The PACO Study ("Personnalité Alzheimer COmportement")
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||The Role of Personality in the Occurrence of Behavioural Disorders in Patients Suffering From Alzheimer Disease|
- Behavioural and psychological symptoms of dementia (BPSD) [ Time Frame: 18 months ] [ Designated as safety issue: No ]To measure (at inclusion, and at 6, 12, 18 months) the effect of premorbid personality and life events on the likelihood of a patient with probable Alzheimer's disease being affected by each of the BPSD categories: hyperactivity, psychotic symptoms, mood symptoms and apathy.
- social cognition tests [ Time Frame: during the inclusion visit ] [ Designated as safety issue: No ]To evaluate, at the time of inclusion, the connection between the basic personality and the performance in social cognition tests (capacity to interact with others)
- connection between social cognitive tests and BPSD [ Time Frame: 18 months ] [ Designated as safety issue: No ]To evaluate (at inclusion and after 6, 12, 18 months) the connection between the performance of the social cognitive tests at the time of inclusion and the risks of occurrence of BPSD.
- connection between cerebral atrophy and BPSD [ Time Frame: 1 year ] [ Designated as safety issue: No ]To evaluate (at inclusion and after 1 year) the connection between the distribution of regional cerebral atrophy, determined by a MRI at the time of inclusion, the progression of regional atrophy after one year, and the risk of BPSD.
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Patients will be screened by questioning them and their caregiver and from the results of the clinical examination and the biological and neuroradiological tests habitually carried out in cases of dementia and following accepted procedures.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297140
|Contact: Pierre KROLAK-SALMON, Professorfirstname.lastname@example.org|
|Service de Gériatrie - Hôpital des Charpennes - Hospices Civils de Lyon||Recruiting|
|Villeurbanne, France, 69100|
|Contact: Pierre KROLAK-SALMON, Professor 04.72.43.31.13 email@example.com|
|Principal Investigator: Pierre KROLAK-SALMON, Professor|