Contemporary Issues in Gerontology: Promoting Positive Ageing
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Active Aging: A Global Goal
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Dementia treatment is not an issue that MHA has addressed in the past, but the serious deficiencies of existing prescribing practices demands scrutiny. The next sections of this position statement will provide guidance for the present and advocacy for the future, with the caveat that psychosocial interventions should both precede and accompany drug therapy, and that while no cure is in sight, MHA holds out hope that some of the many current research initiatives will prove fruitful.
There is no magic pill to prevent the aging of the brain or the other causes of dementia. But the U. Food and Drug Administration FDA has approved three cholinesterase inhibitors -- donepezil Aricept , rivastigmine Exelon and galantamine Razadyne -- and one glutamate antagonist -- memantine Namenda — to treat the cognitive symptoms memory loss, confusion, and problems with thinking and reasoning of Alzheimer's disease.
Introduction to Aging and the Elderly
Some doctors also prescribe high doses of vitamin E for Alzheimer's disease, although that that is becoming less common. As stated by Consumer Reports: .
Among the few who do benefit, the improvement is typically slight. But they are not. They can cause side effects such as insomnia, nausea, muscle cramps, diarrhea, and reduced appetite, all of which can be troublesome for people with dementia. Rarely, the drugs may cause more serious side effects such as internal bleeding and a slowed heart rate that could be potentially dangerous. Cholinesterase inhibiters are widely endorsed and used. However, they are expensive, and the effect is modest at best. There is some evidence of permanent worsening of symptoms upon discontinuation of treatment,  so once started, it may be hard to stop until late in the course of the disease.
But there are inadequate data to substantiate this concern. The results of ten randomized, double blind, placebo controlled trials demonstrate that treatment for six months, with donepezil, galantamine or rivastigmine at the recommended dose for people with mild, moderate or severe dementia due to Alzheimer's disease produced improvements in cognitive function, on average Study clinicians rated global clinical state more positively in treated patients.
Benefits of treatment were also seen on measures of activities of daily living and behavior. None of these treatment effects are large. The effects are similar for patients with severe dementia, although there is very little evidence, from only two trials. As patients with DLB and PDD have particularly severe deficits in cortical levels of the neurotransmitter acetylcholine, blocking its breakdown using a group of chemicals known as cholinesterase inhibitors may lead to clinical improvement.
Six trials showed a statistically significant improvement in global assessment, cognitive function, behavioral disturbance and activities of daily living rating scales in PDD and cognitive impairment in Parkinson's disease CIND-PD patients treated with cholinesterase inhibitors. However, the effect is still modest. Finally, the conclusions of a Cochrane review of studies of the use of cholinesterase for mild cognitive impairment were quite negative:. There is very little evidence that cholinesterase inhibitors affect progression to dementia or cognitive test scores in mild cognitive impairment.
This weak evidence is overwhelmed by the increased risk of adverse events, particularly gastrointestinal. Cholinesterase inhibitors should not be recommended for mild cognitive impairment. Until a political decision was made to make cholinesterase inhibiters generally available in the U. National Health Service attempted to restrict reimbursement,  and experts like Peter Whitehouse  continue the dialogue in the United States. However, on balance, Whitehouse agrees that, in the current state of knowledge, he would be willing to prescribe cholinesterase inhibitors for dementia, because the effect, though small and by no means assured, could still be significant for the individual.
Moreover, in the last several decades increasing overlaps between aging and dementia and among types of dementias have become more apparent. Neuronal loss, plaques, and tangles all can occur in individuals who do not have a clinically apparent dementia. Our ability to differentiate these overlapping conditions from each other, much less from processes associated with aging, remain rudimentary. Even the allegedly clear-cut distinction between vascular disease and neurodegenerative disease is getting muddier the more we look at risk factors and biological markers.
This aptly describes a scientific tangle every bit as complicated as the tangles associated with dementia. More research is clearly necessary and may someday help American society to cope with what is likely to become an epidemic as our population ages.
The key is to pursue research into psychosocial as well as pharmacological interventions. But there are critical, practical issues that must be addressed right now in managing the psychiatric symptoms of cognitive impairment, and it is an indictment of our drug regulatory system that they are only now being addressed at all. People with dementia experience anguish and anxiety from life crises and loss of mental capacities and often have psychotic and depressive symptoms as well, and the agitation, depression and psychotic features impair quality of life, perhaps even more than the cognitive symptoms in many people.
