Alzheimer DiseaseADVANCENCT01772095
ADVANCE Study: Alzheimer Disease eVAluation iN Clinical PracticE
An observational study of Alzheimer Disease and Dementia, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Alzheimer Disease, Dementia, Cognitive Disorders
- How many people
- 389 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2013to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with dementia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
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.
- Conditions
- Alzheimer Disease, Dementia, Cognitive Disorders
- Keywords
- Donepezil (Dementis), Elderly
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Dementia | Patients diagnosed with dementia and evaluated by specific Alzheimer disease scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alzheimer Disease Evaluation Scales (MMSE, Clock test, IADL)from baseline until the end of the study
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.
Measured: -1, 0, 3 months, 6 months
Secondary outcomes (1)
Number of Adverse Events occured during study duration
Reporting of adverse events during the study period. Safety 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.
Measured: 0, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paraskevi Sakka, MD, Study director, Hygeia Hospital, Athens, GreeceVasilios Vagenas, MD, Study director, Sismanogleio Hospital, Athens, GreeceKonstantinos Vadikollias, MD, Study director, University hospital of Alexandroupolis, GreeceKonstantina Giannopoulou, MD, Study director, Laiko Hospital of Athens, GreeceIoannis Metallinos, MD, Study director, Patras, GreeceAntonios Mougias, MD, Study director, Athens, GreeceIoannis Papatriantaphyllou, MD, Study director, Athens, GreeceAndreas Tzimos, MD, Study director, Psychiatry Hospital of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772095
- Sponsor's protocol ID
- 2012-DON-EL-33
- Acronym
- ADVANCE
- Status last verified
- Aug 2014
- First submitted
- 17 Jan 2013
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lopez-Pousa S, Bermejo-Pareja F, Frank A, Hernandez F, Leon T, Rejas-Gutierrez J; ECO. [The effect of donepezil in comparison with conventional treatment on cognitive functioning and the performance of the patient in a prospective cohort of patients with Alzheimer's disease treated in routine clinical practice in Spain]. Rev Neurol. 2010 Nov 16;51(10):577-88. Spanish.
PubMed 21069636Boada-Rovira M, Brodaty H, Cras P, Baloyannis S, Emre M, Zhang R, Bahra R; 322 Study Group. Efficacy and safety of donepezil in patients with Alzheimer's disease: results of a global, multinational, clinical experience study. Drugs Aging. 2004;21(1):43-53. doi: 10.2165/00002512-200421010-00004.
PubMed 14715043Doody RS, Corey-Bloom J, Zhang R, Li H, Ieni J, Schindler R. Safety and tolerability of donepezil at doses up to 20 mg/day: results from a pilot study in patients with Alzheimer's disease. Drugs Aging. 2008;25(2):163-74. doi: 10.2165/00002512-200825020-00008.
PubMed 18257603Malouf R, Birks J. Donepezil for vascular cognitive impairment. Cochrane Database Syst Rev. 2004;2004(1):CD004395. doi: 10.1002/14651858.CD004395.pub2.
PubMed 14974068Johannsen P, Salmon E, Hampel H, Xu Y, Richardson S, Qvitzau S, Schindler R; AWARE Study Group. Assessing therapeutic efficacy in a progressive disease: a study of donepezil in Alzheimer's disease. CNS Drugs. 2006;20(4):311-25. doi: 10.2165/00023210-200620040-00005.
PubMed 16599649Black SE, Doody R, Li H, McRae T, Jambor KM, Xu Y, Sun Y, Perdomo CA, Richardson S. Donepezil preserves cognition and global function in patients with severe Alzheimer disease. Neurology. 2007 Jul 31;69(5):459-69. doi: 10.1212/01.wnl.0000266627.96040.5a.
PubMed 17664405Birks J, Harvey RJ. Donepezil for dementia due to Alzheimer's disease. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD001190. doi: 10.1002/14651858.CD001190.pub2.
PubMed 16437430Matthews HP, Korbey J, Wilkinson DG, Rowden J. Donepezil in Alzheimer's disease: eighteen month results from Southampton Memory Clinic. Int J Geriatr Psychiatry. 2000 Aug;15(8):713-20. doi: 10.1002/1099-1166(200008)15:83.0.co;2-i.
PubMed 10960883Gauthier S, Feldman H, Hecker J, Vellas B, Ames D, Subbiah P, Whalen E, Emir B; Donepezil MSAD Study Investigators Group. Efficacy of donepezil on behavioral symptoms in patients with moderate to severe Alzheimer's disease. Int Psychogeriatr. 2002 Dec;14(4):389-404. doi: 10.1017/s104161020200858x.
PubMed 12670060Tricco AC, Vandervaart S, Soobiah C, Lillie E, Perrier L, Chen MH, Hemmelgarn B, Majumdar SR, Straus SE. Efficacy of cognitive enhancers for Alzheimer's disease: protocol for a systematic review and network meta-analysis. Syst Rev. 2012 Jun 28;1:31. doi: 10.1186/2046-4053-1-31.
PubMed 22742585Tariot P, Salloway S, Yardley J, Mackell J, Moline M. Long-term safety and tolerability of donepezil 23 mg in patients with moderate to severe Alzheimer's disease. BMC Res Notes. 2012 Jun 8;5:283. doi: 10.1186/1756-0500-5-283.
PubMed 22681723Isik AT, Yildiz GB, Bozoglu E, Yay A, Aydemir E. Cardiac safety of donepezil in elderly patients with Alzheimer disease. Intern Med. 2012;51(6):575-8. doi: 10.2169/internalmedicine.51.6671. Epub 2012 Mar 15.
