Clinical Drug Studies
What is a Clinical Drug Study?
A clinical trial is also called a clinical drug study, is research that enables physicians and scientists to determine the safety and effectiveness of new drugs or treatments. The Food and Drug Administration sets strict guidelines and regulations for clinical drug studies, and sponsoring pharmaceutical companies, hospitals, and academic institutions also require that studies be carried out precisely as planned.The Clinical drug study team at UMAC includes physicians, nurses, psychologists and coordinators who work together to make your clinical trial experience safe, informative, and meaningful.
Participating in a Clinical Drug Study
Before entering a clinical drug study, it is the responsibility of the Center staff to make sure you meet the eligibility requirements, and to let you know what the study will involve. This is accomplished by thoroughly discussing the study and answering any questions you may have.
At that point, if you agree to participate, you will be asked to sign an informed consent, which documents the fact that you have chosen to be in the study, after proper review of any information related to your participation in the study.
Even though you have signed the informed consent,your participation is completely voluntary, and you may leave a study at any time you feel is necessary.
Eligibility
While everyone has the potential to participate in a clinical drug study, each trial has specific criteria for participation. Eligibility requirements are set by the sponsoring pharmaceutical company and/or the Federal government, and consequently, we have no flexibility in altering eligibility requirements. If you are not eligible for a current study, there may be an appropriate study for your consideration soon.
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Current Clinical Drug Studies enrolling at our center
Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for Alzheimer's disease.
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients aged 50 to 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years. Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients aged 50 to 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years. Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.
Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease The study consists of a double-blind, double-dummy, parallel-group comparison of 23 mg donepezil SR to the currently marketed formulation, 10 mg donepezil IR, in patients with moderate to severe Alzheimer's disease. A total of approximately 1600 patients will be enrolled to obtain complete data from approximately 1280 completed patients. The study will be performed at approximately 200 global sites (Asia, Oceania, Europe, India, Israel, North America, South Africa and South America).
Memantine (10mg BID) for the Frontal and Temporal Subtypes of Frontotemporal Dementia The primary objective of the study is to determine whether memantine is effective in slowing the rate of behavioral decline in frontotemporal dementia. The secondary objective of the study is to assess the safety and tolerability of long-term treatment with memantine in patients with frontotemporal dementia (FTD) or semantic dementia (SD). To determine whether memantine is effective in slowing the rate of cognitive decline in frontotemporal dementia. To evaluate whether memantine delays or decreases the emergence of parkinsonism in frontotemporal dementia. The tertiary objective of the study is to determine whether treatment with memantine affects changes in weight
Home-Based Assessment for Alzheimer Disease Prevention (HBA) The purpose of this study is to evaluate three methods of performing home-based assessments in Alzheimer's Disease (AD) prevention trials. The initial in-person assessment will be done in the clinic or at home.
The Caregiver Knowledge and Skills Project. A research study being conducted by The University Memory and Aging Center of Case Western Reserve University and University Hospitals Case Medical Center. The goal of the study is to learn how best to help family members of persons with Alzheimer’s disease or other types of dementia increase their knowledge and skills related to caregiving.
A full list of clinical trials throughout the country(enrolling and in progress) is available at www.clinicaltrials.gov
If you have any questions regarding these studies, please call Elaine Ziol at 216-844-6328 or email at elaine.ziol@case.edu
Benefits of Clinical Drug Studies
- Access to new treatments
- Regular contact with medical experts at the University Memory and Aging Center
- Opportunities to contribute to advancements in treatment for Alzheimer's disease now and for future generations
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