For example, many people with dementia do not recognize where they are, even in their own home, or who is taking care of them, and feel unsafe, anxious and depressed. In the absence of data specific to older people or people with dementia, these symptoms have been treated with medications approved for anxiety principally benzodiazepines , depression, and psychosis. Antidepressants are effective in treating co-occurring depression and have not yet been controversial,  though testing in elderly populations has lagged.
The widespread off-label use of antipsychotics has raised the greatest problems. However, the use of benzodiazepines for anxiety is being called into question as well. They are effective but potentially addictive and definitely exacerbate delusions. Thus, their use should at least be minimized. In the absence of U. Food and Drug Administration FDA guidance, physicians have used off-label antipsychotics to treat psychotic symptoms of dementia.
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As of , one-quarter of nursing-home residents had used antipsychotics. Pharmacological therapies are not particularly effective for management of neuropsychiatric symptoms of dementia. Few studies of these drugs have been done in older people and in dementia of various types. Antipsychotics are widely used even though they increase the risk of death in elders.
As has been documented in a recent serialized book by Steven Brill, published by the Huffington Post,  drug companies have promoted off-label use of antipsychotics without seeking FDA approval for their claims. This situation requires a little explanation.
The FDA reviews drugs for efficacy and safety and approves drugs for specific conditions. These are the labeled indications. The FDA does not regulate or monitor physicians, who are governed only by state licensure and civil malpractice. Clinicians with appropriate state licensure may prescribe any drug approved by the FDA for any purpose for any other condition that they believe warrants using the drug, without regard to the FDA label. They have sometimes promoted off-label use, as illustrated by the following cautionary tale:.
The dilemma for a family or a person in treatment is that there is no pharmaceutical treatment approved by the FDA for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly people with dementia who do not have schizophrenia, even though the DSM 5 expressly states that antipsychotics are used for that purpose.
Thus, if available psychosocial care is inadequate to deal with the symptoms, when the family or the care facility has run out of options, a typical or atypical antipsychotic will be prescribed off-label. Based on an unscientific sample collected by MHA, hospice programs often prescribe haloperidol Haldol , an older and cheaper typical antipsychotic, while psychiatrists generally use atypical antipsychotics. But all use extremely low doses, and clinicians and care workers alike claim that the drugs are effective in a significant number of patients, based on their experience.
Yes, the evidence is weak, and there is a significant risk of stroke and other side effects, but if available psychosocial approaches fail, antipsychotic drugs will be used to deal with psychotic symptoms, especially when needed to preserve the safety of the staff and other people in treatment, and to avoid the use of seclusion and restraints.
Why then is someone not busy studying risperidone and other anti-psychotics and working on comparisons and improvements right now? The general answer is that private funding now dictates the direction of most research. This trend has emerged as the budget for the National Institutes of Health— the primary source of government funding for clinical trials — has been slashed 24 percent since amid belt-tightening in Washington.
The drug and medical device industry now funds six times more clinical trials than the federal government, according to the Johns Hopkins University researchers. That means companies with financial interests in the studies now have more control over what doctors and patients learn about new treatments.
And pharmaceutical companies are unlikely to address the use of antipsychotics in dementia care:. Second, because there are significant ethical issues whenever people have complicated medical conditions, as the elderly always do, and whenever competency is in question, as it is in anyone with dementia. MHA believes that a more significant additional sanction would be to require the manufacturer to conduct and disclose studies to back up its claim.
If additional authority is needed for the FDA to insist on full disclosure and additional studies of drugs being marketed and used off-label as frequently as are antipsychotics, MHA strongly supports congressional action to grant such authority. Academic researchers and public interest organizations like the Cochrane Collaboration should be recruited to help.
And NIH funding should be increased to focus more research on these drugs and others with major public health implications. Finally, MHA urges the pharmaceutical industry, in the public interest, to help build an evidence base of published and unpublished studies that it has conducted of the use of anti-psychotics to treat psychiatric conditions associated with dementia.
Whenever possible, the federal government should insist, in the interest of science, that ALL such studies be made available to the public. Psychotic symptoms of dementia are difficult for patients, clinicians, families and caregivers to deal with. Fortunately, the American Psychiatric Association has published a Practice Guideline issued in May, that can help guide clinicians, families and people in treatment until better evidence is available.