Alzheimer DiseaseA3CNCT03554226
Agitation and Aggressivity in Alzheimer's Disease Patients: A Cohort Study
A study testing NeuroPsychiatric Inventory Clinician (NPI-C) in people with Alzheimer Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
General Hypothesis: hypothesize that A / A symptoms of AD follow a particular course, influenced by associated factors, and a prospective longitudinal observational study specifically evaluating A / A symptoms in patients with MA, living in an institution and at home, would provide useful data for both clinical… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- NeuroPsychiatric Inventory Clinician (NPI-C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2014to 31 Dec 2018
- 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
- 1256/5000
- Patient with AD according to NINCDS-ADRDA criteria with or without cerebrovascular component at all stages of the disease.
- Patient with agitation / aggression (A / A) type SPCDs, assessed with a score ≥ 4 of at least 1 of the A / A domains, disinhibition, irritability and / or aberrant motor behavior of the NPI scale, with a score frequency ≥2 during the inclusion visit.
- Participation agreement signed by the patient or, in the event of the patient's incapacity, by his / her legal representative or, as the case may be, by the person of trust or family. The patient's ability to sign informed consent is evaluated by a clinician experienced in the field of dementia.
- Patient with social security
- If the patient lives at home:
Show all 10Show fewer
- Presence of a clearly identified primary caregiver: Person from the entourage of the patient who assumes the main part of the care (at least 2 hours at least 3 times during the week) able to complete the questionnaires and to evaluate the patient.
- Availability and agreement of the carer to accompany the patient during consultations.
- If the patient lives in an institution:
- He / she must have been there for at least 2 months before inclusion.
Who cannot join
- 745/5000
- Brain pathology (other than AD) that may be the cause of dementia: extensive cerebrovascular disease, Parkinson's disease, Lewy body dementia, frontotemporal dementia, brain trauma.
- A / A secondary to concomitant medications, or to a medical or psychiatric condition
- Concurrent major depressive episode (DSM-IV).
- Psychotic symptoms of delirium type and hallucination clinically significant (score ≥ 4 field delusions and / or hallucinations of the NPI scale).
- Presence of concomitant pathologies preventing participation in the study (testing and / or study visits).
- Concurrent participation in another research that may influence the testing of our study.
Trial locations and contacts
1 site in 1 country.
About this study
General Hypothesis: hypothesize that A / A symptoms of AD follow a particular course, influenced by associated factors, and a prospective longitudinal observational study specifically evaluating A / A symptoms in patients with MA, living in an institution and at home, would provide useful data for both clinical practice and research.
Specific Hypothesis: hypothesize that in patients with AD with clinically significant A / A there is a correlation between assessment of A / A severity based on specific scales of A / A and overall impression assessment of clinical improvement or worsening of these symptoms by the clinician.
- Conditions
- Alzheimer Disease
- Being tested
- NeuroPsychiatric Inventory Clinician (NPI-C)
- Keywords
- agitation, aggressivity
- Medical subject headings
- Alzheimer Disease, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroPsychiatric Inventory Clinician (NPI-C)Behavioural
All scales that will be administered to the patient during this study, (ADL, MMSE, QoL-AD, NPI and CMAI), are the subject of recommendations for the management of patients with AD (HAS 2009, HAS 2011)
| Study group | Role | What they receive |
|---|---|---|
| AD Patients with NeuroPsychiatric Inventory Clinician (NPI-C) | Experimental | The investigation aims to study the natural evolution of type A / A SPCDs in patients with AD. In this study, patients will receive optimized management based on existing best practice recommendations (HAS Recommendations 2009). It will therefore be a standard care study, since this survey applies the current recommendations on tools for the evaluation of SPCDs and the management of behavioral disorders in Alzheimer's disease (Recommendations HAS 2009). Receives: Behavioral: NeuroPsychiatric Inventory Clinician (NPI-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of A/A with NeuroPsychiatric Inventory Clinician (NPI-C)
The severity of the A / A will be evaluated using the scale:
NeuroPsychiatric Inventory Clinician (NPI-C): combined score of 2 domains agitation and aggression (from Medeiros, 2010).
