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Completed

NCT Number: NCT03554226

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

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Ethypharm

Registry information

Acronym: A3C

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 13, 2018
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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