The Occurrence of the ApoE4 Allele in Agitated In-Patients With Late-Onset Alzheimer's Disease - Full Text View

Purpose

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.

Condition
Alzheimer's Disease Agitation

Study Type:	Observational
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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by Avera McKennan Hospital & University Health Center:

Primary Outcome Measures:

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

Enrollment:	50
Study Start Date:	December 2010
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with a diagnosis of probable Alzheimer's Disease (late-onset)

Criteria

Inclusion Criteria:

Men and women who are at least 65 years of age
Meet the DSM-IV-TR criteria for late-onset Alzheimer's Disease (AD)

Exclusion Criteria:

Unable to provide informed consent or do not have a legally acceptable caregiver and/or representative present or available to enter into the informed consent process on the study subject's behalf
Diagnosis of a non-Alzheimer's type of dementia
Determined by the Principal Investigator (or his designee) that the study subject would be unsuitable for study participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329536

Locations

United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105

Sponsors and Collaborators

Avera McKennan Hospital & University Health Center

Investigators

Principal Investigator:

Michael Reiners, MD

Avera McKennan Hospital & University Health Center

More Information

Additional Information:

Avera Research Institute website This link exits the ClinicalTrials.gov site

Publications:

Bynum JP, Rabins PV, Weller W, Niefeld M, Anderson GF, Wu AW. The relationship between a dementia diagnosis, chronic illness, medicare expenditures, and hospital use. J Am Geriatr Soc. 2004 Feb;52(2):187-94.

Drachman DA. Aging of the brain, entropy, and Alzheimer disease. Neurology. 2006 Oct 24;67(8):1340-52. Review.

Mayeux R, Saunders AM, Shea S, Mirra S, Evans D, Roses AD, Hyman BT, Crain B, Tang MX, Phelps CH. Utility of the apolipoprotein E genotype in the diagnosis of Alzheimer's disease. Alzheimer's Disease Centers Consortium on Apolipoprotein E and Alzheimer's Disease. N Engl J Med. 1998 Feb 19;338(8):506-11. Erratum in: N Engl J Med 1998 Apr 30;338(18):1325.

Mirakhur A, Craig D, Hart DJ, McLlroy SP, Passmore AP. Behavioural and psychological syndromes in Alzheimer's disease. Int J Geriatr Psychiatry. 2004 Nov;19(11):1035-9.

Koss E, Weiner M, Ernesto C, Cohen-Mansfield J, Ferris SH, Grundman M, Schafer K, Sano M, Thal LJ, Thomas R, Whitehouse PJ. Assessing patterns of agitation in Alzheimer's disease patients with the Cohen-Mansfield Agitation Inventory. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S45-50.

Fitzpatrick AL, Kuller LH, Lopez OL, Kawas CH, Jagust W. Survival following dementia onset: Alzheimer's disease and vascular dementia. J Neurol Sci. 2005 Mar 15;229-230:43-9. Epub 2004 Dec 23.

Responsible Party:	Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:	NCT01329536 History of Changes
Other Study ID Numbers:	AIHBG-1380-Agitation
Study First Received:	January 11, 2011
Last Updated:	October 4, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:

Alzheimer's Disease
Agitation
Genetics
Apolipoprotein
ApoE4

Additional relevant MeSH terms:

Alzheimer Disease
Psychomotor Agitation
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013