Do you have a loved one who you would like to participate in a research study evaluating an investigational drug for agitation related to Alzheimer’s disease?
Because there are no approved long-term treatments for managing agitation in adults with Alzheimer’s, your loved one is more likely to have verbal or physical confrontations. It can be a test of your patience when a loved one with ALZHEIMER’S shows signs of AGITATION. One minute they’re pleasant and the next they’re emotionally distressed, restless, or aggressive. You do what you can to settle them down, but it’s not easy.
We are inviting you to learn more about a research study for agitation related to Alzheimer’s disease. All study-related visits, tests, and study drugs will be provided at no cost. In addition, reimbursement for study-related travel expenses may be provided. No health insurance is required.
The Brex AAD Study is evaluating an investigational drug that is being developed for the treatment of agitation related to Alzheimer’s disease.
The investigational drug has not been approved to treat agitation related to Alzheimer’s disease. However, the drug has been approved to treat adults with major depressive disorder (MDD) when it is taken in combination with antidepressants.
The results of this study will provide more information about the investigational drug and whether it could one day be a potential treatment option for agitation related to Alzheimer’s disease.
To pre-qualify for this study, patients must:
- Be between 55 and 90 years of age
- Have been diagnosed with Alzheimer’s disease
- Show signs of agitation (emotionally distressed, restless, or aggressive)
- Have a caregiver who can participate in the study with them and accompany them to visits
Sign Up
What happens if I sign up? We will match your loved one to a research study location in your area that needs volunteers with agitation related to Alzheimer’s disease or notify you when one becomes available. The study team will then contact you and you may have the opportunity to participate if qualified.
If you think you might like to have your loved one participate in the Brex AAD Study or would like more information, please enter the required information below so we can see if they qualify and can contact you about the study. Keep in mind that participation is entirely voluntary. If you do decide to take part in a study, you may change your mind about participating at any time.
About Agitation in Alzheimer’s Disease
It is estimated that 5.4 million Americans have Alzheimer’s disease, and future projections estimate that, due to an increase in the aging population, there will be approximately 13.8 million Americans with Alzheimer’s disease by 2050. Fourteen percent of people aged 71 and older in the United States (US) have dementia and Alzheimer's disease accounts for an estimated 60% to 80% of cases.1
Agitation can be present from the early stages and throughout the course of Alzheimer’s disease, and symptoms usually become more consequential as the disease progresses.
The presence of agitation in subjects with Alzheimer’s dementia places a significant burden not only on subjects and their caregivers but also on the healthcare system. Additionally, aggressive behaviors such as combativeness, destroying property, and being a danger to oneself and others are significant predictors of time to nursing home placement.2
Currently, there are no approved treatments in the US for the management of agitation in patients with Alzheimer’s disease.
The Brex AAD Study is evaluating an investigational drug that is being developed for the treatment of agitation related to Alzheimer’s disease.
Frequently Asked Questions
What is a research study?
Research studies help pharmaceutical companies learn more about investigational drugs before they are made available to the public. The results of this research study will provide more information about the investigational drug and its potential as a possible treatment for agitation related to Alzheimer’s disease. By taking part in this study, you and your loved one will contribute to agitation related to Alzheimer’s disease treatment research.
Why are research studies important?
A research study is the process by which new and innovative medications, interventions and treatments are approved and brought to market, so people can live happier and healthier lives. Even over-the-counter medications, such as NSAIDs, you may have used to counteract a headache, have gone through the clinical research study process before it was available at your local pharmacy.
What is the purpose of the Brex AAD Study?
The Brex AAD Study is evaluating an investigational drug that is being developed for the treatment of agitation related to Alzheimer’s disease.
The study will compare the investigational drug to placebo, which looks like the investigational drug, but contains no active ingredient. The investigational drug has not been approved to treat agitation related to Alzheimer’s disease. However, the drug has been found to be safe in patients and approved to treat adults with schizophrenia. It has also been approved to treat adults with major depressive disorder (MDD) when it is taken in combination with antidepressants.
The results of this study will provide more information about the investigational drug and whether it could one day be a potential treatment option for agitation related to Alzheimer’s disease.
At the end of the study, patients may have the opportunity to participate in an extension study in which all patients will receive the investigational drug.
What will the Brex AAD Study involve?
Eligible patients will be randomly assigned (like tossing a coin) to receive either the investigational drug or placebo. Patients have a 2 in 3 chance of receiving the investigational drug and a 1 in 3 chance of receiving placebo.
To prevent opinions about the study drug from affecting the study results, the study is designed so that patients, the study doctor, and the study staff will not know the study drug assignments. However, in the event of an emergency, this information can be provided.
Patients will take their study drug once a day for 12 weeks. Patients and their caregivers will also be asked to visit the study clinic up to 9 times for tests and evaluations. Total study participation will last between 16 and 22 weeks, which includes screening for eligibility, study visits, and follow-up.
Will I be reimbursed?
Patients who qualify to take part in the study may receive reimbursement for travel. Please discuss this with the study team when they contact you. Travel reimbursement may be provided to both the patient and caregiver if required.
Is there a cost to participate?
There is no cost to participate in the Brex AAD Study. If you decide to take part:
- Patients will receive study-related care throughout the study from a team of experienced doctors, nurses, and research staff.
- All study-related visits, tests, and study drugs will be provided at no cost.
What else do I need to consider?
The research team will be able to explain more about what the Brex AAD Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
How far is the study site?
We match you to a study site within a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep you and your loved one in our database and reach out once a study in your area becomes available.
About the Brex AAD Study
The Brex AAD Study will enroll about 330 patients who experience agitation with Alzheimer’s disease at approximately 80 sites worldwide.
Patients and their caregivers will be asked to visit the study clinic up to 9 times for tests and evaluations. Total study participation will last between 16 and 22 weeks, which includes screening for eligibility, study visits, and follow-up.
All study-related visits, tests, and study drugs will be provided at no cost. In addition, reimbursement for study-related travel may be provided to both the patient and the caregiver. No health insurance is required.
Who can take part in the Brex AAD Study?
To pre-qualify for the Brex AAD Study, patients must:
- Be between 55 and 90 years of age
- Have been diagnosed with Alzheimer’s disease
- Show signs of agitation (emotionally distressed, restless, or aggressive)
- Have a caregiver who can participate in the study with them and accompany them to visits
All study-related care is provided by a team of dedicated doctors and nurses.
The Brex AAD Study is evaluating an investigational drug that is being developed for the treatment of agitation related to Alzheimer’s disease.