Clinical Trials

Welcome to our Clinical Trials Page!

Here we hope to educate readers about the world of Clinical Trials. Read an overview below about how Clinical Trials work, or to learn more about specific studies that you or a loved one could participate in by Joining AlzU.org Today!

What Are Clinical Research Trials?

Clinical research - also referred to as clinical research trials, are conducted in order for medical researchers to decipher just which therapies or interventions are the most effective and safe to detect, treat or prevent a disease such as Alzheimer’s disease (AD). Not only do clinical trials look at the effectiveness and risks of specific treatment interventions or drugs, researchers also evaluate other aspects of medical care, such as how to improve the quality of life for people with chronic illness such as AD.

Before a new drug or treatment can be used to treat a disease, it must first be carefully tested in a laboratory, then with live people, in what is called a clinical research trial, in order to evaluate the effectiveness and safety of the drug or treatment.

There is a protocol that is followed for every clinical trial, designed to answer a specific research question, as well as protecting the safety of the participants in the study. A protocol describes exactly who will participate in the trial, which tests and procedures, medications and dosages will be used, as well as how long the study will last, and what type of information will be collected during the study.

The federal government mandates that all clinical trials are governed closely by an Institutional Review Board (IRB) - comprised of a committee of physicians, statisticians and members of the community. The IRB is appointed in order to ensure the risks of the clinical trial are minimal and that potential benefits are worth the risks.

What if I don’t want to take an Experimental Drug, but I do want to Help Advance Alzheimer’s research?
There are a variety of research studies that aim to assess the effectiveness of things other than drugs, like exercise, dietary changes, or even educational strategies (which is why www.AlzU.org was created).

Taking part in a research study does not have to mean that a person needs to take an experimental “drug”, specifically.

Phases of a Clinical Trial

There are several different phases of a clinical trial, each developed in order to help researchers answer different questions. Phases include:

Phase I - an experimental drug or treatment is tested in a small group of between approximately 20 and 80 participants to test a drug or treatment’s safety and identify any side effects
Phase II - an experimental drug or treatment is tested in a larger group of approximately 100 to 300 participants in order to continue to evaluate its safety
Phase III - an experimental drug or treatment is given to a very large group of (on average) approximately 1,000 to 3,000 participants (could be more or less) in order to compare it with standard treatment and gather information on side effects and safety
Phase IV - after the drug has been FDA approved, studies continue in order to track of its long term safety and effectiveness as well as its optimal use

What is a Double Blind Placebo Study?

In a single blind placebo study, participants are NOT aware of whether they receive the real drug being tested or a placebo (“sugar” pill with no therapeutic effect whatsoever). This study reinforces the fact that participants are not subject to being influenced in any way by how they anticipate the reaction to the experimental drug to be. In a single blind study, only the participant is NOT told whether she/he is taking a drug or a placebo. A double blind study involves none of the members of the research team (including the participants) being told which group is getting the investigatory drug or which group will get the placebo.

The Good News Regarding Clinical Trials!

Those who have been newly diagnosed with AD and their caregivers and family members may be very interested to know that there are some great benefits to becoming involved in local research trials. You can learn more by joining AlzU.org, or there are also informative websites designed in order to help participants locate new clinical trials, such as TrialMatch (sponsored by the Alzheimer’s Association), and www.ClinicalTrials.gov. These websites allow users to search according to the disease entity being studied, age group of participants, and geographic area.

Benefits of Becoming Involved in Clinical Trials

The benefits of clinical research trials must be weighed against the risks in order for each participant to decide if the trial is in his/her best interest. There may be serious side effects of any clinical trial (some could even be life threatening). The amount of time required for the trial must also be taken into consideration. Some trials require hospital stays and/or frequent lab tests. The potential benefits and risks of a research study must be explained to all participants before and during the study through a process called “informed consent” before each person involved in the study agrees to participate or continue the study.

After the Research Trial is Complete

Once the clinical trial is complete, the information gathered is examined in detail and then a decision is made regarding moving on to the next phase of the study. If the research reveals that the treatment is ineffective or unsafe, the decision to stop the testing will be made. Results of clinical trials may be published in scientific journals or perhaps featured in the media. Once a new drug or treatment has been deemed safe and effective by clinical trials, it may even be adopted as the standard of care by medical professionals.

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