A clinical research study is designed to help researchers understandwhether an investigational drug is safe and effective for humans.

There are usually several phases of studies, each designed to learnmore about the investigational drug’s effects. When a trial is in an early phase the clinical trial may involve very few patients. As more is learned about an investigational drug the size of the studies typically get larger.

All clinical research studies must follow a strict set of rules that areoutlined in the study protocol. These rules set specific requirements on which types of patients can be included in the study, procedures thatmust be followed and the number of required study visits.

Because of these rules, it is important that patients who participatecarefully follow the visit schedule and instructions of the researchpersonnel conducting the studies. Clinical research studies are required for all new drugs because a company needs to show that the drug is safe and effective before it can be made available to the generalpopulation.

Clinical research studies are conducted to answer research questions and to help researchers learn if a certain investigational drug is safe and effective. The main questions the researchers want to answer are:

• Does this investigational drug work?
• What side effects does this investigational drug cause?
• Do the benefits of the investigational drug outweigh the risks?
• Which patients are most likely to find this investigational drughelpful?

Participating in a clinical research study is a voluntary opportunity, and thus, it is always up to you to decide if you and your loved one would like to do so. People participate in clinical research studies fordifferent reasons, some of which may be:

• There is no current approved drug for their disease

• They have not experienced improvement of the condition afterusing the currently approved drug

• They want access to a new type of drug even if it is notguaranteed to be better or as good as already available drugs

• They want to contribute to the development of a new drug forothers with a similar disease

This clinical research study is enrolling adults with agitation inAlzheimer's. If your loved one has symptoms of agitation in Alzheimer's, he/she may be eligible to enter the study. Prior to enrolling in the study, you and he/she will need to understand what is involved in the study, bytalking to the study staff and reading the Informed Consent Form. TheInformed Consent Form outlines all the known safety information of thisinvestigational drug and what is involved in the study.

Once the Informed Consent Form is signed, you and your loved one will visit your study doctor for certain tests to make sure he/she is eligible to be included. Your study doctor and study team will be available to answer any questions that you might have as you go through theprocess.

Everyone in this study will take either the investigational drug or placebo(a pill without active drug, sometimes called a “sugar pill”).

You and your study doctor, and the study staff will not know which drug he/she is taking. A computer program chooses which drug he/she gets at random, like tossing a coin. The results are then compared at theend of the study.

Once your loved one is assigned to a study group he/she will remain on it for the whole study period.

Once your loved one has completed the study they may qualify for an extension study. In this study all patients will receive theinvestigational drug for up to 12 weeks.

The Informed Consent Form will review in detail all of the safety information known about theinvestigational drug. After you read it, please direct any questions to the study doctor.

No. The investigational drug and associated procedures/testing are provided at no cost to clinicalresearch study participants.

Participants in this clinical research study, and their caregivers, may receive reimbursement for travel expenses.

Please sign up to provide your contact information and answer a few questions.