The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria." These criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What are some common inclusion criteria for clinical trials for neurodegenerative diseases at UCSF?
Here we list some examples of common general criteria for many of the studies that are common at UCSF. Each specific study will have its own set of criteria that may differ from those listed below.
- Age between in the range of 50 to 85 years old. Age ranges can vary slightly from one study to another, but this is a common range.
- A clinical diagnosis of a neurodegenerative disease. This diagnosis is usually made by a neurologist, psychiatrist or geriatrician who has evaluated the patient prior to the study. The diagnosis must be verified by the study doctor, usually at the first visit.
- Cognitive status. Participants in clinical trials must have clear evidence of memory or other similar impairments, but must not be too impaired to perform the tests involved in the study. One common rating scale that physicians use to measure cognitive status is called the Mini-Mental State Exam (MMSE) score. Typically, MMSE scores for clinical trials are in the range of 14 – 26 points out of a maximum of 30. The specific MMSE range often varies considerably from one study to another.
- Having a study partner (spouse, friend, partner, etc.) who has frequent contact with the participant and who is willing to come to the study visits. This criterion is part of most studies because some patients may need assistance to drive or travel to study visits, remember appointments or reliably take their study medication(s). In addition, a caregiver’s opinion about how a study participant is doing is an important component of most studies.
What are some common exclusion criteria for clinical trials for neurodegenerative diseases at UCSF?
- Not stable on dose of FDA-approved medications for neurodegenerative diseases. Most current clinical trials allow subjects to continue to take medications such as donepezil (Aricept®), rivastigmine (Exelon®), galantamine (Razadyne®), memantine (Namenda®), and carbidopa-levodopa (Sinemet®). However, subjects usually must be on stable doses of these medications for between 60 – 120 days prior to beginning a study. A stable dose means that there have been no persistent alterations in the amount of drug taken during that time period. Missing a dose or two will not affect eligibility.
- Presence of another condition that may impact the results of a clinical trial. Common conditions that are considered exclusions for most clinical trials include:dementia other than AD, history of a large stroke, active cancer within 5 years, atrial fibrillation, heart failure, kidney failure, recent major surgery, severe psychiatric disease.
- Medications that may impact the results of a clinical trial. These often include blood thinners such as warfarin and medicines that have the potential to impair memory such as anti-epileptic drugs.
- Not able to undergo an MRI scan. Many trials use MRI scans to monitor for safety or effectiveness of a new drug. If you have a pacemaker or other metal in your body that would preclude an MRI scan this may limit your ability to participate in some studies.