Alzheimer's Disease Plus Psychosis-Part XXV of a XXVIII Article

(1/27/09)- Eli Lilly & Co. agreed to pay $1.4 billion to settle criminal and civil charges that it illegally marketed it antipsychotic drug Zyprexia for unauthorized use in patients, particularly the elderly suffering from dementia and young children.

In one marketing campaign, the company urged geriatricians to use the drug to sedate unruly nursing home patients so as to reduce "nursing time and effort", according to court documents. These marketing campaigns were done in the face of strong evidence as to how dangerous the drug was to the young and the elderly.

There was strong evidence that the drug caused severe weight gain and metabolic disorders in young children. The U.S. attorney's office of the Eastern District of Pennsylvania was prosecuting the case. The amount of the settlement is a record sum for so-called whistle blower cases. In this case the whistle-blowers have not been named.

If Lilly had been convicted in the case the company could have been barred from participating in the federal Medicare and Medicaid programs. Zyprexia is Lilly's biggest selling drug, with over $4.8 billion in sales in 2007. The drug has been approved only for the treatment of schizophrenia and the mania and agitation associated with bipolar disorder.

It is unclear at this time whether or not the states, which are parties to the case, have agreed to the terms.

(6/25/08)- The FDA warned doctors that prescribing a group of anti-psychotic drugs to older people suffering from dementia could increase their risk of death.The announcement was an update to a 2005 action, when regulators added warnings about increase risk of heart attacks and pneumonia to drug called atypical anti-psychotics. The medicines include Zyprexia, made by Eli Lilly & Co, and Johnson & Johnson's Risperdal.

The agency said those same risks applied to 11 older drugs known as typical anti-psychotics, including Navane, made by Pfizer and Moban, made by Endo Pharmaceuticals.

Under the agency's order, both drug types will now carry boxed warnings, the most serious warning labels a drug can carry.

(7/14/04)- Today, Alzheimer's disease (AD) is a progressive neurodegenerative brain disorder with prominent symptoms affecting cognition, mood, thinking, behavior and movement. Subsumed within the diagnosis of Alzheimer's disease is a subset of AD that attempts to account for different expressions of the disease. One such subset is Alzheimer's disease with Psychosis (AD+P). In some studies, the incidence of this subtype reaches up to 60%, thus making it the most prominent subtype of AD. It may become most prominent in the later stages of Alzheimer's disease.

The dominant symptom present in AD+P is the presence of delusions and/or hallucinations. The cognitive impairment tends to be more severe as well as more rapid general decline, especially in daily function. These symptoms also lead to a quicker institutionalization. The individual may become aggressive, difficult to manage, rejecting of any help and a danger to him or herself.

The delusions expressed in AD+P run a wide gamut, but can be divided into two categories: paranoid, involving persecutory delusions and misidentification involving the presence of misidentification.

A delusion is a false belief, not attributable to membership in a social or cultural group. The belief arises from an incorrect inference about external reality. Delusions are different from confabulations due to cognitive impairments by their persistence and their resistance to persuasion or contrary evidence. The delusions commonly seen in AD+P include delusions of persecution, delusions of infidelity and delusions of abandonment. All of these types of delusions fall under the paranoid category because they involve ideas of reference.

Misidentification delusions include belief that one's home is not one's home, belief that a family member is someone else, belief in phantom boarders, belief that images on the TV are actual people present in the house, or that certain people are imposters. Another, not so uncommon belief, is misidentifying people or things as well as not identifying oneself in the mirror. The common denominator involves a misidentification of reality.

Hallucinations involve sensory perceptions for which there was no basis in reality.

Rachelle Doody, MD, Ph.D found that "Some patients with AD have hallucinations, delusions (fixed false beliefs) and other psychotic disturbances, while others do not. We have found that patients with these "positive" neuropsychiatric features often have "negative" features as well, such as apathy, reduced speech, social withdrawal, and reduced physical activity, and that studies of language in these patients implicate the left temporal lobe in all neuropsychiatric symptoms. Patients with psychotic features do not seem to have a personal or family history of psychosis, but do have more behavioral problems than patients without psychosis. There appears to be a particular SPECT pattern associated with delusions (left greater than right frontal lobe defect) and possibly with hallucinations (bilateral parietal lobe defects)". (Information found at the ADRC web site on November 12, 2004- )

Dr. Doody mentions one form of neuroimaging, SPECT (Single Photon Emission Computed Tomography), as a way of looking into the brain to see what is going on over time. The objective is to see changes in the brain that may be indicative of AD. The following point re neuroimaging is made by Jeffrey L. Cummings (New Engl. J. Med. 2004 351:56): "Neuroimaging plays an important role in the diagnosis of Alzheimer's disease and is particularly helpful in excluding alternative causes of dementia. It is currently recommended that patients undergo structural imaging of the brain with computed tomography (CT) or magnetic resonance imaging at least once in the course of their dementia. Functional imaging with positron-emission tomography or single-photon-emission CT may be helpful in the differential diagnosis of disorders associated with dementia."

The greater precision in diagnosis associated with neuroimaging will bring the more precise targeting of drug therapy to help deal with the range of psychotic symptoms associated with Alzheimer's disease. It may give insight as to what sites are to be targeted to impede or stop the progress of the disease. Neuroimaging may provide a picture of the process to enable the development of vaccines to prevent AD. Such breakthroughs are necessary to stop a crippling neurodegenerative disease that is projected to effect 20 million people in the not so distant future.

For some other articles on Alzheimer's Disease Please See:

See: Alzheimer's Disease Part I-Medications for Alzheimer's.
See: Alzheimerís Disease Part II- Selegiline and AD.
See: Alzheimer's Disease Part III- Use of Gingko Biloba in memory problems of Alzheimer patients
See: Part IV-Alternative Treatments for AD
See: Part V-Possible New Drugs for Alzheimer's Disease
See: Part VI-Early Diagnosis
See: Part VII-Metrifonate
See:Alzheimer's Disease PartVIII - Implications of Longer Life Expectancies
See: Alzheimer's Part IX-Ethical Care Principles
See: Alzheimer's Disease-Part X-Estrogen and Alzheimer's Disease
See: Alzheimer's Disease Part XI-Pocket Smell Test (PST)
See: Alzheimer's Disease Part XII-MAO-B
See: Alzheimer's Disease Part XIII -Critical Flicker Fusion Threshold Test
See: Alzheimer's Disease Part XIV-Donepezil
See: Alzheimer's Disease Part XV-Cerebrolysin
See: Alzheimer's Disease Part XVI-MCI
See: Alzheimer's Disease Part XVII-Summary
See: Alzheimer's Disease Part XVIII-NO Releasing NSAIDs
See: Alzheimer's Disease Part XIX-Vitamin E
See: Alzheimer's Disease-Part XX-Clinical Trials
See: Alzheimer's Disease-Part XXI- AD and the Brain
See: Alzhemer's Disease-Part XXII-Lewy Bodies Disease
See: Alzheimer's Disease-Part XXIII-HMG
See: Alzheimer's Disease-Part XXIV-A Prequel
See: Alzheimer's Disease-Part XXVI-Amyloid-beta Hypothesis Controversy
See: Alzheimer's Disease-Part XXVII- AD and Diabetes
See: Alzhemeir's Disease-Part XXVIII - Insulin and AD


Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated January 27, 2009

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