A clinical research study for those with early symptomatic Alzheimer’s disease
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
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.
Approximately 15% to 20% of people age 65 or older have mild cognitive impairment (MCI), an indicator of early symptomatic Alzheimer’s disease.
Someone with early symptomatic Alzheimer’s disease is at an increased risk of developing Alzheimer’s Disease or another dementia.
The risk factors most strongly linked to Alzheimer’s Disease are advancing age, family history of Alzheimer’s or another dementia, and conditions that raise risk for cardiovascular disease.
The causes and treatment of Alzheimer’s Disease are not yet understood, but clinical research studies like TRAILBLAZER-ALZ 2 are committed to finding the answers.
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.
The main objective of a clinical research study is to answer questions about the safety and effectiveness of potential new medications. These studies must be completed before a new treatment can be offered to the public. Right now, there are over 300,000 clinical studies in progress all over the world.
For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. It is important to test medications and medical products in the people they are meant to help.
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:
*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:
If you qualify, participation can last up to 2 years and 7 months, with up to 26 appointments with the study centre. 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 centre up to 26 times. The study may also include appointments at an imaging facility at a separate location.
The investigational drug being studied is 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 centre staff or your primary care physician.
The study will be conducted at the NeuroCentrix research centre located in Melbourne (Noble Park).
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.
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.
For those who are qualified, taking part in research studies offers several benefits:
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.