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.|
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Behavioral: questioning||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||252 participants|
|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|
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.
- 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.
- 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)
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): 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|