The purpose of the NPI-C is to collect information on the presence of neuropsychiatric symptoms in patients with cerebral pathologies.
The rating of all the behavioral domains of the NPI-C scale (C for Clinician) also makes it possible to measure the scores of the other symptoms.
Measured: Change between enrollment and 12 months
The clinical relevance of the change observed by the clinician with Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
The clinical relevance of the change observed by the clinician will be based on the A / A-specific section of the modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) (Drye et al, 2012).
The ADCS-CGIC was developed to evaluate the clinical significance of the evolutions observed in therapeutic trials on Alzheimer's disease, and is based on the measured changes compared to the initial evaluation. The modified version, mADCS-CGIC, evaluates the clinical relevance of a treatment based on the measurement of changes assessed by a clinician. The assessment is performed by a trained clinician at the scale
Measured: Change between enrollment and 12 months
Secondary outcomes (2)
Cohen-Mansfield Agitation Inventory
The original version contains 29 items and contains verbal aggression, physical items and items not related to aggression. The rating of items is done on the occurrence of the frequency of disorders in the previous two weeks on a scale of 0 to 7.
Measured: Change between enrollment and 12 months
Quality of Life QoL-AD
Quality of life for patients and caregivers will be based on the QoL-AD scale at V0, V3, V6 and V12.
Quantitative variable, therefore this evaluation criterion will be expressed as an average. The passing of the scale lasts approximately 5 minutes. This scale will be evaluated by a TEC : The QOL-AD is administered in interview format to individuals with question the quality of life for Alzheimer's patients
Measured: Change between enrollment and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start1 Nov 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Ethypharm
- Responsible party
- Sponsor
- Investigators
- Maria SOTO, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554226
- Sponsor's protocol ID
- RC31/14/7163
- Other IDs
- 2014-A00673-44
- Acronym
- A3C
- Status last verified
- Oct 2021
- First submitted
- 5 Nov 2017
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Mauleon A, Delrieu J, Cantet C, Vellas B, Andrieu S, Rosenberg PB, Lyketsos CG, Soto Martin M. Longitudinal Course of Agitation and Aggression in Patients with Alzheimer's Disease in a Cohort Study: Methods, Baseline and Longitudinal Results of the A3C Study. J Prev Alzheimers Dis. 2021;8(2):199-209. doi: 10.14283/jpad.2020.66.
PubMed 33569568Costa N, Marcelo Fleuret C, Gombault E, Soto Martin M, De Mauleon A. Longitudinal Impact of Agitation and Aggression Symptoms on Societal Costs in Alzheimer's Disease: A Focus on Informal Care and Socioeconomic Disparities. Int J Geriatr Psychiatry. 2026 Oct;41(10):e70257. doi: 10.1002/gps.70257.
PubMed 42821808
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agitation and Aggressivity in Alzheimer's Disease Patients: A Cohort Study
- ClinicalTrials.gov ID
- NCT03554226
- Acronym / sponsor ID
- A3C / RC31/14/7163
- Conditions
- Alzheimer Disease
- Keywords
- agitation, aggressivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Ethypharm
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Jun 2018 (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.
General Hypothesis: hypothesize that A / A symptoms of AD follow a particular course, influenced by associated factors, and a prospective longitudinal observational study specifically evaluating A / A symptoms in patients with MA, living in an institution and at home, would provide useful data for both clinical practice and research.
Specific Hypothesis: hypothesize that in patients with AD with clinically significant A / A there is a correlation between assessment of A / A severity based on specific scales of A / A and overall impression assessment of clinical improvement or worsening of these symptoms by the clinician.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD Patients with NeuroPsychiatric Inventory Clinician (NPI-C) | Experimental | Behavioral: NeuroPsychiatric Inventory Clinician (NPI-C)The investigation aims to study the natural evolution of type A / A SPCDs in patients with AD. In this study, patients will receive optimized management based on existing best practice recommendations (HAS Recommendations 2009). It will therefore be a standard care study, since this survey applies the current recommendations on tools for the evaluation of SPCDs and the management of behavioral disorders in Alzheimer's disease (Recommendations HAS 2009). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1256/5000
- Patient with AD according to NINCDS-ADRDA criteria with or without cerebrovascular component at all stages of the disease.
