---
title: "The Occurrence of the ApoE4 Allele in Agitated In-Patients With Late-Onset Alzheimer's Disease"
nct_id: NCT01329536
overall_status: COMPLETED
sponsor: Avera McKennan Hospital & University Health Center
study_type: OBSERVATIONAL
primary_condition: "Alzheimer's Disease"
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01329536.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01329536"
ct_last_update_post_date: 2011-10-06
last_seen_at: "2026-05-12T07:21:13.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT01329536](https://clinicaltrials.gov/study/NCT01329536)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Avera McKennan Hospital & University Health Center
- **Conditions:** Alzheimer's Disease, Agitation
- **Start Date:** 2010-12
- **Completion Date:** 2011-10
- **CT.gov Last Update:** 2011-10-06

## 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

- **Minimum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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

## Primary Outcomes

- **Apolipoprotein E4 Allele** _(time frame: Single clinic visit (day 1))_ — 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.

## Locations (1)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.avera research institute|sioux falls|south dakota|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01329536.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01329536*  
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