Current alzheimer's medications: effective treatment options, or expensive bottles of hope?

some people with early- to moderate-stage AD score may not beaccurately measureThe ADAS-Cog, according to 2 studies re- ported in 2012, is a test instrument “not subtle enough to properly track changes in the early stages of Alzheimer’s.A major studyconducted by Consumer Reports in 201concluded that thedifferences in scores on the ADAS-Cog for patients taking any of theFDA-approved medications, when compared with placebo groups, are “smaller than 4 points, which is so small, it is not considered I am not a medical researcher, nor am I a medical doctor. I am, meaningful.” Consumer Reports also concluded that the “small however, a spouse caregiver for my wife, who is now in moderate improvements” showing slower rates of decline in activities of daily stages of Alzheimer disease (AD). My reading of the AD literature, living as measured by various instruments “would not be consid- my listening to other spouse caregivers, and my research on the ered clinically meaningful by most doctors.” effectiveness of current AD medications all tell me that doctors too The second research flaw is that clinical trials cited as evidence often recommend that patients with AD continue taking ineffective of the effectiveness of these medications are few, and of very brief “treatment medications.” Well after the time period when even the duration, with absolutely no data supporting any positive outcomes pharmaceutical manufacturers claim that their products are effec- beyond that clinical trial duration. I would think that if any phar- tive, many doctors continue to prescribe these same ineffective AD maceutical manufacturer had any evidence of its medication having any positive effects beyond the duration of their brief clinical trials,that evidence would be made public . in a heartbeat! All had clinical trials of short duration, all of the positive effects were leveling off or slowing down by the end of the trials, and all My wife took 2 of the most commonly prescribed AD medica- testing was with instruments that are not necessarily the best tions: donepezil (Aricept) and memantine (Namenda). Along with measurements of cognitive performance.
galantamine (Razadyne) and rivastigmine (Exelon), these are 4 of The Web site of Ortho-McNeil Neurologics, a division of Ortho- the 5 prescription medications that have been approved by the US McNeil-Janssen Pharmaceuticals, Inc., cites only 4 randomized, Food and Drug Administration (FDA) to treat people diagnosed with double-blind, placebo-controlled clinical investigations for galant- AD. A fifth medication, tacrine (Cognex), was also approved by the amine in patients with probable Using the ADAS-Cog to assess FDA, but is now rarely prescribed because of safety All cognitive performance, the 4 trials lasted 21, 26, 26, and 13 weeks, but memantine are termed “cholinesterase inhibitors” that respectively. At the end of these short-duration trials, results had “prevent the breakdown of acetylcholine, a brain chemical believed already either leveled off or begun to decline, even for the groups to be important for memory and thinking.”Memantine works demonstrating initial improvement. There is not even one study differently, by regulating glutamate, a brain chemical that, “when demonstrating that galantamine is effective to any degree whatsoever produced in excessive amounts, may lead to brain cell death.Each of these medications carries the possibility for side effects, such as On the Novartis Web site, one finds data from 5 clinical trials nausea, vomiting, or diarrhea, to name a few.
with patients with AD that lasted 12, 24, and 48 weeks usingrivastigmine in oral or “patch” form, and all relied on the ADAS-Cog and MMSE to measure outcomes. All trial results show that even forthe groups demonstrating improvement on the medication, Although there is absolutely no research to indicate that any of declines in scores appear after 24 weeks. There is not even one study these medications will stop or cure AD, there is some research to demonstrating that rivastigmine is effective to any degree whatsoever indicate that, for some patients, these medications may slow the rate of decline for a brief period of time. However, this research is On the Eisai/Pfizer Web site, one finds data from 4 clinical trials based on only a few clinical trials of very short duration, and this with patients with AD taking donepezil. Two trials were for research is badly flawed in 2 major respects.
patients with mild to moderate AD, 1 for 15 weeks and 1 for 30 The first research flaw is that the “significant positive outcomes” weeks. Two trials were for patients with moderate to severe AD, for obtained in clinical trials cited by drug manufacturers as “evidence” 24 weeks in Japan and 6 months in Sweden. Once again, even for of the effectiveness of their medications are usually based on groups demonstrating improvement on this medication, declines in results obtained on the Mini-Mental State Examination (MMSE) or scores begin at or before the 24-week stage as measured by the Alzheimer’s Disease Assessment ScaleeCognitive (ADAS-Cog) tests.
ADAS-Cog and other instruments. There is not even one study The MMSE, a commonly used AD screening test, is an instrument demonstrating that donepezil (Aricept) is effective to any degree that was never designed to diagnose AD, and cognitive declines in Letters to the Editor / JAMDA 14 (2013) 525e527 The Research Center of the Alzheimer’s Association provides much information about treatments for AD. Their conclusion with What do all clinical trials using cholinesterase inhibitors tell us? respect to current medication is this: “On average, the five Very simply, we learn that of the 11 clinical trials for these 3 approved Alzheimer’s drugs are effective for about sixe12 months medications, 9 of them lasted for 26 weeks or less. We also learn for about half of the individuals who take them.
that in every study, even patients showing initial evidence of The National Institutes of Health also recently affirmed that these improvement started to decline after 24 weeks, if not sooner.
