Introduction to Stages of Research and Clinical Trials

Brian S. Appleby, M.D.Associate Professor of Neurology

University Hospitals Case Medical Center

• Basic Science• Natural History• Biomarker Detection• Development of Diagnostic Tests• Treatment Studies– Pharmacological– Non-pharmacological

Types of Research

• Send prior medical records• Physical examination• Cognitive testing (paper and pencil testing)• Informant interviews• Blood and/or spinal fluid tests• Brain scans• Follow-up in certain time intervals• Engage in some type of intervention

Things You May Be Asked to Do

• Your diagnosis (e.g., Alzheimer’s disease)• Your medications• Your other medical conditions• What is the purpose of the study?• What are the time requirements?• What kind of engagement is required from you?• If a treatment study, is it randomized and placebo

controlled? Do you get an option of taking the medication after the study is completed?

What You Need to Know

Clinical Trial Phases

Appleby BS & Lamb B. Cleveland Alzheimer's Association Update 2013

• Ask your doctor and the Alz Assoc• Alz Assoc TrialMatch, alz.org/trialmatch• NIH, clinicaltrials.gov• UH, uhhospitals.org/clinical-research• CCF, clevelandclinic.org/brainhealthtrials

Places to Find Research Studies

• TauRx (FTD)• SNIFF (intranasal insulin for MCI and AD)• A4 (treatment in asymptomatic AD)• Isotretinoin (AD)• ADNI (Neuroimaging in AD)• Cataracts in dementia• FDA diagnostic study for sCJD (sCJD, AD, FTD)

University Hospitals Trials