The Occurrence of the ApoE4 Allele in Agitated In-Patients With Late-Onset Alzheimer's Disease
The purpose of this clinical research study is to determine if a specific genetic allele is involved with the development of agitation in patients with late-onset Alzheimer's Disease (AD). The study will compare the results of genetic testing between two groups: individuals with late-onset AD who show signs of agitation and individuals with late-onset AD who do not show signs of agitation.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||The Occurrence of the ApoE4 Allele in Agitated In-Patients With Late-Onset Alzheimer's Disease Compared to Age- and Gender-Matched, Non-Agitated In-Patients With Late-Onset Alzheimer's Disease|
- Apolipoprotein E4 Allele [ Time Frame: Single clinic visit (day 1) ] [ Designated as safety issue: No ]This study consists of a single clinic visit. After subject has completed the informed consent process and meets eligibility criteria, a blood sample and a saliva sample will be collected. Genetic results from this one-time specimen collection will be evaluated and compared with results from participants in the other study group of age- and gender-matched patients. Outcomes will be measured comparatively.
Biospecimen Retention: Samples With DNA
saliva and blood
|Study Start Date:||December 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
AD Patients with Agitation
Patients with a diagnosis of probable Alzheimer's Disease who show signs of agitation based on the Cohen-Mansfield Agitation Inventory
AD Patients without Agitation
Patients with a diagnosis of probable Alzheimer's Disease who do not show signs of agitation based on the Cohen-Mansfield Agitation Inventory and are matched in both age and gender to the AD Patients with Agitation
Agitation and other behavioral disturbances are a main cause in the need for increasing levels of care for the patient with Alzheimer's disease (AD). And while the pathology of dementia has been studied in great detail, the etiology is considered multi-factorial. The hypothesis behind this clinical study is that the presence of the apo lipoprotein E4 (APO E4) allele will serve to predict which patients with late on-set AD are at greater risk to develop agitation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329536
|United States, South Dakota|
|Avera Research Institute|
|Sioux Falls, South Dakota, United States, 57105|
|Principal Investigator:||Michael Reiners, MD||Avera McKennan Hospital & University Health Center|