Clinical Trials in Alzheimer Dementia in Boston MA and south shore,

Clinical Trials

A clinical study is research using human volunteers (also called participants or subjects) that is intended to add to medical knowledge by investigating disease progression or effects of intervention on the disease. There are two main types of clinical studies: observational studies where no specific treatments or interventions are provided and clinical trials (also called interventional or treatment studies). Alzheimer disease center conducts both interventional and observational studies.

In a clinical trial, participants receive specific interventions according to a pre-specified research plan or protocol created by the investigators and approved by monitoring agencies. These interventions may be drugs or medical products such as devices, procedures, or even changes to participants’ behavior, such as diet or exercise. Clinical trials may compare a new medical approach to a placebo that contains no active ingredients, to a pre-existing standard care that is already available, or to no intervention. They can also compare existing interventions to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful or no different than available alternatives (including no intervention). The investigators also try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have dementia to see whether their brain protein decreases or cognitive performance improves.

Clinical trials used in drug development are sometimes described by the phase. These phases are defined by the Food and Drug Administration (FDA). Typically Phase 1 occurs after extensive animal research and typically looks at the safety of subjects. Phase 2 and 3 occur after human subjects have already received the candidate intervention in Phase 1 and look for efficacy and help quantify side effects.

Observational Studies

In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol. Participants may receive interventions (which can include medical products such as drugs or devices) or procedures as part of their routine medical care, but participants are not assigned to specific interventions by the investigator (as in a clinical trial). For example, investigators may observe a group of older adults to learn more about the effects of different lifestyles on cardiac health.