Breakthroughs in the medical field, especially in the coming up of a new drug and finding a cure to a disease, are achievable through research. Clinical trials provide an analysis of how a new medicine works on people, its efficacy, effectiveness, and safety in eradicating the disease. A comparison of treatments is made possible through conducting consecutive trials on different patients. Thus, this paper studies on clinical trials on Lewy Body Dementia. It specifically looks at the ongoing trials although, followed by recognizing the failures on some of the tried medicines and other relevant reviews.
Ongoing and Successful Trials
It is important to note that clinical trials are conducted by following a given protocol that describes the action plan. The performance of the trials is done on both the healthy individuals and the patients volunteering on the project. By using ClinicalTrials.gov as the resource site, there are various ongoing clinical trials in search of a solution to the Lewy Body Dementia currently. The challenging factor facing this research is that the causative agent of the disease remains unknown. These clinical trials on the disease focus on treating the symptoms that eventually relieve the patient from suffering. The performance of drug trials such as nelotanserin to deal with visual hallucinations, rapid eye movement, and sleep disorder in subjects with the disease is an ongoing clinical test, titled, Open-label Study of Nelotanserin in Lewy Body Dementia with Visual Hallucinations or REM sleep Behavior Disorder. The same case applies for the Study Evaluating Nelotanserin for Treatment of Visual Hallucinations in Subjects With Lewy Body Dementia. The success of this drug is determined through observation of changes occurring in the patient after the administration of the drug. In determining the safety and efficacy of the drug, the researcher is set to perform an evaluation of the laboratory assessment, make reports on significant changes in the patient, and monitor any adverse effects resulting from the use of the drug.
Similar to the drug trials on nelotanserin, the use of aricept to treat mild dementia is also undergoing clinical trials, under the title, A Post-Marketing Clinical Study of Aricept in Patients with Dementia with Lewy Bodies (DLB). As of now, the drug is known to improve the functioning of the brain nerve cell. The operation of these nerve cells usually works under the presence of the chemical acetylcholine. Patients suffering from dementia are found to have reduced levels of the chemical inhibiting the functioning of the brain nerve cells. Trials on the drug are being performed in quest of finding a solution to its effects, especially its effects in reducing mental alertness.
Alternatively, it imperative to recognize the effectiveness of the drug E2020 in treating Alzheimer is a success story following its approval in the mid-1990s following a Study of E2020 in Patients with Dementia with Lewy Bodies (DLB), Followed by a Long-term Extension Phase. The close association of Alzheimer to Lewy Body Dementia prompts the need to perform clinical trials of the drug in treating dementia. As a consequence of its success in treating dementia, modification of the drug to improve on its effectiveness is on the rise. It is because ongoing clinical trials on the drug are based on the different modified forms.
Failed Clinical Trials on Lewy Body Dementia
The failures in the clinical trials on dementia can be attributed to the fact that different neurodegenerative conditions cause the disease. The treatment of the illness is based on the symptoms, which are found to be pronounced later in life when the disease has already in advanced stages. More so, the heterogeneous nature of the disease further cripples the development of a cure.
Dating back to the year 2012, the drugs bapineuzumab and solanezumab failed during clinical trials. They were designed to target the protein beta-amyloid associated with the Alzheimer disease. The failure of the drugs was seen in their inability to improve on memory. On the other hand, some drugs thought to treat the disease have been found to have many profound effects on the patient such that they aggravate on the situation. Increased anxiety, swelling, mental instability, as well as nausea, are some of the effects found in drugs designed to treat Alzheimer, thereby questioning their use in treating dementia.
In the past, clinical trials were focused on the beta-amyloid and tau proteins. These proteins are associated with the formation of aggregates in the brain. Based on this information, drugs were designed to target these proteins; however, they failed in curbing the progression of the disease. Failure of the drugs to meet the safety standards tends to result in the termination of the drug use.
It is through the failures of the clinical trials that researchers can make improvements and come up with more effective drugs. An example is a case study on the performance of two drugs on dementia, termed as Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia with Lewy Bodies (4). The drugs under the comparison study were memantine and placebo. Clinical trials gave much higher positive results on the use of the drug memantine, especially when combined with acetylcholinesterase inhibitors. Patients under placebo were more prone to syncope.
The success of the drug galantamine in treating a mild case of dementia is downplayed by its side effects, which based on the period of drug use, can increase the mortality rate as indicated by the Study of Safety and Efficacy of Galantamine in Patients with Dementia with Lewy Bodies (3). This research shows that the drug exposes the user to the risk of artrio-ventricular blocking and the onset of bradycardia. A case study on the drug donepezil, titled, Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients with Dementia with Lewy Bodies (DLB) reveals the effects of the drug in glucose absorption. The patients complained about the loss of appetite, feeling fatigue, reduced activity, muscle cramps, and diarrhea.
On the other hand, based on a study on the changes in the sleeping habits of dementia patients, the use of nelotanserin is found to alter the normal sleep patterns inducing more sleep to the patient according to the study titled, Evaluating Nelotanserin for Treatment of REM sleep Behavior Disorder in Subjects with Dementia with Lewy Bodies
Review on the Clinical Trials
There is no doubt that repeated failures in finding the treatment of dementia are discouraging researchers. Apart from that, it is estimated that the numbers of dementia cases are on the rise as pointed out in A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients with Dementia with Lewy Bodies (DLB) (Study E2020-J081-431). Also, the clinical trials are usually expensive in regards to the ongoing Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients with Dementia with Lewy Bodies (DLB) and other related clinical studies. Hence, research institutions are encouraged to perform trials on earlier stages of the disease where there is a greater chance of managing it before it develops to the more threatening stages. World economies are currently allocating grants to researcher and making calls for more researchers to join the field.
In finding a solution to the problem, the public is advised to seek medication at the onset of symptoms. Health checkup may help reveal the probability of an individual contracting the disease, thereby enabling the establishment of an early diagnosis.
Despite the development of technology, there remains no cure for Lewy Body Dementia. Clinical trials are limited to understanding the symptoms and finding their treatment. However, there are notable advances with the hope of finding the cause and treatment of the disease. The nature of the illness is the ultimate challenge facing researcher. It is important to assess the safety, efficacy, and effectiveness of a drug before it is administered to the patient. This precaution is geared towards preventing any further deterioration of the patients health while searching for a cure.
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