Everything You Wanted to Know About Clinical Trials and Studies
Clinical trials are research studies that allow scientists to evaluate treatments while research studies can evaluate lifestyle interventions for Alzheimer’s and dementia. By participating, you can take part in developing new insights into the disease. These trials and studies come in different shapes and sizes. Understanding the type of research you’re participating in will help you understand its purpose and whether it is right for you.
Trials and studies are run by research centers or universities. They may also be sponsored by pharmaceutical companies testing out new drugs. Descriptors for the trial provide information about how far along a drug is in its development, or whether the trial involves a placebo — a sham version of the treatment to help scientists test its effects — is involved. (We’ll take a closer look at that below.) In general, there are three different categories of trials and studies. Here’s a quick run-down.
Types of trials and studies
Clinical trial: These studies are used to test whether a drug can treat or reverse the symptoms of Alzheimer’s disease. Currently, there are several Phase 3 clinical trials testing whether anti-amyloid drugs like lecanemab are “disease-modifying” — whether they can actually change the course of the disease, as opposed to just treating its symptoms.
Lifestyle intervention study: These studies test whether a lifestyle change — like a new exercise regimen or a change in diet — can improve the cognitive symptoms of Alzheimer’s or prevent symptoms from worsening. Some of these studies may be observational, meaning scientists analyze existing healthcare data to see whether people who ate healthier or exercised more were protected from Alzheimer’s.
Prevention study or trial: These studies determine whether a particular treatment can prevent the onset or the risk of developing Alzheimer’s or dementia. In one recent example, researchers administered the anti-amyloid drug crenezumab to a cohort of people with an early-onset form of the disease to see if it would impact disease progression and severity. (The trial did not succeed.) Often, these trials can last several years — especially in the case of testing early interventions, as years need to elapse before it’s clear whether the intervention was ultimately effective.
Glossary for clinical trials
Blinding: In a blinded trial, information may be withheld from participants and clinicians involved in the trial until the end. For example, participants in a blinded trial don’t know whether they’re receiving placebo or a treatment. In a double-blinded trial, neither the participants or the clinicians know whether the participant is receiving a placebo or a treatment.
Eligibility criteria: A list of requirements that volunteers must meet in order to participate.
Placebo: A sugar-pill that is given in lieu of a drug. Usually, people experience improvement because of psychological expectations, whether or not a treatment works. Comparing the improvement from a treatment compared to a placebo group provides scientists with a better idea of whether, or how well, it actually works.
Trial phase: There are three phases for clinical trials that are used for evaluating drug safety and efficacy.
- Phase 1, the earliest stage, is conducted in healthy volunteers to assess safety and dosing.
- Phase 2 looks to assess preliminary effectiveness and dosing in a larger group of patients.
- Phase 3 trials, sometimes combined with Phase 2 trials, test whether a drug works in a larger cohort of patients.
While not all the treatments or interventions tested in clinical trials or studies will succeed, when you participate, you’re playing an active — and very important — role in helping scientists answer pressing questions about what causes certain illnesses, and how to best diagnose, prevent or treat them.
Now that you know a little about trials, check out our ongoing trials on our website or call one of our two locations — Lady Lake in The Villages (352-441-2000) or Winter Park in Orlando (407-337-1000) — to learn more about Alzheimer’s, dementia, and cognitive health trials near you.
To learn about clinical trials of new medications that aim to modify the pathology of Alzheimer’s disease, call Charter Research at 407-337-1000 (Orlando) or 352-775-1000 (The Villages).