The LIGHTWAVE Study is evaluating the safety and efficacy of an investigational oral drug in people with mild cognitive impairment or mild dementia due to Alzheimer’s disease.
About the LIGHTWAVE Study
The LIGHTWAVE Study is evaluating the safety and efficacy of an investigational oral drug in people with mild cognitive impairment or mild dementia due to Alzheimer’s disease. The clinical research study lasts up to 20 weeks, with up to 7 visits to the study site and 2 phone check-ins. Additionally, there will be assessments done between visits. The investigational oral drug is a capsule taken by mouth once a day.
Your eligibility to participate will be determined during the Screening Period.
During the first visit to the study site, among other things, you will:
Have been diagnosed with mild cognitive impairment or mild dementia due to Alzheimer’s disease (the study doctor can evaluate you if you have not been formally diagnosed)
Are able to walk*
Have a study partner willing to participate and assist with study activities and come to study visits, as needed
*Canes and walkers are permitted; wheelchairs are not.
The study doctor will discuss additional eligibility requirements with you or your caregiver.
Your safety is of the highest priority to us while participating. If you have questions or concerns at any point throughout the clinical research study, a study team member is available.
Your participation in the LIGHTWAVE Study is completely voluntary. If you decide to participate in this research study, you are always free to withdraw at any time, for any reason, without any penalty or effect on your medical care.
Talk to your doctor if you have any questions about Alzheimer’s disease or its symptoms.
If you qualify and decide to participate:
A study doctor will closely monitor you, your symptoms, and your overall health
All study-related procedures and the investigational oral drug will be provided at no cost
Travel assistance and reimbursement related to travel to and from the study site may be provided
Mild Cognitive Impairment (MCI) /Mild Dementia Due to Alzheimer’s Disease
Mild cognitive impairment and mild dementia generally occur in the early stages of Alzheimer’s disease. People may experience memory loss or loss of other cognitive ability but are still able to independently perform most everyday activities.1
Some may feel like they’re having memory lapses, and family and close friends may have noticed changes in behavior.2 A physician would be able to identify symptoms using questionnaires and other tools to diagnose this condition.2
Common challenges of mild cognitive impairment and mild dementia may include2:
Recalling the proper word or name
Forgetting something you just read
Remembering the names of people you’ve just met
Having difficulty performing certain tasks in work or social settings
Losing or misplacing something valuable
Experiencing increasing difficulty with organizing and planning
This section will address some questions that you may have.
Clinical research studies, also called clinical trials, are voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
An investigational drug is not approved for use or by prescription from doctors for the condition being studied. Investigational drugs are tested during clinical research studies to see if they are safe and effective for a specific medical condition and/or group of people.
Informed consent is the process of learning the key facts about a clinical research study before you decide to participate. It is also a continuing process throughout the clinical research study intended to provide information to participants.
To help you decide whether or not to participate, the doctors and nurses involved in the clinical research study will explain the details of the study. The study team will then provide you with an informed consent form to read.
The document includes details about the clinical 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 about the clinical research study, you will then decide whether or not to sign the document.
No study-related procedures can take place before you have signed the informed consent form. Your study partner will also need to sign an informed consent form. The informed consent form does not require you to continue your participation in the study, and you may withdraw from the clinical research study at any time.
The LIGHTWAVE Study is evaluating the safety and efficacy of an investigational oral drug on mild cognitive impairment or mild dementia due to Alzheimer’s disease.
Sage Therapeutics, Inc. is sponsoring the LIGHTWAVE Study.
To help ensure that a clinical research study is ethical and that participants’ rights are protected, Institutional Review Boards (IRBs), Ethics Committees (ECs), and the Food and Drug Administration (FDA) review study protocols and oversee clinical trials to ensure they adhere to federal law.
The LIGHTWAVE Study includes a Screening Period, a Baseline Period, a Study Treatment Period, and a Follow-up Period.
The purpose of the Screening Period is to determine whether you meet the requirements to take part in the clinical research study and obtain your consent to participate. You and your study partner will go through a set of interviews, answer questions about your health and symptoms, and have some assessments done. The study doctor will then review the results and determine your eligibility.
You and your partner will receive training on study procedures and devices at this time. You will also have your symptoms assessed before starting the investigational drug or placebo. There will be 1 study visit during this time.
Study Treatment Period
If you qualify, you will take either the assigned investigational drug or a placebo every day for 12 weeks. A placebo is an inactive treatment that looks similar to the investigational drug but does not contain the active medication. There will be 4 visits to the study site and 2 phone check-ins.
You will have a:
1 in 2 (50%) chance of receiving the active investigational drug
1 in 2 (50%) chance of receiving the placebo (which looks like the investigational drug but contains no active ingredients)
Neither you nor the study team will know which treatment you are receiving.
Additionally, there will be daily assessments you will do on a mobile phone. You and your study partner will complete various questionnaires and undergo tests to help the study doctor evaluate your health and symptoms. If you do not own a smartphone, one will be provided to you at no cost for the duration of the study.
After the Study Treatment Period, you and your study partner will come back to the study office for 1 follow-up visit 4 weeks after the Study Treatment Period ends.
All study-related procedures and the investigational oral drug will be provided at no cost. Transportation assistance may also be available, if needed. The study team can provide more information.
Yes, your participation in any clinical research study is completely voluntary. If you decide to participate in a clinical research study, you are always free to withdraw at any time, for any reason, without any effect on your medical care.
No, your doctor doesn’t have to give you permission to participate. Please feel free to talk to your doctor about participating in the clinical research study. With your permission, the study doctor will keep your regular doctor updated about your condition during the clinical research study.
You could experience side effects associated with the investigational drug or the placebo. There are also risks associated with some of the study procedures. Your symptoms may not improve or may get worse during the clinical research study. The doctor or study team will discuss all of the possible risks in detail with you.