US Pharm. 2008;33(6):49-50.

Alzheimer's disease is a brain disorder that affects a person's ability to carry out daily activities. This disorder is becoming an increasing problem in the United States as the population ages. Alzheimer's disease affects approximately 5.1 million Americans; 4.6 million of those affected are aged 75 years or older.1 Early diagnosis is believed to help patients maintain mental capacity; afford patients the opportunity to make their own decisions while capable; inform families of how to prepare for the future; and provide the best individualized treatment. Analyses have shown that up to 50% of patients who meet the criteria for dementia are not diagnosed in a primary care setting.1,2

Pathophysiology
The cause of Alzheimer's disease is not fully understood; however, several anatomical, chemical, and functional changes have been found to take place in patients with the disorder. The main changes occur in the cortex and the limbic structures of the brain, particularly the basal forebrain, amygdala, hippocampus, and cerebral cortex.2 Numbered among the brain alterations are cortical atrophy, degeneration of cholinergic neurons, presence of neurofibrillary tangles, and accumulation of neuritic plaques. 2 These alterations also may be present in other conditions or even in normal aging. The etiology of Alzheimer's disease is complex, and several mechanisms must be taken into consideration. New developments are emerging with respect to the roles of serotonin, glutamate, cholesterol, estrogen, and genetics in Alzheimer's disease.

Diagnosis
The existence of memory disorders is difficult to assess initially. Signs are usually more noticeable to the patient's family or close friends than to the patient. The American Academy of Neurology does not recommend the evaluation or testing of patients who are asymptomatic. Two organizations that have developed guidelines for the diagnosis of Alzheimer's disease are the National Institute of Neurological Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association.2 Guidelines also are included in the Diagnostic and Statistical Manual of Mental Disorders. Given the high number of underdiagnosed patients or patients diagnosed in the later stages of the disease, there is a clinical need for a device or method that may aid practitioners and patients with early diagnosis.

Early Alert Alzheimer's Home Screening Test
Developed by FMG Innovations, Early Alert is a noninvasive, self-administered olfactory test designed to help the patient detect one of the early warning signs of Alzheimer's disease. The manufacturer recommends that the screening test be conducted annually if the patient is older than 50 years of age. The price of the test ranges from $15 to $20, and it can be purchased only online or by telephone. The Early Alert test consists of 12 different cards, each containing a specific odor and a list of several choices from which the patient must select. The test should be performed only once, and it should not be conducted if the patient has congestion, sinusitis, or respiratory problems, as such conditions may alter the results. If a patient cannot distinguish four or more odors on the cards, the manufacturer recommends that the patient seek medical advice from a physician. A more detailed procedure is outlined in TABLE 1.




Efficacy
Several clinical studies have been conducted that describe the changes to the olfactory nerve and the nerve's relationship to Alzheimer's disease. No studies of the Early Alert Alzheimer's Home Screening Test have been conducted; however, analyses of a similar product were carried out at the University of Pennsylvania Medical Center. In one study, Pentzek et al concluded that a decrease in olfactory ability was more common in Alzheimer's disease than in depression and that deterioration of odor differentiation may be a useful tool for early diagnosis.3 In another analysis, Wilson et al demonstrated that patients with lower global cognition at baseline had a faster decline in olfactory capacity.4 More data are needed before it can be definitively determined whether the deterioration in a patient's olfactory ability is related to Alzheimer's disease.

Conclusion
The Early Alert Alzheimer's Home Screening Test may be a better option for physicians than for patients to use because the results can be misinterpreted by the layperson, thus creating unnecessary anxiety in patients.5 More studies are necessary before this product should be recommended to patients for home use. More information about the Early Alert Alzheimer's Home Screening Test can be found at the following Web site: www.testsymptomsathome.com/FMG01.asp.

REFERENCES
1. Alzheimer's Association. Alzheimer's Disease Facts and Figures 2007. www.alz.org/national/documents/report_alzfactsfigures2007.pdf. Accessed May 27, 2008.
2. DiPiro JT, Talbert RL, Yee GC, et al. Pharmacotherapy: A Pathophysiologic Approach. 6th ed. New York, NY: McGraw-Hill Medical; 2005:1154-1173.
3. Pentzek M, Grass-Kapanke B, Ihl R. Odor identification in Alzheimer's disease and depression. Aging Clin Exp Res. 2007;19:255-258.
4. Wilson RS, Schneider JA, Arnold SE, et al. Olfactory identification and incidence of mild cognitive impairment in older age. Arch Gen Psychiatry. 2007;64:802-808.
5. Test Medical Symptoms @Home, Inc. Early Alert Alzheimers Home Screening Test. www.testsymptomsathome.com/FMG01.asp. Accessed May 27, 2008.

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