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

NCT ID: NCT01329536

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Alzheimer's Disease Agitation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avera McKennan Hospital & University Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Reiners, MD

Role: PRINCIPAL_INVESTIGATOR

Avera McKennan Hospital & University Health Center

Locations

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Avera Research Institute

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

References

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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. doi: 10.1111/j.1532-5415.2004.52054.x.

Reference Type BACKGROUND
PMID: 14728626 (View on PubMed)

Drachman DA. Aging of the brain, entropy, and Alzheimer disease. Neurology. 2006 Oct 24;67(8):1340-52. doi: 10.1212/01.wnl.0000240127.89601.83.

Reference Type BACKGROUND
PMID: 17060558 (View on PubMed)

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. doi: 10.1056/NEJM199802193380804. Erratum In: N Engl J Med 1998 Apr 30;338(18):1325.

Reference Type BACKGROUND
PMID: 9468467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15481075 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9236952 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15760618 (View on PubMed)

Other Identifiers

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AIHBG-1380-Agitation

Identifier Type: -

Identifier Source: org_study_id