ADVANCE Study: Alzheimer Disease eVAluation iN Clinical PracticE

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier:
NCT01772095
First received: January 17, 2013
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition
Alzheimer Disease
Dementia
Cognitive Disorders

Study Type: Observational
Study Design: Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Elpen Pharmaceutical Co. Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • Number of Adverse Events occured during study duration [ Time Frame: 0, 3 months, 6 months ] [ Designated as safety issue: Yes ]

    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.



Other Outcome Measures:
  • Number of days which the patient has not taken his/her study medication [ Time Frame: 0,3,6 months ] [ Designated as safety issue: No ]
    Compliance to study treatment


Enrollment: 389
Study Start Date: February 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Dementia
Patients diagnosed with dementia and evaluated by specific Alzheimer disease scales

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with dementia

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772095

Locations
Greece
Aiginition University Hospital
Athens, Greece
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
Investigators
Study Director: Paraskevi Sakka, MD Hygeia Hospital, Athens, Greece
Study Director: Vasilios Vagenas, MD Sismanogleio Hospital, Athens, Greece
Study Director: Konstantinos Vadikollias, MD University hospital of Alexandroupolis, Greece
Study Director: Konstantina Giannopoulou, MD Laiko Hospital of Athens, Greece
Study Director: Ioannis Metallinos, MD Patras, Greece
Study Director: Antonios Mougias, MD Athens, Greece
Study Director: Ioannis Papatriantaphyllou, MD Athens, Greece
Study Director: Andreas Tzimos, MD Psychiatry Hospital of Thessaloniki, Greece
Study Director: Xenophon Fitsoris, MD Papageorgiou hospital of Thessaloniki, Greece
Study Chair: Antonis Politis, MD, Associate Professor Aiginition University Hospital of Athens
Study Director: Sokratis G Papageorgiou, MD, Associate Professor Attikon University Hospital
Principal Investigator: Evgenia Katirtzoglou, MD Aiginition University Hospital of Athens
Principal Investigator: Nikolaos Andronas, MD Attikon University Hospital of Athens
Principal Investigator: Eleni Margioti, Psychologist, PhD Hygeia Hospital of Athens
  More Information

Publications:

Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT01772095     History of Changes
Other Study ID Numbers: 2012-DON-EL-33
Study First Received: January 17, 2013
Last Updated: August 18, 2014
Health Authority: Greece: National Organization of Medicines

Keywords provided by Elpen Pharmaceutical Co. Inc.:
Donepezil (Dementis)
Elderly

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014