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Alzheimers
Clinical Study:
ALZHEIMER'S (pg 2 of 7)
ACTUAL CLINICAL STUDY:
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A New Therapeutic Approach for Improving Dementia of the ALZHEIMER TYPE

by Jorg G. D. Birkmayer, M.D., Ph.D
Forschungs-und Lehreinrichtung des Birkmayer Instituts fur Parkinsontherapie, Vienna, Austria


ABSTRACT:
The coenzyme nicotinamide adenine dinucleotide (NADH) has been used as mediation in patients suffering from dementia of the Alzheimer type in an open label trial.

In all patients evaluated so far, an improvement in their cognitive dysfunction was observed.

Based on the minimental state examination, the minimum improvement was 6 points and the maximum improvement 14 points with a mean value of 8.35 points. The improvement on the basis of the global deterioration scale (GDS) was a minimum of 1 point and a maximum of 2 points with a mean value of 1.82. The duration of therapy was between 8 and 12 weeks. No side effects or adverse effects have been reported from the patients or their caregivers during the observation period which is, in some patients, more than a year. This open label trial represents a pilot study from which no definitive conclusion can be drawn. A double-blind placebo controlled study is necessary to demonstrate the clinical efficacy of NADH. The planning and the fulfillment of all requirements for such a study are in progress.

INTRODUCTION:
Dementia can be defined as loss of intellectual functions such as thinking, remembering, and reasoning of sufficient severity to interfere with the person’s daily functioning. It cannot be defined as a disease itself but rather a variety of symptoms which may accompany the physical conditions or diseases. The cause and rate of progression of dementia varies. The most well-known disease accompanied with progressing dementia is Alzheimer’s disease. However, there are other diseases which are accompanied with dementia, such as Huntington disease, Pick’s disease, Parkinson disease and multi-infarct dementia. Further conditions which may induce dementia are head injuries, hydrocephalus, meningitis, brain tumor, nutritional deficiencies, and drug reactions. The most common of the dementing disorders is Alzheimer disease affecting as many as four million Americans. Approximately 5 percent of the population over 65 years is affected. The symptoms begin slowly, then progress until the patient is completely dependent on his or her family or caregiver (
footnote: 1 ). This dependence becomes an emotional, physical, and financial burden.

These burdens have generated tremendous interest in the definition of the etiological, biochemical, pathological, diagnostic, and treatment possibilities associated with this condition. Many labels have attached to the clinical profile of dementia. The clinical profile of dementia consists of (1) loss of memory, (2) deterioration of intellectual functioning, and (3) impairment in the activities of daily living ( 2 ). Symptoms of this disease include a gradual memory loss, decline in ability to perform routine tasks, disorientation in time and space, impairment of judgment, personal change, difficulty in learning, and loss of communication skills.

A work group established by the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer’s Disease and Related Disorders Association (ADRDA) published clinical criteria for the diagnosis of Alzheimer’s disease, a brain disorder marked by progressive dementia, in 1984. The NINCDS-ADRDA Work Group’s diagnostic criteria have become the criteria most universally accepted. There is general agreement on the pathology and biochemistry of Alzheimer’s disease ( 3 ). Unfortunately, the pathology can be determined only after death by means of a brain autopsy. A brain autopsy of an Alzheimer’s patient will show the presence of (1) corticalatrophy, (2) neuron loss, and (3) senile plaques and neurofibrillary tangles. A definitive diagnosis of Alzheimer disease is therefore possible through histopathological examination of the brain tissue. As this cannot be done during the treatment period when patients are still alive, the term senile dementia of the Alzheimer type (SDAT) will be used in the following.


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