and the efficiency of caregiver targeted intervention.
- Conditions
- Alzheimer's Disease
- Being tested
- personalized care preceded by a standardized assessment
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized care preceded by a standardized assessmentBehavioural
- personalized intervention plan (PIP) proposed to the patient/caregiver dyad to correct potentially reversible causes of psycho-behavioral symptoms. This PIP will be re-evaluated and adapted at each visit by the nurse in close collaboration with the GP;
- PIP implementation will be based on a close follow-up during the 18 months follow-up coordinated by the nurse (3 memory consultation visits, 3 home visits (with the GP) and 6 phone calls). This follow up will be enhanced with the use of a web platform (allowing teleconsultation, tele-expertise and telemonitoring);
- specific training on psycho-behavioral symptoms for caregivers at baseline and during follow-up will be performed. On line training on psycho-behavioral symptoms management for GP will be available;
| Study group | Role | What they receive |
|---|---|---|
| Control (usual care) | No intervention | Patients in the control group will benefit from the usual care with a half-yearly visit by the specialist physician (geriatrician, neurologist or psychiatrist) according to AD French national management guidelines (HAS 2011 and HAS 2018). |
| Intervention (personalized care program) | Experimental | Patients in the intervention group will benefit from personalized care preceded by a standardized assessment Receives: Behavioral: personalized care preceded by a standardized assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient's number of hospitalization at 18 months
number of all causes hospitalization, either scheduled or unscheduled, including emergency department visits
Measured: From the inclusion until End of Study, 18 months
Secondary outcomes (1)
patient's unscheduled hospitalization
all causes hospitalization, unscheduled, including emergency department visits
Measured: From the inclusion until End of Study, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start14 Oct 2021
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
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.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria SOTO, MD, Principal investigator, University Hospital Toulouse - Gerontopole
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820127
- Sponsor's protocol ID
- RC31/19/0555
- Acronym
- PERSON-AL
- Status last verified
- May 2026
- First submitted
- 24 Dec 2020
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Management of Psycho-behavioral Symptoms in Alzheimer's Disease and Related Disorders: Impact on Health Resources Use
- ClinicalTrials.gov ID
- NCT04820127
- Acronym / sponsor ID
- PERSON-AL / RC31/19/0555
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 29 Mar 2021 (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 present project propose to study the effectiveness of a personalized care management of psycho-behavioral symptoms based on an evidence-based standardized assessment to identify and understand the underlying causes of psycho-behavioral symptoms followed by a personalized intervention based on targeted and prioritized actions. This personalized intervention is proposed both to Alzheimer disease (AD) patients living at home with agitation-type psycho-behavioral symptoms, and also to their caregivers with the support and coordination of a nurse working in collaboration with the specialist physician and the General Practitioner (GP). News technologies are used to enhance the follow-up, based on telehealth, and caregiver training.
The project hypothesize that, for a vulnerable population at risk (AD patient with agitation and their caregivers) living at home, a personalized intervention, carried out and coordinated by a nurse in close collaboration with the specialist and GP, would reduce hospitalizations and have a positive effect on the disease evolution and caregiver distress. Also this personalized intervention could reduce the cost of care, in particular by reducing the costs associated with hospitalizations and informal help.
Detailed description
PERSON-AL is a multicentric, interventional, open-label, randomized, parallel-group, stratified by centre, study comparing two arms: usual care versus intervention (personalized care preceded by a standardized assessment)
Principal Objective : To evaluate the impact of a personalized intervention for the management of agitation due to psycho-behavioral symptoms on the use of scheduled and unscheduled hospitalizations at 18 months in patients with AD and related disorders.
Secondary Objectives:
A- To evaluate the impact of a personalized intervention at 18 months on:
For the patient:
- Unscheduled hospitalizations,
- Severity of agitation symptoms,
- The frequency and severity of emerging psycho-behavioral symptoms, other than agitation,
- Prescription of psychotropic drugs,
- Quality of life. For the caregiver:
- Distress related to psycho-behavioral symptoms,
- All causes hospitalizations,
- Quality of life.
B- Evaluate the medico-economic impact of this personalized intervention, and in particular:
- Its efficiency compared to usual management by means of cost-effectiveness and cost-utility analyses, from the community perspective and over a time horizon of 18 months,
- The actual cost of patient's standardized assessment and personalized management
- The use of care and associated costs for the caregiver and the efficiency of caregiver targeted intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (usual care) | No intervention | –Patients in the control group will benefit from the usual care with a half-yearly visit by the specialist physician (geriatrician, neurologist or psychiatrist) according to AD French national management guidelines (HAS 2011 and HAS 2018). |
| Intervention (personalized care program) | Experimental | Behavioral: personalized care preceded by a standardized assessmentPatients in the intervention group will benefit from personalized care preceded by a standardized assessment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosed with major neuro-cognitive disorders (DSM V) at all severity stages.
- Leaving at home
- Assisted by a caregiver, from patient's family or personal environment, assuming most of patient care (spending at least 6 hours per week with the patient)
- caregiver available to come with the patient to study visits as planned per protocol
- existing agitation since at least one month (according to International Psychogeriatric Association (IPA) criteria)
Key exclusion criteria (9 listed)
- Agitation symptoms attributable either to other concomitant prescriptions, or to other psychiatric or evolving somatic diseases.
- Patient living in a residential care facility or having an institutionalization project within 6 months
- Patient with clinically significant or unstable disease that could affect he/her ability to come for the study visit or complete the evaluations planned as per protocol
- Concomitant participation to any other interventional research study
- Patient under legal protection.
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 |
|---|---|---|
| personalized care preceded by a standardized assessment* personalized intervention plan (PIP) proposed to the patient/caregiver dyad to correct potentially reversible causes of psycho-behavioral symptoms. This PIP will be re-evaluated and adapted at each visit by the nurse in close collaboration with the GP; * PIP implementation will be based on a close follow-up during the 18 months follow-up coordinated by the nurse (3 memory consultation visits, 3 home visits (with the GP) and 6 phone calls). This follow up will be enhanced with the use of a web platform (allowing teleconsultation, tele-expertise and telemonitoring); * specific training on psycho-behavioral symptoms for caregivers at baseline and during follow-up will be performed. On line training on psycho-behavioral symptoms management for GP will be available; | Behavioural | Intervention (personalized care program) |
Primary outcome
patient's number of hospitalization at 18 months
Time frame: From the inclusion until End of Study, 18 months
number of all causes hospitalization, either scheduled or unscheduled, including emergency department visits
1 secondary outcome
patient's unscheduled hospitalization
Time frame: From the inclusion until End of Study, 18 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 8 May 2026.
- Individual participant dataSharing planned: No
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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.
Maria SOTO, MD principal investigator
University Hospital Toulouse - Gerontopole
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized care preceded by a standardized assessment in people with Alzheimer's Disease, run by University Hospital, Toulouse at 15 sites in France.
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 14 inclusion and 9 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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?
patient's number of hospitalization at 18 months (time frame: From the inclusion until End of Study, 18 months). 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 8 May 2026.