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

Avera McKennan Hospital & University Health Center

Status: Completed

Conditions: Alzheimer's Disease; Agitation

Study type: Observational

Funder types: Other

Identifiers

NCT01329536

AIHBG-1380-Agitation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

AD Patients with Agitation

Description:

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

Description:

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