Clinical Trials and Studies
What is a Clinical Trial?
As part of clinical research, researchers may conduct a clinical trial (also known as medical research, clinical study or drug trial) to answer questions about the safety and effectiveness of new medical interventions, including ways to screen, diagnose, treat, or prevent disease. Other examples of clinical research include: long-term studies that involve psychological tests or brain scans; genetic studies that involve blood tests but no changes in medication; and studies of family history that involve talking to family members to learn about people’s medical needs and history. .
Every clinical trial follows a pre-defined protocol that includes: clear criteria for eligibility; detailed information about the purpose of the study; who is conducting it and the exact procedures; and risks and potential benefits. Researchers will present essential information about the study to patients considering participation and should provide time to answer any questions. This information will also be presented in writing for participants to review and sign as part of an informed consent process for joining the study.
Click here for information about phases of clinical trials.
What to Expect
Not everyone who is interested in participating in a specific clinical trial will be eligible. Each study protocol has strict inclusion and exclusion criteria to ensure that the results can be interpreted clearly. If a person is eligible, the research team will explain the study in detail including potential risks and benefits and what the volunteer must do if he or she becomes involved. After careful consideration, the interested volunteer will sign the informed consent and be enrolled.
Members of the research team will evaluate the participant’s health at the start of the trial and give the person specific instructions about participating. The participant will be monitored carefully during the study according to the protocol, and typically will have some continued contact with the research team after the trial is finished. Usually, there is no cost to the participant for study-related services; travel expenses may be covered as well but it is important to ask if any travel expenses are covered and up to what maximum dollar amount.
How to Participate
If you are interested in participating in clinical trials or clinical studies, make sure you understand what is involved in volunteering for clinical research as well as the details of the specific study for which they are eligible.
There are various ways to learn about what clinical research is being conducted in frontotemporal degeneration.
ClinicalTrials.gov – maintained by the U.S. National Institutes of Health (NIH) of federally and privately funded clinical research, the registry provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions. A search feature lets you look specifically for studies in FTD. Enter “frontotemporal degeneration”, “frontotemporal dementia”, or search terms for the specific FTD disorders: primary progressive aphasia, progressive supranuclear palsy, cortical basal degeneration, or ALS and FTD to view a full list of all registered trials, eligibility criteria, participating medical centers and contact information for each.
NIH Clinical Center – conducts research in a wide range of diseases, including frontotemporal dementia. The Clinical Center’s website is designed to help people learn more about clinical trials, why they matter and how to participate. In addition, health care professionals can read about evidence-based strategies for talking with patients about trials, and find audience-tested posters to help promote trials in clinics and offices.
ARTFL Network – a consortium of academic medical centers partnered with patient support organizations conducts clinical research in sporadic and familial FTD. ARTFL is funded by the National Institutes of Health and is part of the Rare Diseases Clinical Research Network.
LEFFTDS – conducts longitudinal studies of people in families who have inherited a pathogenic mutation in progranulin, C9ORF72, or tau. A primary goal of LEFFTDS is to identify the most robust and reliable methods to track disease progression in familial FTD so that disease-modifying therapeutic trials can be designed appropriately.
Currently Recruiting Clinical Trials and Studies
For the convenience of our FTD community, AFTD maintains a listing of Currently Recruiting Clinical Trials and Studies, updated quarterly.
December 2016 Update — Behavioral Variant FTD Research Study: A new study by ICON Clinical Research is seeking persons diagnosed and their care partner to participate in an interview or focus group to gather information about their experiences with bvFTD.
Webinar Training on FTD Clinical Trials
Recorded: May 13, 2013
Susan L-J Dickinson, CGC, MS
Jill Shapira, Ph.D., RN
Training was provided to FTD support group facilitators for continuing education. The goal of this session is to educate and empower people with FTD and their families as they face increasing opportunities to participate in research that will lead to the first approved drugs for FTD. Click to access the archived webinar, the handout and slides from the presentation.