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What Are Clinical Trials?


Overview


Clinical trials are research studies conducted in people to determine whether treatments are safe and effective. Clinical trials are the best way for researchers to find new ways to detect, slow, treat and hopefully someday prevent Alzheimer's disease.

Types of clinical research include:

  • Treatment trials to test new treatments or new combinations of treatments
  • Diagnostic studies to find new tests or procedures for diagnosing a disease or condition
  • Prevention trials to investigate ways to prevent the onset of diseases
  • Screening studies to test methods to identify diseases or conditions at the earliest stages
  • Quality of life studies to look at different ways to improve quality of life for individuals who have a chronic illness, their caregivers and family members

What's the difference between a clinical trial and a clinical study?


Clinical trials are sometimes referred to as clinical studies. While clinical trials technically refer only to those clinical studies involving drugs and other therapies aimed at slowing or stopping a disease, the terms are often used interchangeably.

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Treatment trials


Perhaps the best known clinical studies are those that test new treatments. Before a new drug or treatment can be approved by the FDA, it has to go through three phases of clinical trials. Most of the time, a clinical trial is designed to compare a new therapy with the best-known existing therapy for the disease being studied. When there is no proven treatment to use as a comparison, researchers are likely to compare the new drug with a placebo, which is a sugar pill or other inactive substance that has no treatment value but is made to look like the new drug in development.

There are two types of Alzheimer's treatment trials:

  • Treatments aimed at reducing symptoms. During this type of trial, new drugs and variations of existing drugs that aim to reduce the symptoms of Alzheimer's disease are tested. Studies of existing drugs explore whether changing the dose, taking the medication on a different schedule (more or less often), or combining it with other medications might further reduce or delays symptoms.
  • Treatments aimed at slowing or stopping the disease. During this type of trial, new drugs designed to slow or stop Alzheimer's disease are tested. Some of the experimental drugs being tested in treatment trials represent entirely new ways of treating Alzheimer's.

Diagnostic studies


Many clinical studies focus on finding better ways to accurately diagnose Alzheimer's disease, particularly in the early stages. These studies will hopefully lead to a trusted and easy-to-apply method that enables physicians to diagnose persons at risk for Alzheimer's — even before symptoms appear — and begin treatment (once such Alzheimer's treatments exist) in time to prevent the development of dementia.

Diagnostic studies are vital to the advancement of Alzheimer's research because they identify which individuals to treat and provide doctors with a way to track whether a treatment is working.

Other types of research


Researchers are working to uncover as many aspects of Alzheimer's disease and related dementias as possible. Examples include:

  • Prevention trials, where researchers look for ways to stop Alzheimer's from developing, often times in groups of people identified as being at higher risk. This type of study looks at whether a certain medication, vitamin or lifestyle change (for example, healthy eating or exercise) might prevent Alzheimer's disease.
  • Screening studies, where researchers look for ways to detect Alzheimer's disease as early as possible. Being able to diagnosis Alzheimer's early on provides an opportunity for care planning and to receive as much benefit as possible from current treatments.
  • Quality of life studies, where researchers try to better understand and address the needs of people with Alzheimer's and their caregivers. The goal of such studies is to figure out what types of support, education or training solve some of the challenges faced by people with dementia and their caregivers.

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What progress has been made?


While current drug therapies only treat the symptoms of Alzheimer's disease, researchers have great hope that in the near future there will be treatments that can stop or slow Alzheimer's.

The more scientists know about Alzheimer-related changes in the brain, the greater the chance of finding a treatment that prevents or reverses these changes.

New developments in research include:

  • Imaging techniques that allow researchers to see brain changes that may indicate Alzheimer's.

    Advances in Brain Imaging (approx 13 min.)
  • Markers in blood and cerebrospinal fluid (fluid that flows within the brain and spinal cord) that may signal Alzheimer's changes in the brain.

    Quest for Biomarkers (approx 17 min.)
  • Advances in genetics research to help identify individuals at increased risk for developing Alzheimer's.

    The Role of Genetics in Alzheimer's (approx 14 min.)

Learn about other progress milestones.