ADVANCE Study: Alzheimer Disease eVAluation iN Clinical PracticE

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Elpen Pharmaceutical Co. Inc.
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier:
NCT01772095
First received: January 17, 2013
Last updated: November 20, 2013
Last verified: May 2013
  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


Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: November 2013
Estimated 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

  Show Detailed Description

  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

Contacts
Contact: Antonis Politis, MD, Ass Professor 00302107291388 apolitis@meduoa.gr

Locations
Greece
Aiginition University Hospital Recruiting
Athens, Greece
Principal Investigator: Antonis Politis, MD, Ass Professor         
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: November 20, 2013
Health Authority: Greece: National Organization of Medicines

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

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
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 July 22, 2014