A Clinical Trial to Learn More About an Investigational Treatment for Mild to Moderate Alzheimer’s Disease

Through clinical research, scientists and doctors can determine whether a new medical strategy, drug, or device is safe and effective for people. New treatments cannot be discovered without clinical trials, which rely on potential trial participants like you to evaluate the safety and effectiveness of these treatments. Participation in a clinical trial is voluntary. Trial participants should have the intention to complete the trial, but they may leave the trial at any time after they join without penalties of any kind.

Clinical trials help determine the safety and effectiveness of investigational treatments. A research plan, also called a protocol, is created before the trial starts. The protocol describes who can join the trial, what investigational treatments the participants will receive, what questions the researchers will seek to answer, how long the trial will last, and how participant privacy and safety will be protected during the trial.

A clinical trial may compare a new treatment to current treatment options, to a placebo (an identical-looking drug with no active ingredient), or to no intervention at all. Before you decide to join a clinical trial, the trial team will explain all of the trial details.

When an investigational drug is being tested in a clinical trial, (a trial drug) it is tested in stages, or “phases.” Each phase is designed to learn more about whether and how the trial drug works and how safe it is.

Drugs that enter Phase 2 trials have already had information gathered about their safety, usually in small numbers of people. In a Phase 2 trial, the trial drug is studied in a larger group of people so researchers can learn more about the safety of the trial drug, including any side effects people might have when they take it. Phase 2 trials also help researchers begin to learn whether a trial drug may work as a treatment for a specific disease or condition, and which dose(s) of the trial drug should be studied further.

Phase 3 trials usually include large numbers of participants. Some Phase 3 trials are conducted in multiple countries and include thousands of people. Phase 3 trials are used to collect even more information about how safe a trial drug is and whether and how well it works.

A Phase 2/3 trial combines aspects of Phase 2 and Phase 3 into a single clinical trial plan. This allows the trial drug to move more efficiently from one phase to the next.

A placebo is a treatment that looks exactly like the trial drug but contains no active ingredients. In clinical trials, researchers often compare an investigational treatment with a placebo. All of the participants receive the same level of care, regardless of whether they are assigned to receive the trial drug or the placebo – the only difference is whether they actually receive the trial drug. This helps researchers better evaluate the true effects of the trial drug.

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this website by clicking the “Get Started” button.

Trial participants should have the intention to complete the trial, but they may leave the trial at any time after they join. Trial participants have the right to drop out of the trial for any reason or no reason at all. The trial doctor or sponsor also has the right to discontinue a trial participant at any time for the participant’s safety or if the participant no longer meets the trial requirements.

The trial doctor and other site staff will collect your personal information. This may include:

• Your name, address, telephone number, and health insurance number, where applicable
• Your age and sex
• Your lifestyle information
• Your medical history details
• Your response to study treatment
• Data resulting from testing your biological samples

You can learn more about this trial at this web site: clinicaltrials.gov