AD medications are largely ineffective beyond a limited period of And, finally, we learn that there is absolutely no evidence indi- time. The executive summary of its comprehensive “Alzheimer’s cating that patients continuing to take these medications beyond Disease Progress Report,” 2011e2012, concludes that the current a very limited period of time, 1 year or less, will continue to demon- FDA-approved AD medications “may help some people” . but even strate any positive effects these medications may have had.
for those it does help, it is “only for months to a couple of years.” And what do we learn from clinical trials about the evidence of effectiveness of memantine? On the Forest Laboratories, Inc., Website, 2 studies are reported, 1 lasting 24 weeks and 1 for 28 weeks.
Outcomes were measured using 2 instruments, 1 to measure activities of daily living and 1 to measure cognitive function. In the28-week study, after 4 weeks, the group receiving a placebo started Doctors should definitely prescribe AD medications for several to decline; the group receiving memantine showed a slight months and even up to a year or 2 if they or their patients or improvement for 12 weeks, and then started to decline. In the 24- caregivers see positive effects. But doctors should not recommend week study, the treatment groups were different. One group that patients continue taking these medications once they are received memantine and donepezil, whereas the other group obviously ineffective. This practice must stop.
received memantine and a placebo. After 4 weeks, the group Doctors must accept that AD medications eventually become receiving memantine and the placebo started to decline, whereas expensive “bottles of hope” that will not slow down the inevitable the group receiving memantine and donepezil did not show degenerative progression of AD. Doctors must also accept that, by declines until the 8-week point. There is not even one study continuing to prescribe these medications year after year, long after demonstrating that memantine (Namenda), given with or without they can possibly still be helpful, they may unintentionally be doing donepezil, is effective to any degree whatsoever beyond 28 their patients and caregivers more harm than good.
Despite there being no research to support the effectiveness of these AD medications beyond a few months, at best, many doctorscontinue prescribing these medications for years and years. Notonly can these AD medications no longer be helping their patients, but they may actually be causing some harm. Maintaining patientson these medications long term may provide false hope to patients 1. National Institutes of Health, US Department of Health and Human Services.
Alzheimer’s disease medications fact sheet. July 2010; updated March 22, 2013.
and their caregivers. I refer to these medications as “bottles of hope” because as I watch my wife decline, I know that the medi- cations cannot possibly be helping anymore, if they ever did at all.
2. Vann A. Listen more carefully to Alzheimer’s caregivers. J Am Geriatr Soc 2012; For many patients and caregivers, the high costs of AD medi- 3. Cognitive test in Alzheimer’s drug trial may be flawed. Science Daily. Available cations present an economic hardship. Money spent on AD medi- cations is money that might otherwise be spent on day care 4. Evaluating prescription drugs used to treat: Alzheimer’s disease. Consumer programs, companions, home health aides, or other services that would actually improve the quality of their lives.
Another problem with continuing to take these medications for 5. Razadyne. Full US prescribing information. Titusville, NJ: Ortho-McNeil-Janssen Pharmaceuticals, Inc. pp. 2e4. Available at: many years may be long-term negative side effects. Negative side effects were reported to some degree in all of the short-duration 6. Exelon. Highlights of prescribing information. East Hanover, NJ: Novartis. pp.
clinical trials, but there are no data on long-term negative side 13e16. Available at: 2006. Accessed January 15, 2013.
effects. Side effects not initially apparent may surface after 7. Aricept. Highlights of prescribing information. Woodcliff Lake, NJ: Eisai, Inc.
continuing to take these medications year after year.
Doctors must be realistic and honest with both patient and caregiver. Absent research to the contrary, doctors should recom- 8. Namenda. Full prescribing information. St Louis, MO: Forest Pharmaceuticals.
mend that their patients discontinue taking these medications after 9. Evaluating prescription drugs used to treat: Alzheimer’s disease. Consumer The Best Buy Drugs Report, issued by Consumers Union in May 10. Alzheimer’s Association, Research Center, Science & Progress Treatment 2012, was not given much publicity until excerpts appeared in the Horizon section. Five FDA-approved Alzheimer’s drugs. Available at: Washington Post on January 7, 2013. Consumers Union, which reviewed more than 1100 research studies and articles on AD 11. National Institutes of Health, National Institute on Aging. A primer on Alzheimer’s medications, begins the recommendations section of their disease and the brain. NIH Alzheimer’s Disease Progress Report, 2011e2012, p. 9.
comprehensive 2012 report with this statement: “The medications used to treat mental decline in people with Alzheimer’s disease are not particularly effective. When compared to a placebo, mostpeople who take one will not experience a meaningful benefit. And it is the rare person who has a significant delay in the worsening of their symptoms over time.The recommendations pageconcludes with these words, “if the person taking the drugs does not show signs of improvement within three months, it is unlikelythey ever will, so the drug should then be stopped.”



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