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New Early Alzheimer's Research Study

Frequent forgetfulness and difficulty with routine tasks may be more than just aging.

It's important to identify symptoms early.

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New Aim. New Target.

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.

About 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.

Symptoms may include:

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.

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The majority of people turning 65 years old will spend their retirement years caring for someone with Alzheimer’s or living with it themselves.1

About the Aware Study

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. This study will help determine if the investigational medication is safe and effective at slowing the progression of Early Alzheimer’s disease.

The study will last about two years and four months. During this time, the study participant will receive either the investigational medication or a placebo through monthly intravenous (IV) infusions. If pre-qualified and referred to a study office, the study team will provide additional information.

This research study involves both people with Early Alzheimer's disease and a study partner. The study partner is someone who knows the participant well and can come to some study visits and answer questions about the participant’s symptoms.

Why is a Study Partner Needed?

Some of the things the Aware Study is evaluating are changes in 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.

How to Qualify

Participants do not need to be previously diagnosed with Early Alzheimer's disease to pre-qualify.

Qualified participants must:

  • Be 55-85 years old
  • Meet the clinical criteria for mild cognitive impairment or probable Alzheimer’s disease
  • Have a study partner who is willing to participate in the study and attend some study visits

If pre-qualified, participants will visit a study doctor who will complete a full evaluation to determine study eligibility.

Why Participate?

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.

Qualified participants:

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Alzheimer’s disease affects over 40 million people throughout the world.2

Map locations Study Site Map

Study Locations

The Aware Study is a global study conducted at approximately 65 study sites across several countries:

Frequently Asked Questions

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About Clinical Trials

What is a clinical trial or research study?

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.

Who oversees 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.

Who can participate in a research study?

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.

What is an investigational medication?

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.

About Alzheimer’s Disease and This Study

What is Alzheimer’s disease?

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:

  • Trouble retaining new information
  • Frequently losing a wallet or keys
  • Forgetting appointments
  • Neglecting to pay bills
  • Difficulty paying attention

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:

  • Trouble doing routine tasks
  • Changes in mood and personality

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.

Why is this study being conducted?

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 65 research sites worldwide.

Who is the study sponsor?

AbbVie is the sponsor of the study. To learn more about the sponsor, visit https://www.abbvie.com.

How long is this study?

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.

What kinds of tests and procedures are involved?

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 participating 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 explains in writing the study’s purpose, procedures, benefits and risks of the study and will be fully reviewed with the participant prior to making the decision to participate.

What to expect when participating in the Aware Study?

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, receive 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.

What is the role of the study partner?

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.

Study Medications and Other Medications

What is the investigational study medication?

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.

What is a placebo? What is the chance of receiving a placebo?

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.

Does the participant need to stop taking their current Alzheimer's medications?

If the participant is using medication to treat symptoms related to Alzheimer’s disease, the participant may continue to use those medications.

Privacy, Stopping Participation, Costs and Permission

What happens to personal information?

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.

Can participation in the study stop at any time?

Yes, participation 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.

Does the participant have to pay to participate in the study?

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.

Will the participant be paid for taking part in the study or reimbursed for travel?

Reimbursement for travel expenses may be provided. If pre-qualified the study team can provide more information.

Will the participant’s doctor have to give permission to participate?

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 permission, may contact the personal doctor to discuss the participant’s participation and progress throughout the study.

Sources:

  1. http://www.alz.org/boomers
  2. http://www.alzheimers.net/resources/alzheimers-statistics/