Essay on New Drug for the Treatment of Lewy Body Dementia

The establishment of a new drug, which translates to a new cure to particular condition/disease, requires a lot of intensive research. The FDA call for clinical trials to be conducted on how a new medication would work on the intended subjects. Specifically, factors such as the effectiveness, efficacy, and safety of the drug in the elimination of the condition are crucial. In the case of Lewy Body Dementia, a variety of consecutive trials are done on different patients.

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The entry criterion for the patients is based on the health of the individuals as well as their willingness to volunteer for the project. After the investigational product is conducted, maintenance studies follow so that the sponsor companies are able to establish the sufficiency of the trial design. Exclusion from the trials of the disease include individuals who have disorders that are unsuitable which include; cardiovascular, respiratory, thyroid, gastrointestinal or hematologic. Additionally the presence of psychiatric disorder and substance abuse is a ground for exclusion of the participants in the trials.

Short and Long-Term Trials

The clinical trials for the establishment of new drug for the treatment of Lewy Body Dementia follow a given protocol, which contains a specific action plan. However, the major challenge that faces this trial is the fact that no knowledge exists on the causative agent of Lewy Body Dementia. As such, the short and long-term clinical trials focus on the treatment of the symptoms of the disease so that eventually the suffering would be alleviated. The main drug trials that are conducted on this disease include nelotanserin which focuses on dealing with the visual hallucinogens of the patients, rapid eyemovememts, as well as the sleep diosorders.

The determination of Lewy Body Dementia is based on DSM-5, which is the basis for diagnosis. These trials start with the administration of a single tablet of drug nelotanserin on every single day. To measure its efficacy, an examination is made on the ability of the drugs o affect the 5-HT2A receptor found in the brain. On the research studies that have bed conducted on 5-HT2A receptor, it has been established that they are responsible for the incidences of visual hallucinogens and neuropsychiatric disturbances. As such, to establish whether the drug is successful or not, the observational changes that occur to the patient after the drug is administered are analyzed. The determination of the safety and efficacy follows where a laboratory assessment is piloted and a report is made on the significant changes that are noted in the patient. More importantly, any adverse effects that are observable are made in the report.

The other trial that has been made on drugs used in the treatment of Lewy Body Dementia is that of Aricept. This medication, which treats mild dementia, is undergoing a fourth clinical trial. However, there is no data about the drug that has been reported. However, the drug is currently proved to be helpful in the improvement of the brain nerve cell functioning. Specifically, nerve cells operate in the presence of the acetylcholine. In other trials that have been made on the drug, it has been established that it can lead to improved cognitive as well as neuropsychiatric symptoms arising from Lewy body dementia. Additionally, increased concentration of the drug, which includes 5-10mg, saw the patients improve with regard to the mini-mental state exams with an impressive score of 2-3.8 points. Another key effect of this drug is that there were significant improvements in the behaviors of those patients.

Apart from the above-mentioned drugs, the treatment of Lewy body dementia and more specifically, the Alzheimer has also seen the trials of E2020. Following the approvals that were made on the drug in 1990s, it was found to be successful. Specifically, the study was done on 108 patients who had been diagnosed with Lewy body dementia.in the first phases, an observation of the patients was made on the effects that the administration of E2020 had on the patient over a period of 52 weeks. However, this period could be extended to 36 weeks. After a periodic increase in the concentration of the drug, the mini-metal state of the patients was determined through a careful examination of their cognitive functions. As is a norm in the trials, the safety was also evaluated through the study of any existing adverse events. The results of these trials indicated that donepezil effectiveness increased with an increased concentration of E2020. Compared to the placebo that was administered for similar periods and with similar concentrations, E2020 2was found to be more effective. The following table displays the results of clinical trials done on drugs for the treatment of Lewy body dementia.

Name of Drug Stage of Trial Recruitment criteria Dosage Period of Study Outcome of Trial

NelotanserinPhase 2 Adults of 50-85

Positive for DLB

History with Parkinsons disease

Mini-mental state examination score of 18 Single tablet 40mg,80mg 28days (no data)

Aricept Phase 4 Adults of 55-99 years

Positive for DLB

CRD score of 0.5

Mini-mental state examination score of 10 and 26.

12 weeks No data

E2020 Phase 3 Adults 50 years and above

Positive for DLB

CDR 0.5

Mini mental state examination score of 10 to 26

5mg and 10mg 52 weeks More efficient in treating symptoms of DLB than the drug-placebo.

RVT-101 Phase 2 Adults of 50-85 years

Probable DLB

Mini-mental state examination score of 14-26. 35mg and 70mg 24 weeks No data

Labelling Considerations

Development of Indication Statement

Most of the labelling of the drugs that have been clinically tried and approved by the FDA are obtained from the previous US approvals. Additionally, the EMA guidance document has specific manner in which the drugs are labeled.

Treatment of Lewy Body Disease

The development of an indication for both the EU and US requires the demonstration of the effects of Lewy body dementia before the efficacy of the specific domains such as behavioral changes and cognitive symptoms can be specifically claimed. When a claim is made, it should be supported with robust evidence. This evidence is that of clinical trials made with the aim of testing the specific aspects of efficiency, which is the basis of the claims being made. More importantly, the patient population that was studied as well as the element that was used as the comparator is critical. Indeed, it must be shown the importance of the rating scales that were used to show the validity and relevance of the drug.

Indication-Specific Contraindications, Warnings and Precautions

Black Box Warning

The announcement made by FDA in 2005 that all typical and atypical drugs must add black box warnings apply in the case of Lewy body dementia drugs. This warning should stipulate, Increased mortality in elderly patients with dementia-related psychosis, and therefore seek to warn the users of the risk of death that is associated with the use of the off-label drugs in the treatment of the old people having a dementia condition. The requirement of the use of black box warnings was based on a variety of epidemiological studies that shows a high risk of death in the elderly patients who are treated with the conventional drugs.

Warnings & Precautions/Adverse Effects

`Apart from the black box warnings, both the US and EU require that some of the sections are dedicated to the labeling of the known side effects of the drugs. These adverse effects should be closely monitored so that the regulatory bodies can approve them.

Applicability of Regulatory Vehicles for Program Acceleration/Designation

The concepts of differentiation and label optimization would arise from the investigational drugs indication as well as the quality of the data that is use to back the claim of efficacy by the sponsors.

Applicability of Regulatory Vehicles for Program Acceleration/Designation

An expedited regulatory process would be granted on investigational compounds that represent therapeutic areas that have several unmet clinical needs and where there is little treatment in the areas. One the core domains that have would lead to an expedited regulatory process is that of treatment of the negative symptoms that are associated with Lewy body dementia as well as well as those for the treatment of the condition. This would aid in providing a solution to the unmet clinical need.