Clinical trial NCT01329536: The Occurrence of the ApoE4 Allele in Agitated In-Patients With Late-Onset Alzheimer's Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Agitation
Keywords: Alzheimer's Disease
Agitation
Genetics
Apolipoprotein
ApoE4
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of probable Alzheimer's Disease (late-onset)

Brief summary: 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.

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 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

Primary outcomes:
measure: Apolipoprotein E4 Allele
timeFrame: Single clinic visit (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Michael Reiners, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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. doi: 10.1002/gps.1203.
citation: 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. doi: 10.1097/00002093-199700112-00007.
citation: 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. doi: 10.1016/j.jns.2004.11.022. Epub 2004 Dec 23.