Alzheimer Disease Clinical Trial
Official title:
A 6 Months, Prospective, Open-label, Observational, Non-interventional Clinical Trial to Examine the Efficacy and Safety of Donepezil (Dementis®) Administration in Patients With Dementia.
In 1906, Dr. Alois Alzheimer first described the disease that later took his name. Today,
100 years later, 24 million people worldwide suffer from Alzheimer's disease or other
dementias.
The term 'dementia' is clinical and is used to describe brain disorders that cause decline
in mental functions, memory first and then speech, judging and overall behavior. Alzheimer's
disease is by far the most common form of dementia, followed by vascular dementia, dementia
with Lewy, the frontotemporal dementias etc.
In Greece there are 141,000 patients with dementia. With increasing life expectancy, the
figures are expected to increase dramatically in the future.
Alzheimer's disease is the most common form of dementia, as well as 50-60% of patients with
dementia suffer from this disease. The second most common type of dementia is vascular, ie
that associated with cerebrovascular disease and is the 15-30% of all dementia cases and is
most common between the ages of 60-70 years and is more common in men than women. It is
estimated that 5% to 8% of people over 65 suffer from dementia, while in industrialized
countries ranges at the following levels :15-25% over 85 and 32% over 90 years.
Dementia is characterized by a slow onset and progressive course. The syndrome includes
disorders in general intelligence, learning and memory, problem solving, perception,
judgment, executive function, language and synergy of movement, but without impairment of
consciousness.
Alzheimer's disease is a neurodegenerative disorder with distinct clinical and
histopathological features, although with variations from person to person.
In its early stages it is sometimes difficult to diagnose cognitive impairment from normal
aging of the brain. With the passage of time, the continuous decline in recent memory,
fluency, ability for spatial orientation ultimately restricts the autonomy regarding basic
activities of daily life such as managing finances. The anxiety and depression complicate
diagnosis in early stages, but gradually decline with loss of sensitivity. Intermediate
stages of the disease require increasingly supervision in daily self-care activities, such
as personal hygiene and clothing. In the advanced stages are usually essential nursing care
in institutional context.
The severity of symptoms of the disease varies and is determined by premorbid factors such
as education, gender, cultural background. Epidemiological studies have shown as protective
factors against the onset of dementia, higher education, taking estrogen and
anti-inflammatory drugs. On the other hand, age, family history of dementia, head injury,
hypertension and Down syndrome are risk factors for developing the disease. Finally, some
genetic factors appear to be protective, and other pressures to the disease.
Current treatments aim to control the symptoms of the disease. Important parameter is the
early diagnosis and early care. The delay in onset of symptoms five years would reduce the
incidence of disease by 50% per generation, while complementary therapies and delay entry
into institutions would reduce costs considerably. This is the rationale of medication,
currently until it causative treatment. The cost of dementia to society as intolerable by
the year 2030 it is estimated that a 20% of the population will be over 65. Thus e.g. cost
of $ 15 billion currently available in the U.S. for the care of people with dementia are
likely to rise further.
Challenge of tackling Alzheimer disease is slowing the degenerative disease process,
influencing with any pharmaceutical interventions in various parameters involved in the
degeneration of the neuron, resulting in no further for a short-time-charge of the patient's
cognition and - the possible load-relief of the family.
Cholinesterase inhibitors are now a documented, effective treatment of the symptoms of
Alzheimer disease and therefore are appropriate pharmaceutical intervention. Donepezil has
been shown to help and behavioral problems of dementia.
Aging and Dementia Aging as a biological phenomenon leads to irreversible morphologic
changes in all body systems. The changes are related to the nervous system can eventually
lead to dementia. The population of elderly people is increasing in all developed countries,
thereby creating a variety of social, economic and mainly medical problems. This finding has
brought interest has to those pathological conditions which are manifested by symptoms that
have some qualitative similarity to those of old age and thus both contribute to further
expansion in the number of this group of the population and also create diagnostic problems.
Morphological, neurochemical and neuropsychological changes that occur in normal aging and
dementia observed, especially in Alzheimer.
Dementias are costly illnesses. In Europe today, the cost of care for people with dementia
exceeds the cost of illnesses such as heart disease, cancer and strokes.
The last 20 years have been tremendous advances in the prevention, diagnosis and treatment
of dementia.
Have significantly increased our knowledge of the predisposing factors of the disease, which
helps to prevent. The control of vascular risk factors (hypertension, obesity, diabetes
mellitus, hypercholesterolemia, smoking) is beneficial for both the brain and the
cardiovascular system. Diet low in fat, fish and vegetarian consumption associated with
decreased risk of Disease Alzheimer.
The diagnosis at early clinical stages is possible. An experienced physician can diagnose
Alzheimer's with certainty up to 90% by combining the diagnostic tools at his disposal
(neuroimaging methods, biomarkers, genetic testing). The pathological process in the brain
of patients with Alzheimer's disease begins decades before the appearance of clinical
symptoms. The etiology is probably multifactorial. Today intensively sought ways
identification of candidate patients and investigated the possibility of non-specific
factors (such as hormones, antioxidant vitamins, or anti-inflammatory agents) can reverse or
delay the pathogenic process.
Intercultural, people less educated the incidence of dementia is greater. Specially-designed
studies have shown that continuing education in adulthood increases cognitive reserve and
probably protects against dementia. Those who exercised spiritually (studying, reading)
suffer Alzheimer's disease less frequently or in a milder form. Physical exercise and
fitness also contribute significantly to the prevention of dementia.
Today's symptomatic treatment of Alzheimer disease . Our experience with drugs called
angiotensin cholinesterases (ARICEPT, EXELON, REMINYL) as with the NMDA antagonist (EBIXA)
demonstrated that early initiation of treatment significantly slows disease progression
Alzheimer, and other dementia syndromes (Vascular and mixed dementia, dementia with Lewy
bodies and Alzheimer's Dementia Parkinson).
There is also the non-drug approach the patient exercises involving memory and attention,
cognitive empowerment programs, therapy memories orientation to reality. Knowledge
empowerment programs aimed at the exploitation of the cognitive functions of patients who
remain at a satisfactory level. By using a wide variety of stimuli and specialized methods
appropriately stimulated brain of patients and achieve the desired result.
The dementia in the early stages is not easy to diagnose because the public confuses the
symptoms to those of normal aging. Still prevalent misconception that nothing can help these
patients.
Recent studies have shown that demented patients are usually examined by a specialist 3
years after experiencing the first symptoms of the disease. This delay in diagnosis and
treatment has a negative impact on the progress of the disease. Accurate and early diagnosis
of dementia, ensure early intervention, smoother transition stages of the disease and a
better quality of life for patients and their families for a longer period of time. It also
allows further targeted prevention and treatment strategies, medical or otherwise.
;
Time Perspective: Prospective
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