Welcome to our patient glossary! Some of the words we use might be new to you, so we’ve broken down our most frequented terms and phrases.
Amyloid PET Imaging / Positron Emission Tomography:
This is a type of scan that shows our doctors how your tissues and organs are functioning. This scan produces 3D images and shows us the presence of Beta Amyloid, a type of protein in the brain related to Alzheimer’s.
A lumbar puncture is a collection of cerebrospinal fluid taken from a needle, after being inserted into your two lumbar bones at the bottom of your spine. A lumbar puncture gives our doctors an indication of Alzheimer’s related brain proteins, such as Beta Amyloid or Tau. Watch this video
by the Alzheimer’s Society to learn more about the process of a lumbar puncture.
Along with Tau, this is one of the proteins that researchers have identified as contributing to the onset of Mild Cognitive Impairment and Alzheimer’s disease.
This is when one or more parties involved in the trial does not know which drug, the placebo or the real drug, has been assigned to which patient. It helps prevent conscious or unconscious bias throughout the trial.
In a double-blind trial, only the study pharmacist knows what medication the patient has been assigned. The participants, nurses, doctors and other clinical staff are unaware.
European Medicines Agency – This is an EU agency that oversees the use of medicinal products.
Cognitive assessments are used to measure things such as memory, language, reasoning and perception. If you are enrolled on one of our Alzheimer’s trials, we may complete one of these assessments with you.
Mini Mental State Examination (MMSE)
An MMSE exam is a type of cognitive assessment. It is used a lot in research and helps diagnose dementia and its severity. It will test a patient’s memory, attention and language through a series of questions, but there are no right or wrong answers and it is not something you can pass or fail – it exists only as an indication of your current cognitive function.
These types of tests will assess how well a patients’ nervous system is functioning.
Clinical Dementia Rating
The clinical dementia rating system will scale a persons dementia by assessing cognition and function.
The purpose of Informed consent is to protect the participant and is used by researchers to explain the clinical trial to potential volunteers. The research team will review all details of the trial with the potential participant and will answer any questions. The information will be in a clear and easy to understand consent form which the patient will sign to show their understanding of the trial and what their participation means – this does not mean that they cannot withdraw from the trial – all patients have this right. You can withdraw from a trial at any stage, for any reason.
Institutional Review Board (IRB)
This is a group of researchers, doctors, scientists, advocates and members of the community who have been formally assigned to review and monitor all research being conducted involving humans. IRB’s are in place to provide an impartial oversight and to protect study participants.
This type of study investigates health outcomes amongst groups of people in the course of their everyday life. Usually, researchers are observing the effect of a risk factor, diagnostic test or treatment without trying to influence or change who is or is not exposed to it by introducing a placebo. You can read more on the different types of studies and what they mean here.
Columbia Suicide Severity Rating
This is an assessment used to determine a person’s risk of suicide.
“Open Label” / “Non-placebo” extension
Open label/non placebo extensions are commonly given to patients after the end of a phase III clinical trial. When the study has finished, people on the trial are invited to continue their medication in what is known as an open label or non-placebo extension, in which participants are given the study drug usually until the drug is licensed. The objective of this sort of extension is to gain an understanding of the long term safety and tolerability of the drug. This is one of the primary benefits of being on one of our studies, as the medication is given to everyone whether or not they were on the placebo drug.
In most clinical studies, the investigational drug is pitted against a placebo which is known as a sham drug, or “dummy pill”. To pass the phases of the studies, the real drug needs to be statistically more effective than the placebo.
This is done so that researchers are able to discover the true pharmacological effect of the real drug, and so that the placebo effect is accounted for. The patient will not be told until the unblinding process which drug they were given.