Clinical studies Control volunteer Digital health
Research studies conducted in
human volunteers to better understand
the nature of a disease or to evaluate
the effect of an intervention (e.g.,
medication, surgical procedure, exercise)
on that disease. There are two main types
of clinical studies: clinical trials and
observational studies. A person with no known significant
health problems who participates in
research to test a drug, device or other
intervention. These individuals also
can contribute to observational studies.
Control volunteers serve as comparisons
for patient groups when they are
matched on certain characteristics,
such as age and gender. In Parkinson’s
research, they can test new therapies for
safety, help researchers define “non-
Parkinson’s disease” measurements or
be a bar against which natural changes in
Parkinson’s are compared. A broad scope of health initiatives
that include mobile health (devices
to track measures such as physical
activity), health information technology,
wearables (body sensors to measure
movement, sleep, etc.), telemedicine and
online studies.
Clinical trials
Research studies conducted in
human volunteers that evaluate the effect
of an intervention (e.g., medication,
surgical procedure, exercise) on
symptoms or other features of a disease.
See also: interventional trial
Cohort
A group of individuals participating
in clinical research. Cohort studies may
follow a large group of people over time,
for example, to see who does and doesn’t
develop Parkinson’s and learn about
potential causes and risk factors.
Comorbidity
Two or more diseases, such as anxiety
and Parkinson’s disease, that occur in the
same person at the same time.
Computed Tomography (CT) scan
A Computed Tomography (CT)
scan, sometimes called CAT scan
(for Computed Axial Tomography),
uses x-rays to create two-dimensional
images of different regions of
the body.
Controlled trial
A type of study in which a new
medication or procedure is compared to a
standard, called the control. The control
may be a placebo (inactive substance)
or the standard of care, which is what
medical experts widely use and accept as
the proper one.
See also: placebo-controlled
DaTscan™
DaTscan is a specialized imaging
technique that uses small amounts
of a radioactive drug to evaluate the
dopamine-producing cells in the brain.
By itself, it can’t diagnose Parkinson’s,
but it can help confirm a doctor’s
diagnosis. DaTscan is being studied as a
possible biomarker of Parkinson’s.
See also: biomarker
De novo Parkinson’s
This describes Parkinson’s that was
recently diagnosed and often is not yet
treated with medication. (Some studies
do allow participants who are on certain
Parkinson’s medications, and each study
sets specific criteria.)
See also: telemedicine; virtual study;
wearable
Disease-modifying therapies
Treatments that can prevent, slow,
stop or reverse disease progression. No
therapy has yet been proven to modify
the course of Parkinson’s, but several
drugs with this potential are in various
stages of clinical testing.
Efficacy
A measure of a drug’s ability to treat
a certain condition; efficacy does not
reflect tolerability or ease of use. A
drug may be very efficacious but be
so unpleasant to take that its actual
use is very limited. Efficacy (as well as
tolerability and safety) is determined in
clinical trials.
See also: tolerability
Eligibility criteria
Guidelines for who can and cannot
participate in a specific clinical trial.
Criteria are comprised of certain
characteristics, such as age, gender, time
since diagnosis, stage of Parkinson’s
disease and other medical conditions.
Eligibility criteria include both inclusion
and exclusion criteria.
See also: exclusion criteria;
inclusion criteria
Glossary
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