The Hospice Clinician Blog

There are four different medications currently marketed for delaying the progression of dementia (see table below). None of these drugs will stop the progression of the disease and eventually they will no longer offer any benefits as the patient’s cognitive and functional decline reaches an advanced stage. Hospice clinicians are often faced with questions about the continued role of these drugs in their patients with advanced dementia. It is not just a question of whether or not the patient may continue to benefit from drug therapy, but issues of exposure to drug side effects and the high cost of these medications also factor into the discussions. To date, there have not been any published studies that address when to stop these medications in advanced dementia patients.

Galantamine and Rivastigmine are indicated for the management of mild to moderate dementia. Donepezil is indicated for mild, moderate, and severe dementia. Memantine is indicated for management of moderate to severe dementia. Clinical trials with these drugs were able to demonstrate some modest beneficial effect with decreased cognitive and functional decline. The clinical significance of these beneficial effects upon individual patients continues to be debated, even after a decade or more of widespread use. Expert opinion varies widely as to the actual benefits of these drugs, even in mild to moderate dementia and very few studies have examined the role of these drugs in severe dementia. Two major publications have cast significant doubt on the benefits of ChEI’s and memantine in the treatment of dementia in general. The first is a 2005 meta-analysis by Kaduszkiewicz, et al, published in the British Medical Journal which raised significant doubt on the degree of benefit of the cholinesterase inhibitor drugs in even mild to moderate dementia (1). These researchers analyzed 22 different, randomized, double blind, placebo controlled studies of donepezil, rivastigmine, and galantamine in the treatment of Alzheimer's dementia. They pointed out considerable flaws in the study methodologies and concluded that because of the study flaws and the small clinical benefits that were demonstrated, the scientific basis for using cholinesterase inhibitors for the treatment of Alzheimer’s dementia at any severity level is questionable.

The second publication to raise questions about the clinical significance of benefits reported with these drugs was the 2008 AAFP-ACP Guideline for medications in dementia. In March of 2008 the American Academy of Family Physicians (AAFP) and the American College of Physicians (ACP) published their joint guideline for the drug treatment of dementia in the Annals of Internal Medicine(2). This panel reviewed the medical literature and found only limited evidence regarding the effectiveness of the four drugs addressed in this article with regard to the following outcomes: cognition, global function, behavior/mood, and quality of life/activities of daily living. The AAFP-ACP guideline panel found that some clinical trials showed statistically significant improvements in dementia patients treated with one or another of these medications, however,"those improvements often weren't clinically significant." The panel concluded with the following statement:

"The magnitude of improvement in those trials often

was so small that patients or their caregivers may not be

interested in exposing the patient to the potential side effects

of the drug for such a modest benefit."

The issue in hospice generally revolves around the appropriateness of continuing these drugs in patients with late stage or end stage dementia. There are many subtypes of dementia which may have distinctive features (Pick’s disease, Lewy body disease, Parkinson’s dementia, and Alzheimer’s dementia, to name a few), however in late stage disease the symptoms of each subtype become very similar. Symptoms at late stage may include pronounced memory loss with the patient unable to recognize familiar objects or family, difficulty eating and swallowing, restlessness and confusion, considerable weight loss, incontinence, loss of speech, loss of ability to ambulate, and total dependence on nursing care. One of the ways that hospice care seeks to relieve suffering and improve end-of-life care is by reducing non-beneficial treatments for those diagnosed with end –stage dementia. It can be successfully argued the ChEI’s and Memantine have not been shown to offer any clinically significant benefits in end stage dementia.

Medicare guidelines offer extensive criteria for hospices to determine when a patient is eligible for the hospice benefit for management of end stage dementia. Hospices are supposed to follow Medicare guidelines for both accepting and retaining patients on service. The basis of the guideline is the Functional Assessment Staging scale, or FAST. This is a rating tool which is used to “stage” the patient from mild to severe dementia based upon the level of cognitive and functional decline observed. The FAST scale has 7 levels, with level one considered mild dementia and level 7 considered the most severe, or end stage.

 There are 6 sub-levels within level 7 (7a through 7f). The hospice eligibility criteria specifies that the patient must be at or beyond FAST level 7 and be unable to ambulate without assistance, and be unable to speak at least 6 intelligible words, along with several other impairments (see table below).

This requires that the patient be at least at level 7c severity on the FAST scale in order to receive hospice benefits under the diagnosis of dementia. While the ChEI’s and memantine may provide some benefits in cases of mild to moderate and possibly some cases of severe dementia, there are no published studies that demonstrates any benefits in end-stage dementia with patients at the 7c to 7f level on the FAST scale. A physician may determine that a dementia patient has a life expectancy of 6 months or less, even if the findings described earlier are not present. The presence of other co-morbidities may also support eligibility for hospice care. In many of these instances it may result in the patient being eligible for hospice under a general debility/decline diagnosis instead of end stage dementia.

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