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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 389
- Locations
- 1
- Primary Endpoint
- Change in Alzheimer Disease Evaluation Scales (MMSE, Clock test, IADL)from baseline until the end of the study
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 50 and older
- •Diagnosis of dementia
- •Rating 15<MMSE<24
- •The patient has reliable caregivers
- •Signed consent form to participate in the study after informed by reliable caregivers of the patient or another witness
- •The patient is on treatment with donepezil for at least one month prior to joining the clinical trial
Exclusion Criteria
- •Severe gastrointestinal, kidney, hepatic, endocrine, pulmonary, or hematologic disease.
- •Other primary psychiatric or neurological disorder.
- •Clinically significant laboratory and ECG abnormalities.
- •Participation in another clinical study than this
- •Refusal to sign the consent form to participate in the study after informed by reliable caregivers of the patient or another witness
- •The patient is on treatment with donepezil for less than a month before its integration in the clinical study
Outcomes
Primary Outcomes
Change in Alzheimer Disease Evaluation Scales (MMSE, Clock test, IADL)from baseline until the end of the study
Time Frame: -1, 0, 3 months, 6 months
Efficacy of Donepezil (Dementis) treatment MMSE - MiniMental Scale Examination will be performed to all patients for dementia's stage assessment. The mini-mental state examination (MMSE) is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is commonly used in medicine to screen for dementia. It is also used to estimate the severity of cognitive impairment and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. Clock Drawing Test will be performed to all patients during study visits. IADL (Instrumental Activities of Daily Life Living) scale will be used during all study visits.
Secondary Outcomes
- Number of Adverse Events occured during study duration(0, 3 months, 6 months)