Alzheimer’s disease affects the cognitive function of an individual. This disease is common among senior individuals. Not only does this disease make it difficult for patients to remember names, past events and places but it also makes the individual’s body forget how to function properly. To battle the symptoms of Alzheimer’s disease as well as manage the condition, clinical research studies in Tampa, Florida have been conducted by clinical researchers and other professionals.
The US Food and Drug Administration is the agency regulating the use of medicines. Before such agency approves the reproduction, distribution and sale of the said medicines, they should go through various trials. This is also the case with treatments for Alzheimer’s disease.
Treatment Trials
Treatment trials for Alzheimer’s disease often come in two types. These typically are treatments that focus on:
- Reducing symptomsWith this trial, the research team will test the effectiveness of a new medicine in reducing the symptoms of Alzheimer’s disease. The team may change the strength or dosage of the medicine to check for effectiveness. Combining it with other drugs may also be done as part of the trial.
- Slowing down the conditionIn this trial, researchers will test new medicines designed to slow down the progression of Alzheimer’s disease.
The Phases
Earlier, you have learned that new medications will have to undergo and pass different phases of clinical studies in Florida for them to be approved by the US FDA. The following are the phases involved in this entire process.
- Phase 1In this phase, around 100 healthy volunteers are used as test subjects. Researchers will take a closer look at the side effects as well as the risks involved in taking the medication being tested. For the study to proceed to the next phase, the medicine must pass the requirements set by the US FDA.
- Phase 2More than 100 individuals who have Alzheimer’s disease may enroll or volunteer for the phase 2 of the trial. At this stage, researchers will determine to gather more information about how safe and effective the drug is. At the same time, they will also determine the right dosage for treatment to the best of their ability.
- Phase 3Up to more than 1000 volunteers in multiple testing sites will be studied. This aims to provide the US FDA a strong evidence of the effectiveness and safety of the drug being tested. This is also the last phase as to whether the FDA will approve the drug or not.
- Phase 4Phase 4 is mostly post-marketing studies. Researchers will still monitor how the volunteers are doing relating to their intake of the drug.
Avita Clinical Research conducts medical studies in Florida to help find a cure for certain diseases. If you wish to volunteer, you may contact us online.
