Alzheimer's Disease Research

What happens before joining a trial?

• Before joining a clinical trial, potential participants and their care partners are given information about the study and have the chance to ask questions. This process is called informed consent. The purpose of the process is to make sure participants and their care partners understand important details about the clinical trial. This can help them to make an informed choice about participating. Informed consent begins before a person agrees to participate in a trial and continues throughout the study.

How do I know if I, or someone I know, can participate in a trial?

• Each clinical trial has a set of rules for who can participate, these are usually called ‘inclusion and exclusion criteria’. The rules may require a participant to:
  • have a certain level of disease (such as mild, moderate, or severe)
  • be within a particular age range
  • have a specific medical history

These rules help protect participants and help to answer the research questions. Potential participants go through a screening process to see if they fit the rules. If a person does not qualify for one study, another study could be a better fit.

How is participation in a clinical trial different to the typical standard of medical care?

• For Alzheimer’s clinical trials, participants will probably need to visit the study doctor more often than they would for normal care. These frequent visits may go on for a year or more. During the clinical trial, there are different types of assessments. These may include:
  • lab tests
  • physical exams
  • imaging studies such as MRI (magnetic resonance imaging)
  • thinking and memory tests

Thinking and memory will be monitored throughout the study to see whether any of the interventions have made a difference. The assessments can be different for each clinical trial, it’s important to follow the instructions provided by the study doctor.

After joining a trial, can a participant stop taking part?
Participants may stop taking part in a clinical trial at any time, for any reason. No matter the stage of the trial, participants have the right to change their mind and withdraw. If a participant decides to withdraw, the study doctor will remove them from the trial in a way that is safe for the participant.

What happens once a participant finishes the trial?
After the trial, a participant should work together with their primary doctor to figure out the best next steps and care plan. Care partners and loved ones can also play a key role at this point. The investigational medicine (the medicine that was studied) from the study may need to be looked at in more clinical trials. It may also be reviewed by regulatory agencies and approved for use outside of a clinical trial.

As a clinical trial participant, you would contribute to the long history of volunteers around the world. Together, trial participants help researchers answer important health questions and discover new medical treatments.

Does someone have to be with me for me to participate in an Alzheimer's clinical trial?

• Most Alzheimer’s clinical trials need participants to have a study partner. Study partners are a vital part of the dementia research process. Study partners are usually family members or friends who know the participant very well. They usually go with the participant to study visits. Study partners may be asked to:
  • help with informed consent
  • ensure study compliance
  • provide a perspective on the participants cognitive, functional, and behavioral symptoms.