Working together to outsmart
HUNTINGTON’S DISEASE
Learn about a clinical research program investigating cognitive function in those with Huntington’s disease (HD) – with the potential to help advance the future of HD treatment.
About the PERSPECTIVE Program
The PERSPECTIVE Program is evaluating the safety and efficacy of an investigational oral drug in adults with early Huntington’s disease. The program is comprised of 3 clinical research studies. The investigational drug, SAGE-718, is believed to target cognitive symptoms. Investigational drugs are not approved by a health authority for any use, as the safety and efficacy have not yet been established.
You should discuss participation in the PERSPECTIVE Program with your doctor.
You may invite a partner to attend study visits and help you to complete program activities. While having a partner is not required for participation, it is recommended to give you additional support and insights about your condition.
Eligibility for each study within the PERSPECTIVE Program is determined at the screening visit. During the visit, you will:
- Meet with the study doctor and staff
- Review additional eligibility criteria
- Have an initial evaluation and assessments
- Complete the program questionnaires
How Do I Qualify?
To be eligible for the program you must:
- Be 25 to 65 years of age
- Have been genetically confirmed with Huntington’s disease
- Be ambulatory (able to walk)
These are not all the eligibility criteria; please discuss the eligibility criteria with your doctor.
You may invite a study partner to attend visits and help you to complete program activities. A study partner is optional to participate in the program.
The study doctor will discuss additional eligibility requirements.
Your participation in the PERSPECTIVE Program is completely voluntary. If you decide to participate, you are free to withdraw at any time, for any reason, without any penalty or effect on your medical care.
If you qualify and decide to participate:
- A study doctor will closely monitor you, your symptoms, and your overall health
- All program-related procedures and the investigational oral drug will be provided at no cost
- Transportation assistance may be available, if needed. Please talk to the study team for more information
About Huntington’s Disease
Huntington’s disease is a progressive brain condition that is passed down in families.1,2 It causes uncontrolled movement, decline of mental (cognitive) abilities, and behavioral changes.2
- Huntington’s disease (HD) is caused by a genetic mutation2
- Symptoms typically appear between the ages of 30 and 50, but can occur earlier or later1, 3
- If a parent has HD, there is a 50/50 chance that their child will inherit it1
Cognitive symptoms may include:1,3
- Difficulty paying attention
- Trouble thinking through steps of an activity
- Difficulty thinking through complex problems
- Difficulty planning, remembering, and staying on task
- Impaired judgment
- Difficulty with multitasking
As Huntington’s disease progresses, it will become more and more difficult to continue performing daily activities. Although there is no cure for HD, there are ways to help manage some of the physical and behavioral symptoms.1 Currently, there are no approved treatments to manage the cognitive symptoms associated with HD. The investigational drug in this study is being evaluated for possible effects on cognitive symptoms due to HD. Talk to your doctor if you have any questions about Huntington’s disease or its symptoms.
References
- Overview of Huntington’s Disease. Huntington’s Disease Society of America. Accessed February 23, 2023. https://hdsa.org/what-is-hd/overview-of-huntingtons-disease/
- Huntington Disease. Medline Plus/US National Library of Medicine. Updated August 18, 2020. Accessed February 23, 2023. https://medlineplus.gov/genetics/condition/huntington-disease/
- Cognitive Symptoms. Huntington’s Disease Society of America. Accessed February 23, 2023. https://hdsa.org/what-is-hd/cognitive-symptoms/
Frequently Asked Questions
This section will help answer some important questions you may have.
The studies within the PERSPECTIVE Program all include a Screening Period and a Study Treatment Period.
Screening Period: The purpose of this period is to determine whether you meet the requirements to take part in one of the studies. You, and an optional study partner, will go through a set of interviews, answer questions about your health and symptoms, and have some assessments done at the study office. The study doctor will then review the results and determine your eligibility.
Study Treatment Period: If you qualify for the study and decide to enroll, you will take either the investigational oral drug or a placebo. A placebo is an inactive treatment that looks similar to the investigational drug but does not contain the active medication. You will also be asked to come into the study office to complete various questionnaires and undergo tests to help the study doctor evaluate your health and symptoms.
After completing the Study Treatment Period, you can talk to your study doctor about next steps.
No, all program-related procedures and the investigational oral drug will be provided at no cost. Transportation assistance may also be available, if needed.
Yes, your participation in any clinical research program is completely voluntary. If you decide to participate in the study for which you qualify, you are always free to withdraw at any time, for any reason, without any effect on your future medical care.
No, your doctor doesn’t need to give you permission to participate, but feel free to talk to your doctor about participating in the clinical research program. With your permission, the study doctor will keep your regular doctor updated about your condition during the program.
Yes, the information you provide will not be shared with anyone who is not directly associated with the PERSPECTIVE Program without your permission (except as required by law) or as outlined in the informed consent process. Please see the privacy policy for additional details.
A clinical research program is a group of two or more clinical research studies evaluating the same condition or investigational drug.
A clinical research study, also called a research study or clinical trial, evaluates the safety and efficacy of an investigational drug to find out how it compares to a placebo (which looks like an investigational drug but contains no active ingredients). It is only through the completion of research studies that the investigational drug can be evaluated and, if proven safe and effective, approved for use for the condition that was studied. Research studies are performed according to government regulations that help protect the safety and rights of the participants.
An investigational oral drug is not approved for use or prescription by doctors for the condition being studied. Investigational oral drugs are tested during research studies to see if they are safe and effective for a specific medical condition or group of people, or both.
You could experience side effects associated with the investigational oral drug. There are also risks associated with some of the program procedures. Your symptoms may not improve or may get worse during the clinical trial program. The program doctor or staff will discuss all of the possible risks in detail with you.
Informed consent is the process of learning the key facts about a research study or program before you decide to participate. It is also a continuing process to provide information to participants. To help you decide whether or not to participate, the doctors and nurses involved will explain the details of the research study. The team will then provide you with an informed consent form to read. The document includes details about the research study, such as its purpose, duration, and required procedures. Risks and potential benefits are also explained in the informed consent form. After you have received and read the information, you will then decide whether or not to sign the document. No research study or program-related procedures can take place before you have signed the informed consent form. The informed consent form does not require you to continue your participation in the study, and you may withdraw from the research study at any time.
The PERSPECTIVE Program is evaluating the safety and efficacy of an investigational oral drug in adults with early Huntington’s disease.
The PERSPECTIVE Program is sponsored by Sage Therapeutics, Inc.
To help ensure that a clinical research program is ethical, and that participants’ rights are protected, Institutional Review Boards (IRBs) or Ethics Committees (ECs) review program protocols.