PubMed 22449664Rungsanpanya T, Muangpaisan W, Praditsuwan R. Clinical practice with antidementia drugs in a geriatric clinic. J Med Assoc Thai. 2012 Aug;95(8):1081-9.
PubMed 23061314Isik AT, Bozoglu E, Yay A, Soysal P, Ateskan U. Which cholinesterase inhibitor is the safest for the heart in elderly patients with Alzheimer's disease? Am J Alzheimers Dis Other Demen. 2012 May;27(3):171-4. doi: 10.1177/1533317512442999.
PubMed 22573283Bond M, Rogers G, Peters J, Anderson R, Hoyle M, Miners A, Moxham T, Davis S, Thokala P, Wailoo A, Jeffreys M, Hyde C. The effectiveness and cost-effectiveness of donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease (review of Technology Appraisal No. 111): a systematic review and economic model. Health Technol Assess. 2012;16(21):1-470. doi: 10.3310/hta16210.
PubMed 22541366
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01772095
- Acronym / sponsor ID
- ADVANCE / 2012-DON-EL-33
- Conditions
- Alzheimer Disease, Dementia, Cognitive Disorders
- Keywords
- Donepezil (Dementis), Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Dementia | – | –Patients diagnosed with dementia and evaluated by specific Alzheimer disease scales |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dementia
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Number of Adverse Events occured during study duration
Time frame: 0, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- Background: PubMed 21069636Lopez-Pousa S, Bermejo-Pareja F, Frank A, Hernandez F, Leon T, Rejas-Gutierrez J; ECO. [The effect of donepezil in comparison with conventional treatment on cognitive functioning and the performance of the patient in a prospective cohort of patients with Alzheimer's disease treated in routine clinical practice in Spain]. Rev Neurol. 2010 Nov 16;51(10):577-88. Spanish.
- Background: PubMed 14715043Boada-Rovira M, Brodaty H, Cras P, Baloyannis S, Emre M, Zhang R, Bahra R; 322 Study Group. Efficacy and safety of donepezil in patients with Alzheimer's disease: results of a global, multinational, clinical experience study. Drugs Aging. 2004;21(1):43-53. doi: 10.2165/00002512-200421010-00004.
- Background: PubMed 18257603Doody RS, Corey-Bloom J, Zhang R, Li H, Ieni J, Schindler R. Safety and tolerability of donepezil at doses up to 20 mg/day: results from a pilot study in patients with Alzheimer's disease. Drugs Aging. 2008;25(2):163-74. doi: 10.2165/00002512-200825020-00008.
- Background: PubMed 14974068Malouf R, Birks J. Donepezil for vascular cognitive impairment. Cochrane Database Syst Rev. 2004;2004(1):CD004395. doi: 10.1002/14651858.CD004395.pub2.
- Background: PubMed 16599649Johannsen P, Salmon E, Hampel H, Xu Y, Richardson S, Qvitzau S, Schindler R; AWARE Study Group. Assessing therapeutic efficacy in a progressive disease: a study of donepezil in Alzheimer's disease. CNS Drugs. 2006;20(4):311-25. doi: 10.2165/00023210-200620040-00005.
- Background: PubMed 17664405Black SE, Doody R, Li H, McRae T, Jambor KM, Xu Y, Sun Y, Perdomo CA, Richardson S. Donepezil preserves cognition and global function in patients with severe Alzheimer disease. Neurology. 2007 Jul 31;69(5):459-69. doi: 10.1212/01.wnl.0000266627.96040.5a.
- Background: PubMed 16437430Birks J, Harvey RJ. Donepezil for dementia due to Alzheimer's disease. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD001190. doi: 10.1002/14651858.CD001190.pub2.
- Background: PubMed 10960883Matthews HP, Korbey J, Wilkinson DG, Rowden J. Donepezil in Alzheimer's disease: eighteen month results from Southampton Memory Clinic. Int J Geriatr Psychiatry. 2000 Aug;15(8):713-20. doi: 10.1002/1099-1166(200008)15:83.0.co;2-i.
- Background: PubMed 12670060Gauthier S, Feldman H, Hecker J, Vellas B, Ames D, Subbiah P, Whalen E, Emir B; Donepezil MSAD Study Investigators Group. Efficacy of donepezil on behavioral symptoms in patients with moderate to severe Alzheimer's disease. Int Psychogeriatr. 2002 Dec;14(4):389-404. doi: 10.1017/s104161020200858x.
- Background: PubMed 22742585Tricco AC, Vandervaart S, Soobiah C, Lillie E, Perrier L, Chen MH, Hemmelgarn B, Majumdar SR, Straus SE. Efficacy of cognitive enhancers for Alzheimer's disease: protocol for a systematic review and network meta-analysis. Syst Rev. 2012 Jun 28;1:31. doi: 10.1186/2046-4053-1-31.
- Background: PubMed 22681723Tariot P, Salloway S, Yardley J, Mackell J, Moline M. Long-term safety and tolerability of donepezil 23 mg in patients with moderate to severe Alzheimer's disease. BMC Res Notes. 2012 Jun 8;5:283. doi: 10.1186/1756-0500-5-283.
- Background: PubMed 22449664Isik AT, Yildiz GB, Bozoglu E, Yay A, Aydemir E. Cardiac safety of donepezil in elderly patients with Alzheimer disease. Intern Med. 2012;51(6):575-8. doi: 10.2169/internalmedicine.51.6671. Epub 2012 Mar 15.
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Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paraskevi Sakka, MD study director
Hygeia Hospital, Athens, Greece
Vasilios Vagenas, MD study director
Sismanogleio Hospital, Athens, Greece
Konstantinos Vadikollias, MD study director
University hospital of Alexandroupolis, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01772095, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2014.