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

NCT03554226 | Completed

• 2 other identifiers: RC31/14/71632014-A00673-44
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

agitation; aggressivity

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Cohen-Mansfield Agitation Inventory

  Change between enrollment and 12 months

• Quality of Life QoL-AD

  Change between enrollment and 12 months

Study Arms (1)

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).

Behavioral: NeuroPsychiatric Inventory Clinician (NPI-C)

Interventions

NeuroPsychiatric Inventory Clinician (NPI-C) BEHAVIORAL

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)

AD Patients with NeuroPsychiatric Inventory Clinician (NPI-C)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• /5000
• Patient with AD according to NINCDS-ADRDA criteria with or without cerebrovascular component at all stages of the disease.
• 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:

You may not qualify if:

• /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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Ethypharm: collaborator

Study Sites (1)

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

Location

Related 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 Study. J Prev Alzheimers Dis. 2021;8(2):199-209. doi: 10.14283/jpad.2020.66.

  PMID: 33569568 RESULT

MeSH Terms

Conditions

Alzheimer Disease; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Maria SOTO, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: June 13, 2018
• Study Start: November 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

FR (1)