The PACO Study ("Personnalité Alzheimer COmportement")

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01297140
First received: February 14, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Alzheimer Disease
Behavioral: questioning

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 252
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)
Arms Assigned Interventions
Experimental: questionary Behavioral: questioning
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297140

Contacts
Contact: Pierre KROLAK-SALMON, Professor 04.72.43.31.13 pierre.krolak-salmon@chu-lyon.fr

Locations
France
Service de Gériatrie - Hôpital des Charpennes - Hospices Civils de Lyon Recruiting
Villeurbanne, France, 69100
Contact: Pierre KROLAK-SALMON, Professor    04.72.43.31.13    pierre.krolak-salmon@chu-lyon.fr   
Principal Investigator: Pierre KROLAK-SALMON, Professor         
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01297140     History of Changes
Other Study ID Numbers: 2008.508
Study First Received: February 14, 2011
Last Updated: January 8, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Psychiatry
Behaviour
Alzheimer's
Personality

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014