Agitation and Aggressivity in Alzheimer's Disease Patients: A Cohort Study (A3C)

Toulouse University Hospital

Status: Completed

Conditions: Alzheimer Disease

Treatments: Behavioral: NeuroPsychiatric Inventory Clinician (NPI-C)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03554226

2014-A00673-44 (Other Identifier)

RC31/14/7163

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

270 participants in 1 patient group

AD Patients with NeuroPsychiatric Inventory Clinician (NPI-C)

Experimental group

Description:

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).

Treatment:

Behavioral: NeuroPsychiatric Inventory Clinician (NPI-C)