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

October 6, 2021 updated by: University Hospital, Toulouse

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • Toulouse University Hospital (CHU de Toulouse)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AD Patients with 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).
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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
Change between enrollment and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohen-Mansfield Agitation Inventory
Time Frame: Change between enrollment and 12 months
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
Quality of Life QoL-AD
Time Frame: Change between enrollment and 12 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Ethypharm

Investigators

  • Principal Investigator: Maria Soto, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

November 5, 2017

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

June 13, 2018

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/14/7163
  • 2014-A00673-44 (Other Identifier: ANSM/ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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