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

Alzheimer Disease Clinical Trial

— A3C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554226
• Other study ID #: RC31/14/7163
• Secondary ID: 2014-A00673-44
• Status: Completed
• Phase: N/A
• Start date: November 1, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Psychomotor Agitation

Intervention

Behavioral:
• 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)

Locations

Country	Name	City	State
France	Toulouse University Hospital (CHU de Toulouse)	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Ethypharm

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change between enrollment and 12 months
Primary	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	Change between enrollment and 12 months
Secondary	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.	Change between enrollment and 12 months
Secondary	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	Change between enrollment and 12 months