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The TRAILBLAZER-ALZ 2 Clinical Research Study is evaluating whether an investigational drug works and how safe it is in people with early symptomatic Alzheimer’s disease. The study involves people who have memory loss that has gotten worse over the last six months or more. If you are noticing changes in your memory or ability to think clearly, you may pre-qualify.
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Frequently Asked Questions
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Who can participate in the TRAILBLAZER-ALZ 2 Clinical 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 the participant and is willing to attend appointments with them throughout the study. The study partner must be able to tell the research staff about the participant’s day to day routine and any changes in this throughout the study
Additional criteria will be reviewed by our study team at the first appointment.
The study team can answer any more questions the potential participant or study partner may have about the TRAILBLAZER-ALZ 2 Study.
What’s involved with study participation?
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 will also include appointments at one or more imaging facilities at separate locations. The treatment period will last about 17 months.
What can I expect on my first visit to the study center?
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 and clinician 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 clinician to learn 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.
How long is this trial?
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.
How many appointments are there?
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.
What is the drug being tested?
The investigational drug being studied in the TRAILBLAZER-ALZ 2 Study will be delivered intravenously every 4 weeks.
What is a placebo?
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.
Will I have to discontinue any current medication?
Do not discontinue any medication unless you are advised to do so by the study center staff or your primary care physician.
Where is the study center located?
The study center is located at 521 Mt Auburn Street - Suites 107, 109, 203, 209 Watertown, MA 02472
Does participating in this trial cost me anything?
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.
Do I need health insurance to participate?
No, health insurance is not required in order to participate.
About Research Studies
What is a research study?
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.
Why are research studies important?
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.
Where can people find out about research studies?
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.
Why should I consider participating in a research study?
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.
Where are research studies conducted?
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 specialized clinical research centers, universities, medical centers, clinics, doctor's offices, and/or at hospitals.
What is “informed consent”?
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
What is early symptomatic Alzheimer’s disease
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.
What are early signs of Alzheimer’s Disease?
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.