- Patient with agitation / aggression (A / A) type SPCDs, assessed with a score ≥ 4 of at least 1 of the A / A domains, disinhibition, irritability and / or aberrant motor behavior of the NPI scale, with a score frequency ≥2 during the inclusion visit.
- Participation agreement signed by the patient or, in the event of the patient's incapacity, by his / her legal representative or, as the case may be, by the person of trust or family. The patient's ability to sign informed consent is evaluated by a clinician experienced in the field of dementia.
- Patient with social security
Key exclusion criteria (7 listed)
- 745/5000
- Brain pathology (other than AD) that may be the cause of dementia: extensive cerebrovascular disease, Parkinson's disease, Lewy body dementia, frontotemporal dementia, brain trauma.
- A / A secondary to concomitant medications, or to a medical or psychiatric condition
- Concurrent major depressive episode (DSM-IV).
- Psychotic symptoms of delirium type and hallucination clinically significant (score ≥ 4 field delusions and / or hallucinations of the NPI scale).
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 |
|---|---|---|
| NeuroPsychiatric Inventory Clinician (NPI-C)All scales that will be administered to the patient during this study, (ADL, MMSE, QoL-AD, NPI and CMAI), are the subject of recommendations for the management of patients with AD (HAS 2009, HAS 2011) | Behavioural | AD Patients with NeuroPsychiatric Inventory Clinician (NPI-C) |
Primary outcome
Severity of A/A with NeuroPsychiatric Inventory Clinician (NPI-C)
Time frame: Change between enrollment and 12 months
The severity of the A / A will be evaluated using the scale: NeuroPsychiatric Inventory Clinician (NPI-C): combined score of 2 domains agitation and aggression (from Medeiros, 2010). The purpose of the NPI-C is to collect information on the presence of neuropsychiatric symptoms in patients with cerebral pathologies. The rating of all the behavioral domains of the NPI-C scale (C for Clinician) also makes it possible to measure the scores of the other symptoms.
The clinical relevance of the change observed by the clinician with Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
Time frame: Change between enrollment and 12 months
The clinical relevance of the change observed by the clinician will be based on the A / A-specific section of the modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) (Drye et al, 2012). The ADCS-CGIC was developed to evaluate the clinical significance of the evolutions observed in therapeutic trials on Alzheimer's disease, and is based on the measured changes compared to the initial evaluation. The modified version, mADCS-CGIC, evaluates the clinical relevance of a treatment based on the measurement of changes assessed by a clinician. The assessment is performed by a trained clinician at the scale
2 secondary outcomes
Cohen-Mansfield Agitation Inventory
Time frame: Change between enrollment and 12 months
Quality of Life QoL-AD
Time frame: Change between enrollment and 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 14 Oct 2021.
- Results publication: PubMed 33569568De Mauleon A, Delrieu J, Cantet C, Vellas B, Andrieu S, Rosenberg PB, Lyketsos CG, Soto Martin M. Longitudinal Course of Agitation and Aggression in Patients with Alzheimer's Disease in a Cohort Study: Methods, Baseline and Longitudinal Results of the A3C Study. J Prev Alzheimers Dis. 2021;8(2):199-209. doi: 10.14283/jpad.2020.66.
- Derived from this study: PubMed 42821808Costa N, Marcelo Fleuret C, Gombault E, Soto Martin M, De Mauleon A. Longitudinal Impact of Agitation and Aggression Symptoms on Societal Costs in Alzheimer's Disease: A Focus on Informal Care and Socioeconomic Disparities. Int J Geriatr Psychiatry. 2026 Oct;41(10):e70257. doi: 10.1002/gps.70257.
- 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.
Maria SOTO, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroPsychiatric Inventory Clinician (NPI-C) in people with Alzheimer Disease, run by University Hospital, Toulouse at 1 site 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 10 inclusion and 7 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 14 Oct 2021. 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 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?
Severity of A/A with NeuroPsychiatric Inventory Clinician (NPI-C) (time frame: Change between enrollment and 12 months). The study lists 2 primary outcomes in all. 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 NCT03554226, which also lists 2 linked publications.
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 14 Oct 2021.