Informations générales (source: ClinicalTrials.gov)
The Role of Personality in the Occurrence of Behavioural Disorders in Patients Suffering From Alzheimer Disease (PACO)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
janvier 2009
novembre 2015
29 juin 2024
Alzheimer's disease is characterised by a loss of cognitive functions and behavioural
problems as set out under the term "Behavioural and psychological symptoms of dementia
(BPSD)". The impact of BPSD in everyday life has heavy consequences for the patient and
their family. The precocity of incidence, the frequency and the intensity of the BPSD are
associated with a rapid decline in cognitive functions, an alteration in the activities
of daily living, and a decrease in the quality of life for both the patient and the
helper, an increased risk of hospitalisation and of institutionalisation as well as an
increase in the cost to the health system. A greater understanding of the risk factors
for the occurence of the BPSD would better allow the detection of patients who are
particularly at risk for BPSD, to anticipate the crisis situations by proposing early and
adapted care, and to better target the medicinal therapies. Certain observational
arguments or results of retrospective studies speak in favour of the role of the basic
personality in the occurence of BPSD in Alzheimer's disease. The investigators propose to
clarify this role through a prospective study.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service de Gériatrie - Hôpital des Charpennes - Hospices Civils de Lyon - 69100 - Villeurbanne - France | Pierre KROLAK-SALMON, Professor | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Male or female subject aged over 50 years ;
- In-patient or out-patient at one of the centres participating in the study ;
- Meeting all the diagnostic criteria for dementia due to AD (NINCDS ADRDA, CDR 1 or
2) or pre-dementia with a CDR of 0.5 (Berr et al., 2006, Dubois et al, 2007) ;
- Covered by the state's Social Security system ;
- With sufficient visual, auditory and oral and written French language skills to
complete the clinical and neuropsychological evaluations ;
- Accompanied by a caregiver in sufficient contact with the subject to be able to
assess their personality and note the onset of changes in behaviour.
- Male or female subject aged over 50 years ;
- In-patient or out-patient at one of the centres participating in the study ;
- Meeting all the diagnostic criteria for dementia due to AD (NINCDS ADRDA, CDR 1 or
2) or pre-dementia with a CDR of 0.5 (Berr et al., 2006, Dubois et al, 2007) ;
- Covered by the state's Social Security system ;
- With sufficient visual, auditory and oral and written French language skills to
complete the clinical and neuropsychological evaluations ;
- Accompanied by a caregiver in sufficient contact with the subject to be able to
assess their personality and note the onset of changes in behaviour.
- Patients with a progressive and/or poorly managed psychiatric pathology (patients
with stabilised depression could be included in the study) ;
- Patients taking any neuroleptic psychotropic medication ;
- Patients taking other psychotropic medication, with the exception of any
antidepressant, hypnotic, anxiolytic, acetylcholinesterase inhibitors or Memantine
which has been prescribed and stabilised for more than 3 months
- Patients with forms of dementia with an aetiology other than that of Alzheimer's
disease (frontotemporal dementia, vascular dementia, Lewy Body dementia, and types
of dementia that arise as a result of an underlying untreated disease, such as
dysthyroidism, vitamin B12 or folic acid deficiency, syphilis, anaemia or
hydroelectrolytic disorders) ;
- Patients with serious, progressive or unstable pathologies which could interfere
with the variables under consideration ;
- Deafness or blindness which could compromise evaluation of the patient ;
- Pregnancy ;
- Patients under any type of guardianship or belonging to a restricted category as
laid out in the Public Health Code ;
- Patients without a suitable caregiver willing to participate.