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TrialMatch is a free clinical trials matching service that connects individuals with Alzheimer's, caregivers and healthy volunteers to current research studies. Alzheimer's, caregivers and healthy volunteers to current studies.
Clinical trials test new interventions or drugs in a series of steps (or phases) to prevent, detect or treat disease. During this sequence of testing, researchers gradually build evidence about whether an intervention or drug is effective and whether it has an acceptable safety profile — that is, whether the risks associated with its use are reasonable given its potential benefit.
Phases of pharmacological (drug) clinical trials
New drugs must successfully complete a three-phase clinical trial process (Phase I, Phase II and Phase III) before being approved for use by the Food and Drug Administration (FDA); they must perform well enough in each phase to progress to the next one. Preclinical studies in laboratories establish a scientific basis for believing a drug is reasonably safe and potentially effective.
- Phase I trials, the first stage of human testing, typically involve fewer than 100 volunteers and look at the risks and side effects of a drug. Participants at this phase are often healthy volunteers.
- Phase II trials enroll up to a few hundred volunteers who have the condition the drug is designed to treat. These studies provide further information about safety and help to determine the best dosage of a drug, and are generally too small to provide clear evidence about a treatment's benefit.
- Phase III trials enroll several hundred to thousands of volunteers, often at multiple study sites worldwide. They provide the chief evidence for safety and effectiveness that the FDA will consider in deciding whether to approve a drug.
- Phase IV trials, also called post-marketing studies, are often required by the FDA after a drug is approved. During this phase, researchers continue to monitor the health of people taking the medication to gain further insight into its long-term safety and effectiveness.
Criteria to participate
Before joining a clinical trial, an individual must qualify for the study. All clinical trials have guidelines about who can participate. Researchers define these guidelines as inclusion and exclusion criteria. Examples of these criteria include:
- Limiting participants to a certain age range.
- Requiring participants to be in a certain stage of the disease being studied.
- Not allowing health conditions other than the one being studied.
- Not permitting use of certain medications other than the study drug.
- Requiring participation of a caregiver or “study partner.”
Individuals with dementia or those who are at risk of developing it, caregivers, and healthy volunteers with no dementia issues are needed for Alzheimer’s-related clinical trials. To find a study that matches your personal eligibility, visit Alzheimer’s Association TrialMatch®.
Scientists have learned that people sometimes feel better, and even have improved results on medical tests, when they believe a treatment is helping them. Doctors may also convince themselves a treatment is working because they care about their patients.
There are two main strategies to reduce the likelihood that hopes and beliefs will affect the outcome of clinical trials:
- Trials are placebo-controlled. Study participants are randomly chosen to receive the experimental treatment and some receive a placebo, an inactive pill, liquid or powder that has no treatment value. Experimental treatments are often compared to placebos to assess effectiveness.
- Trials are “double-blinded.” Participants and study staff are unaware of who receives the drug and who gets the placebo.
When a standard of care — a typical treatment plan for a condition — is available, it
is often used instead of a placebo. In such cases, the experimental treatment and the
standard treatment are compared.
Although participants and study staff don’t know who’s getting the treatment and
who’s getting the placebo, most trials have a separate, independent Data Safety and
Monitoring Board that has access to this information. Board members
regularly analyze data and step in if they notice any worrisome patterns of serious
Informed consent is the process of learning key facts about a study before deciding
whether to volunteer. The FDA requires potential participants to have complete information about the study in writing. Study staff members are required to meet with each prospective participant to explain risks, possible benefits and answer any questions. People who decide to join the study must sign an informed consent form. Individuals who are invited to participate in a study are not required to join. Participants are free to leave a study at any time.