What is a clinical research study?
Clinical research studies are designed to test the safety and effectiveness of an investigational drug before it is submitted for approval by a government healthcare agency (U.S. Food and Drug Administration, Health Canada, Ministries of Health, etc.) for general use by the public. All clinical studies are conducted under the direction of healthcare professionals. Researchers must comply with guidelines and safeguards to protect study participants. In addition, an Institutional Review Board (IRB) or Independent Ethics Committee must review every study before it starts. An IRB is an independent committee that is typically made up of physicians, statisticians, community advocates, and others to help ensure that a study is ethical and that the rights of the patient are protected.
Who is conducting this clinical research study?
The TANGO Study is being conducted by qualified and well-trained clinical research study doctors and medical specialists in locations around the world.
Who is the sponsoring company?
The sponsor for this clinical research study is Biogen, a leading pharmaceutical company that develops therapies for people living with serious neurological, autoimmune, and rare diseases.
What are the symptoms of mild cognitive impairment / mild Alzheimer’s disease?
What is the investigational drug?
The investigational drug, called (BIIB092), is designed to target the tau protein, which is one of the key proteins that build up in the brain of Alzheimer’s patients. Researchers are evaluating the investigational drug to see if it may help reduce the spread of tau in the brain—potentially slowing the progress of the disease.
Would participation in this clinical research study cost me anything?
If you qualify for this clinical research study, all of the study-related visits, tests, assessments, and the investigational drug or placebo that you receive as part of your participation are provided at no cost to you.
Would I be paid for participating in this clinical research study?
Some study centers may provide payment or reimbursement for travel or parking expenses. The amount varies by location. If you prequalify for this clinical research study, the clinical study staff at the study center will discuss this with you in further detail.
Is travel assistance available?
Yes, travel assistance for you and your study partner to and from study visits may be available. The study staff can provide you with more information about this if you are eligible to participate.
Where are the clinical research study locations?
There are a number of clinical research study locations across the country. If you prequalify for the study, a list of site locations will be available for you to choose the most convenient location.
Would I have to stop taking my current medications?
It depends on the medication(s) you are currently taking. If you prequalify for this clinical research study, the clinical study coordinator will discuss this with you in further detail and address any of your questions and concerns.
Is there a placebo?
Yes, one-in-three study participants will be randomly assigned (by chance) to receive placebo.
What is a placebo?
A placebo is an inactive substance designed to resemble the investigational drug and is administered in the same way. Placebos are commonly used in clinical research studies to help researchers determine the effects of the investigational drug.
How often would I have to go to the study site?
What should I expect when I go for the first visit?
At your first visit to the study center (if you prequalify based on your answers to this screening survey), you will meet members of the study team who will explain the potential risks and benefits of this clinical research study and ask you to review the Informed Consent Document. This document will provide you with a detailed description of the clinical research study. If you decided to participate, your signature on the Informed Consent Document will confirm your understanding of the potential risks and benefits of the study, as well as your willingness to participate. Participation is entirely voluntary, and you may stop participating in the study at any time.
When will I know if I qualify for this clinical research study?
The questions we are asking are used only as a preliminary screening. If you prequalify based on your answers to the screener, a member of the clinical research study staff will contact you and schedule a Screening Visit to determine if you fully qualify for this clinical research study.
Does my family doctor, primary care physician, or specialist have to give his or her permission for me to participate in this clinical research study?
No. Your family doctor, primary care physician, or specialist does not have to give his or her permission for you to participate in this clinical research study. However, we encourage you to let your doctor know that you plan to participate in this clinical research study. He or she can contact the clinical research study doctor with any questions about the study.
What should I tell my family doctor, internist, primary care physician, or specialist?
We encourage you to tell your doctor that you are considering becoming a participant in a clinical research study evaluating an investigational drug for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease.
What are the potential risks for participating in this study?
There may be other side effects, including some that are not yet known.
I am worried about confidentiality. Who will have access to my name and the information you are collecting?
Any information you provide will not be shared with anyone who is not directly associated with this clinical research study.
Is the investigational drug approved by the Food and Drug Administration (FDA) or any other regulatory body around the world?
Most investigational drugs in clinical research studies are under investigation and are not approved to treat a particular disease or condition until all phases of the clinical trials are completed and the results are reviewed. This investigational drug has not been approved for application. This study is designed to help determine dosing and if it is safe and potentially effective in slowing disease progression. All clinical trials conducted must be reviewed by regulatory boards that review all materials and study procedures to guarantee that a trial is humane and ethical.
What is an investigational drug?
An investigational drug is a drug that is not approved to be on the market yet by the FDA or other regulatory bodies around the world, but may be tested in clinical research studies such as this one to determine its safety, potential effectiveness, and dosing.
Why do you need my postal code?
We need your postal code in order to determine if there is a participating clinical research study site in your area.
Why do you need my age?
You must be within a specific age group to participate in this clinical research study.
Why do you need my contact information?
If you prequalify for the clinical research study, your contact information will be provided to the study center near you. The center will use this information to contact you to schedule a time for a thorough screening to determine if you fully qualify to participate in this clinical research study.
What phase is this clinical research study?
This is a Phase 2 clinical research study.
What is a Phase 2 clinical research study?
What is an Informed Consent Document?
This is a document that provides you with a detailed description of the clinical research study. Your signature on the informed consent form documents that you have been provided with information about the clinical research study, that you understand the potential risks and benefits of the clinical research study, and that you are willing to participate. Participation is entirely voluntary, and you may stop participating in the clinical research study at any time and for any reason.
Are there any side effects or drug interactions?
There may be other side effects, including some that are not yet known.