Frequently Asked Questions – TRAILBLAZER-ALZ 2

Frequently Asked Questions

About this Research Study

The TRAILBLAZER-ALZ 2 Study is looking for participants to evaluate an investigational drug for those who have experienced memory loss due to early symptomatic Alzheimer’s disease. In order to meet study eligibility criteria the participant must:

  • Be 60 to 85 years old

  • Have memory loss that has gotten worse over time

  • Have a study partner who knows you and is willing to attend appointments with you throughout the study
    *The study partner must be able to speak about the participant’s day to day routines and any changes with the research staff throughout the study

There are additional criteria that are reviewed by the study team at the study center at the first appointment. 

The study coordinator can answer any more questions you may have about the TRAILBLAZER-ALZ 2 Study. For more information about memory loss, we encourage you to speak with your doctor.

The TRAILBLAZER-ALZ 2 Study involves taking the study medication (investigational drug or placebo) every 4 weeks intravenously (IV).  Participants will need to visit the study center for each infusion. The study may also include appointments at an imaging facility at a separate location. The treatment period will last about 17 months.

This initial appointment is an opportunity for you to:

  • Learn more about the TRAILBLAZER-ALZ 2 Clinical Research Study. You’ll be speaking with a study coordinator at the study center to learn more regarding your participation in this study.

  • Ask any important questions you may have. These can be any questions you may have about this study or clinical research in general.

  • Determine if the TRAILBLAZER-ALZ 2 Clinical Research Study may be right for you. After speaking with the study coordinator and learning details about this study, the research staff will perform a series of screening tests to determine if you pre-qualify to participate. If you pre-qualify, you will be given an opportunity to decide if participation is right for you. If you agree to take part, the center will ask you to review and sign a consent form.

If you qualify, participation can last up to 2 years and 7 months, with up to 26 appointments with the study center. The study may also include appointments at an imaging facility at a separate location.  The study coordinator can answer any questions you have about the TRAILBLAZER-ALZ 2 Study.

If you qualify, you may visit the study center up to 26 times. The study may also include appointments at an imaging facility at a separate location.

The investigational drug being studied in the TRAILBLAZER-ALZ 2 Study will be delivered intravenously every 4 weeks.

A placebo is a substance with no active drug.  In this case, the placebo looks like the investigational drug but does not contain the active ingredient.   

Do not discontinue any medication unless you are advised to do so by the study center staff or your primary care physician.

The study centers are located throughout North America.

There is no cost to you or your insurance provider for participating in this study.  If you qualify for this study, study-related care will be provided at no cost to you. 

No, health insurance is not required in order to participate.

Research studies are designed in specific ways to test the investigational drug for safety and effectiveness. One or more of the answers that you provided were outside of the eligibility criteria for this trial. This does not mean you will not qualify for different research studies.

About Research Studies

A research study (also known as a clinical trial) is a medical study that is designed to answer questions about the safety of potential new drugs and to find out how well they work. These studies must be performed before a potential new medication or treatment can be approved for use in patients and sold to the general public.  

 

It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments. 

 

For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Participants will be selected based on the eligibility criteria and the number of participants needed by the researchers.

Research studies are used to test medications before they are sold to the general public. The testing that takes place during the studies provides information regarding the safety and effectiveness of the potential medication.

One way to find information about clinical trials is by searching this website: www.clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research. ClinicalTrials.gov is updated regularly and offers information on each trial's purpose, who is qualified to participate, locations, and phone numbers to call for more information.

For those who are qualified, taking part in research studies offers several benefits:

  • Getting actively involved in their own health care
  • Having access to potentially new research treatments 
  • Having access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied
  • Helping others by contributing to medical research

It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments. 

For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers.

Research studies can be sponsored by an organization such as a pharmaceutical company, a federal agency such as the Veterans Administration, or an individual, such as a physician or health care provider. The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, doctor's offices, and/or at hospitals.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the study. Participants must sign an "informed consent" form before joining the study, indicating they understand that the study is research, and that they can leave the research study at any time. This informed consent helps ensure that a prospective research study participant understands what’s involved.

About early symptomatic Alzheimer’s disease or early Alzheimer’s

Early symptomatic Alzheimer’s disease causes a slight but noticeable and measurable decline in cognitive abilities. It involves problems with memory, thinking, language, and judgment skills. If you have early symptomatic Alzheimer’s disease, you may be noticing changes in your memory. You may feel like your mental functions are “slipping”, but the changes have not become severe enough to significantly interrupt your daily life.

Some early signs of Alzheimer’s disease include memory loss that disrupts life, challenges in planning or problem solving, difficulty completing familiar tasks, confusion with time or place, difficulty with words in speaking or writing, poor judgement and more. 

Source: https://www.alz.org/alzheimers-dementia/10_signs

When it comes to questions about your health, you’ve always sought out the answers. Why stop now?

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