Test developers, health care facilities, and other sources are marketing a growing number of screening tests directly to consumers. Some of these tests are offered on a "self-referred" basis (individuals taking the test do not need a physician's order for it), and the testing facility reports the results directly to the examinee. Self-referred testing is a controversial practice. It is lucrative for facilities administering these tests because consumers must pay for them directly. Insurance plans generally do not pay for self-referred procedures, so facilities offering them can set their own price and require payment in advance.

The Alzheimer's Association has received numerous questions about two dementia-screening tests recently marketed directly to consumers. One is the Early Alert Alzheimer's Home Screening Test, available in pharmacies and from a Web site. The other is the Minnesota Cognitive Acuity Screen (MCAS), sold by telephone and through a Web site. The Alzheimer's Association believes that no single dementia screening procedure is a meaningful substitute for established diagnostic criteria for Alzheimer's disease administered by a skilled physician. Although these screening tests do not claim to offer a definitive diagnosis, any test that may plant the idea of a serious illness in a test-taker's mind has the potential to cause great psychological distress. The whole process of assessment, diagnosis, and diagnostic disclosure should be carried out within the context of an ongoing relationship with responsible health care professionals.

back to top

This test, marketed by FMG Innovations, Inc., sells for around $15 - $20 in pharmacies and on the Internet. It is packaged in a small box that contains an instruction sheet, a pencil, and a booklet with 12 "scratch and sniff" odor strips. Examinees are instructed to scratch each strip to release the smell, and then circle one of four words that best describe the odor. Choices include "cinnamon," "dog," "soap," "garlic," "motor oil," fruit and floral fragrances, and a variety of other scents.

Correct answers are provided in an answer key at the back of the booklet. Examinees with four or more incorrect choices are advised to consult their physician. The instruction sheet states, "Smell loss is among the first signs of Alzheimer's disease. Experts recommend screening for smell loss once a year after the age of 65." It is true that there are legitimate scientific investigations exploring a possible link between smell loss and Alzheimer's disease, but the relationship has not been confirmed or quantified. No currently accepted diagnostic criteria for Alzheimer's include evaluation of smell, and there is no recommendation for annual smell testing from any recognized authority involved in establishing clinical guidelines.

Many factors other than Alzheimer's disease can impair smell, including current smoking or past smoking, certain drugs, a wide variety of medical conditions, and individual differences in sensitivity to odors. Medical and diagnostic equipment, including products marketed directly to consumers, is regulated by the Center for Devices and Radiologic Health (CDRH) of the U.S. Food and Drug Administration (FDA). According to a CDRH spokesperson, the Early Alert smell test has not been cleared or approved for marketing.

back to top

The MCAS is sold by telephone and over the Internet for $95 by Nation's CareLink, a care management firm specializing in geriatric assessments. The test consists of a 15-minute question-and-answer telephone interview administered by a registered nurse who asks test-takers such questions as their name, address, and birthday, what day it is, and how they would handle an emergency such as a fire in their home. Examinees are also asked to repeat a six-digit number, to remember 10 words, and to tap on the telephone when instructed. Nurses score each examinee, and those whose scores fall below certain levels are considered to need monitoring or to have "failed" the test.

The test's developers recommend annual testing. This recommendation does not reflect a policy established by any recognized clinical guideline. The chief use of the MCAS has been for commercial rather than clinical purposes. The test was developed by Nation's CareLink as a risk management tool to help insurers avoid issuing long-term care policies to individuals judged likely to develop dementia.

The MCAS Web site describes the test as "98.1 percent effective in identifying cognitive function." In support of this statement, MCAS cites an article published by the test's developers in the October 2000 edition of the journal Neuropsychiatry, Neuropsychology, and Behavioral Neurology. The abstract of this article on PubMed, the on-line literature database for the U.S. National Library of Medicine, concludes with the developer's own statement that "The Minnesota Cognitive Acuity Screen (MCAS) should undergo further study in unselected elderly populations to better understand its value as a screening tool. " The PubMed database contains no additional articles about the test.

back to top