Frequent forgetfulness and difficulty with routine tasks may be more than just aging.
The Aware Study is evaluating an investigational medication that targets a protein called tau, which builds-up in the brains of people with Early Alzheimer's disease.
Early Alzheimer’s disease causes problems with memory, thinking and behavior. Although the exact cause of the disease is not known, scientists are now researching investigational medications that target different abnormal proteins in the brain and other features of Early Alzheimer's disease. Researchers have found that two proteins called tau and amyloid build-up in the brains of people with the disease even before they have any symptoms.
At first, symptoms may be mild, and over time may occur more frequently or get worse, eventually interfering with daily activities.
Sometimes, a loved one notices these symptoms first. Although difficult to accept, identifying symptoms early lets you take advantage of available treatments, support and research studies.
16.1 Million Americans provide unpaid care for people with Alzheimer’s or other dementias.1
Some of the things the Aware study is evaluating are changes with memory, thinking, mood and behavior. Sometimes a loved one may notice these changes earlier and will be able to describe symptoms to the study team.
Each study participant needs a study partner. The study partner should know the participant well and have frequent contact with him or her. They will be required to attend some study visits to answer questions about the participant's symptoms.
If pre-qualified for the study and referred to see a study doctor, participants will be provided with the full study partner requirements.
Participants do not need to be previously diagnosed with Early Alzheimer's disease to pre-qualify.
If pre-qualified, participants will visit a study doctor who will complete a full evaluation to determine study eligibility.
Whether you want to explore treatments, learn more about Alzheimer’s disease, or help researchers learn more, participating in a research study is a personal decision.
Alzheimer’s disease affects over 40 million people throughout the world.2
The Aware Study is a global study conducted at approximately 80 study sites across several countries:
A clinical trial, also referred to as a research study, is a scientific study that evaluates the safety and efficacy of an investigational medication. A research study may show that the investigational medication is better than, as good as, or worse than the standard treatment or inactive placebo. Qualified doctors, nurses and other medical professionals will conduct the study.
It is only through the completion of research studies that investigational medication can be evaluated, and if proven safe and effective, approved for general use by appropriate regulatory or health authorities, such as the U.S. Food and Drug Administration (FDA). Prescription medications in use today were first proven safe and effective in research studies.
To help ensure that a research study is ethical and that participants’ rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve study protocols.
All of the people who participate in research studies are volunteers. For each study, only volunteers who meet all of the eligibility criteria may participate. To qualify for the Aware Study, the study team at the selected study office will review the participant’s medical history and current health against eligibility criteria. The study team may also ask questions and run some tests to determine if the participant qualifies.
An investigational medication is a medication that has not been approved by appropriate regulatory or health authorities, such as the U.S. Food and Drug Administration (FDA) for prescription use. Investigational medications have yet to be proven safe and effective.
Alzheimer's is a disease of the brain and is the most common cause of dementia. It causes problems with memory, thinking and behavior. Symptoms of Early Alzheimer’s disease may include:
These symptoms may be mild at first and classified as “mild cognitive impairment.” Over time, they may occur more frequently or get worse, eventually interfering with daily activities. More severe symptoms may include:
Even if you’re reluctant, it’s a good idea to see a doctor to get diagnosed early. If doctors determine it’s Early Alzheimer’s disease, you may be able to benefit from available treatments or you may be able to participate in a research study. Your doctor may also be able to discuss life-style changes that may help you.
The purpose of the Aware Study is to evaluate an investigational medication being tested for Early Alzheimer’s disease.
The study will evaluate the safety and efficacy of the investigational medication to see if it may slow the progression of Alzheimer’s disease. Approximately 400 people will participate in this study, which will be conducted at about 80 research sites worldwide.
AbbVie is the sponsor of the study. To learn more about the sponsor - visit https://www.abbvie.com.
The study lasts up to 2 years and 4 months. The participant will need to make approximately 30 visits to the study office during that time.
If the participant pre-qualifies and is referred to the study office, the study team will provide additional information to the participant and study partner at that time.
The staff at the study office will discuss the medical aspects of the Aware Study with the participant and study partner. The participant and study partner will be able to ask questions and decide if joining the study is the right choice. If the participant qualifies and decides to participate, the study team will provide the participant with a document called an Informed Consent Form. This form contains a written explanation of the study's purpose, procedures, benefits and risks and will be fully reviewed with the participant prior to making the decision to participate.
Study eligibility is determined by performing assessments and procedures discussed during the Informed Consent review. If study criteria are met, the participant will continue in the study. The participant will periodically come to the study office to receive medication, exams and to evaluate general health and symptoms. It is important to attend all scheduled visits.
The participant may discuss any study related medical care with the study doctor or other study staff at any time during the research study.
Those closest to the participant may notice changes in the participant’s behavior before they do and can tell the study team about them. He or she will go with the study participant to some study visits and answer questions about the participant’s symptoms. Tracking symptom changes accurately is an important part of this study. The study partner will also be required to sign an Informed Consent Form.
ABBV-8E12 is a new type of investigational medication that targets tau protein in the brain. It is being evaluated in this study to determine if it may slow the progression of Early Alzheimer’s disease. This investigational medication is administered by intravenous (IV) infusion every 4 weeks during the study.
ABBV-8E12 has not been approved by the Food and Drug Administration, and it is not known if it is safe or effective.
A placebo looks like the investigational medication but does not have any investigational medication in it. It is used in clinical trials to see if the investigational medication being evaluated is more effective than no treatment at all, and also helps to assess the safety of the investigational medication. The participant will be assigned to receive either the investigational medication or placebo at random.
Participants have a 3 in 4 (75%) chance of receiving the investigational medication and a 1 in 4 (25%) chance of receiving placebo. Neither the participant nor the study doctor will know which the participant is receiving.
If the participant is using medication to treat symptoms related to Alzheimer’s disease, the participant may continue to use those medications.
The study team respects and protects the participant’s privacy. The study team will not share the participant’s information except as required by law. The study team will store the participant’s personal information with codes that do not identify the participant. The Informed Consent Form has more information about the participant’s privacy.
Yes, your involvement in the study is voluntary. The participant may stop participating at any time. If the participant decides to stop early, please notify the study team. The study team will ask the participant to return to the study office at least once for follow up tests to check the participant's health once the investigational medication has been stopped.
No. The participant will receive all study-related care, including the investigational medication, at no charge. The participant does not need insurance to participate in this study and the participant’s insurance company will not be notified.
Reimbursement for travel expenses may be provided. If pre-qualified, the study team can provide more information.
No. The participant’s doctor does not have to give his or her permission to take part in the study. However, either the participant or the study doctor, with the participant’s involvement, may contact the personal doctor to discuss the participant’s involvement and progress throughout the study.