Changes in behavior are some of the more difficult Alzheimer’s symptoms to deal with.
If you or a loved one are experiencing agitation associated with dementia of the Alzheimer’s type, a clinical research study may be right for you.
About the Study
Physicians are studying an investigational treatment for agitation in participants with Alzheimer’s disease.
Eligibility Requirements
Are you or a loved one at least 50 years old and have agitation associated with Alzheimer’s disease?
Participating Locations
This clinical research study will take place at sites around the world. Find a participating study location near you.
Who is Eligible to Participate in this Clinical Research Study?
To qualify, you or a loved one must:
Be at least 50 years old.
Have been diagnosed with Alzheimer’s disease.
Agitation & Alzheimer’s Disease
What is Agitation Associated with Dementia of the Alzheimer’s Type?
Alzheimer’s disease is a progressive disease that slowly destroys nerve cells in the brain which affect memory and thought processes, resulting in a continuing decline in performing daily activities. It is characterized by non-cognitive, behavioral, or psychiatric symptoms, which are seen in 90% of individuals with dementia.
Agitation is a behavioral condition that people with any type of dementia can experience. For individuals with the type of dementia caused by Alzheimer’s disease, agitation is quite common, with over half of patients experiencing it.1
Common symptoms of agitation may include:
Restlessness
Emotional distress
1Jones E, Aigbogun MS, Pike J, Berry M, Houle CR, Husbands J. Agitation in Dementia: Real-World Impact and Burden on Patients and the Healthcare System. J Alzheimers Dis. 2021;83(1):89-101. doi: 10.3233/JAD-210105. PMID: 34250934; PMCID: PMC8461728
About the Clinical Research Study
This clinical research study is evaluating an investigational drug, Masupirdine (SUVN-502), in adults ages 50 years or older who experience agitation associated with dementia of the Alzheimer’s type.
The purpose of this clinical research study is to test how well Masupirdine (SUVN-502) treats agitation associated with dementia of the Alzheimer’s type, learn about the safety of the study drug, and see how well you or your loved one tolerate(s) a once-a-day oral dose.
About the Study Drug Masupirdine (SUVN-502)
Masupirdine (SUVN-502) works by blocking a type of receptor for serotonin (serotonin receptor subtype 6 (5-HT6 receptor)) that affects the actions of dopamine and norepinephrine in the brain. Dopamine and norepinephrine are the substances in the brain that play a role in the control of mood, behavior, and aggression. In Alzheimer’s disease, the brain has altered the activity of these substances.
In this clinical research study, participants have a 66.6% (2 out of 3) chance of receiving Masupirdine (SUVN-502) versus the placebo which has no active ingredient and is used to compare the effects of the study drug.
What to Expect During the Clinical Research Study
If you or a loved one take part in this clinical research study, the participant must have a caregiver accompany them to all visits, assist with taking the study drug, and provide feedback on the well-being of the participant during each visit.
The caregiver can be a:
Family member
Daily companion
Legally authorized representative
Healthcare professional
We value your time.
The total duration of the clinical research study for participants, including screening, is about 20 weeks and includes 7 visits.
Each participant and caregiver will take part in a screening period of up to 4 weeks, followed by the treatment period of 12 weeks, and conclude with a follow up visit at week 16.
Brief Psychosocial Treatment (BPST)
During the screening period, participants and caregivers will be asked to take part in a BPST prior to receiving treatment in this clinical research study.
What is BPST?
BPST is a program that is used before someone with behavioral symptoms, such as agitation or aggression, enters into a clinical research study. The program involves the clinical research study participant and their caregiver spending 15 minutes a day together, taking part in a conversation and/or activity that they find enjoyable. The participant’s caregiver is trained and given a short treatment plan to follow each day. In addition, they will be supported by a therapist who will check in every few days to see how things are going.
Why is BPST needed?
BPST helps ensure participants entering the treatment phase of the study are going to benefit from the study drug. If someone shows an improvement in their behavioral symptoms after the BPST, then there might not be a need for the study drug. This is important as the study team does not want participants to take the study drug if they do not need to. BPST helps to provide the study team with confidence that an improvement seen in the clinical research study can be associated with the study drug.
What are the benefits of BPST?
BPST should be enjoyable for the participant and their caregiver. The program allows the participant and the caregiver to spend more time together and provides them both with tools to use every day.
Why Participate in this Clinical Research Study?
Clinical research studies look for new ways to prevent, detect, and/or treat disease. They are designed to test the safety and effectiveness of investigational drugs to understand if these potential treatments can be used in the future. Even if participants do not directly benefit from the results of the clinical research study, the information gathered can help others and add to scientific knowledge. People who take part in clinical research studies are vital to the process of improving medical care.
By participating in this clinical research study, you or your loved one may:
- Play an integral role in the advancement of agitation associated with dementia of the Alzheimer’s type research.
- Receive care from a local doctor as well as study-related therapies and assessments provided at no cost.
- Evaluate whether this potential treatment can improve you or a loved one’s quality of life.
Common Questions
What is a clinical research study?
A clinical research study is conducted to learn more about how the human body responds to a study drug. Participants play a very important role in advancing medicine for present and future generations. Even though you may not directly benefit from being in this clinical research study, any information learned may help others with agitation associated with dementia of the Alzheimer’s type in the future.
What is an investigational study drug?
An investigational study drug has not been approved by regulatory authorities for commercial marketing and sale, but is allowed to be administered to participants for research purposes.
Will compensation be provided to participants?
Study-related therapies and assessments will be provided at no cost. Participants will not be paid to take part in this clinical research study; however, study-related expenses such as travel, meals, hotel, and parking may be reimbursed.
What are my rights as a participant and what will happen if I decide not to participate?
Participation in this clinical research study is entirely voluntary. Participants can withdraw from the clinical research study at any time. Your decision whether or not to take part in the clinical research study will not affect your current or future care at the facility. Consult with your study doctor if you are thinking about stopping or decide to stop.
How can I learn more about the study drug, Masupirdine (SUVN-502), and this clinical research study?
You can find more information on Masupirdine (SUVN-502) and this clinical research study by visiting clinicaltrials.gov for residents in the United States or clinicaltrialsregister.eu for residents in Poland.
Clinical Research Study Locations
Enter your zip code, city, or state in the below “Your location” field to find your closest study site.
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