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The PACO Study ("Personnalité Alzheimer COmportement") (PACO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01297140
Recruitment Status : Unknown
Verified October 2014 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : February 16, 2011
Last Update Posted : October 3, 2014
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer Disease Behavioral: questioning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Role of Personality in the Occurrence of Behavioural Disorders in Patients Suffering From Alzheimer Disease
Study Start Date : January 2009
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Behavioural and psychological symptoms of dementia (BPSD) [ Time Frame: 18 months ]
    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 :
  1. social cognition tests [ Time Frame: during the inclusion visit ]
    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)

  2. connection between social cognitive tests and BPSD [ Time Frame: 18 months ]
    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.

  3. connection between cerebral atrophy and BPSD [ Time Frame: 18 months ]
    To evaluate the connection between the distribution of regional cerebral atrophy, determined by a MRI at the time of inclusion, and the risk of subsequent BPSD.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01297140

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Contact: Pierre KROLAK-SALMON, Professor

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Service de Gériatrie - Hôpital des Charpennes - Hospices Civils de Lyon Recruiting
Villeurbanne, France, 69100
Contact: Pierre KROLAK-SALMON, Professor   
Principal Investigator: Pierre KROLAK-SALMON, Professor         
Sponsors and Collaborators
Hospices Civils de Lyon
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon Identifier: NCT01297140    
Other Study ID Numbers: 2008.508
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: October 2014
Keywords provided by Hospices Civils de Lyon:
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders