Clinical trial NCT03554226: Agitation and Aggressivity in Alzheimer's Disease Patients: A Cohort Study
Official title: Agitation and Aggressivity in Alzheimer's Disease Patients: A Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: agitation
aggressivity
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Ethypharm
First posted: 2018-06-13
Enrollment: 270
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

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:

* 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Severity of A/A with NeuroPsychiatric Inventory Clinician (NPI-C)
timeFrame: Change between enrollment and 12 months
measure: The clinical relevance of the change observed by the clinician with Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
timeFrame: Change between enrollment and 12 months
Secondary outcomes:
measure: Cohen-Mansfield Agitation Inventory
timeFrame: Change between enrollment and 12 months
measure: Quality of Life QoL-AD
timeFrame: Change between enrollment and 12 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital (CHU de Toulouse)
Study officials:
affiliation: University Hospital, Toulouse
name: Maria SOTO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.