Agitation and Aggressivity in Alzheimer's Disease Patients: A Cohort Study
NCT ID: NCT03554226
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
270 participants
INTERVENTIONAL
2014-11-01
2018-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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).
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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Ethypharm
INDUSTRY
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Maria SOTO, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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Toulouse University Hospital (CHU de Toulouse)
Toulouse, , France
Countries
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References
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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.
Other Identifiers
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2014-A00673-44
Identifier Type: OTHER
Identifier Source: secondary_id
RC31/14/7163
Identifier Type: -
Identifier Source: org_study_id