New drugs for Alzheimer's have achieved satisfactory results

The search for a remedy for Alzheimer's disease (memory impairment syndrome) after a long time has reached a promising and potential milestone on July 25.

According to The New York Times, for the first time in a large clinical trial, researchers have developed a drug that can reduce plaque in the patient's brain while slowing the progression of the test. lost memory.

However, we need to do more tests to know if the new drug is really effective. But if the results were presented on July 25 at the Chicago Alzheimer's International Conference, it could be the first drug to effectively affect changes in the brain and symptoms. of Alzheimer's disease.

Drugs that treat Alzheimer's disease have made significant progress after a period of research.

Dr. Reisa Sperling, director of the Alzheimer's Center for Research and Treatment at Brigham Hospital and Women, Boston said: "This test shows that we have the ability to remove plaque and change cognition. I'm not. I know if we have created a miracle. But I feel that achieving this result is very encouraging because it is a sign of success. "

In addition to a few drugs that can slow memory decline in a few months, there is no effective way to treat Alzheimer's disease of about 44 million people worldwide, including 5.5 million Americans. It is estimated that these numbers will triple by 2050.

The trial was conducted with 856 patients from the United States, Europe and Japan with early symptoms of cognitive decline. Dr Lynn Kramer, medical director of Japanese pharmaceutical company Eisai, said patients were diagnosed with mild cognitive impairment or mild Alzheimer's dementia and that their brains all had amyloid deposits. . Eisai has developed a drug called BAN2401 with the cooperation of Biogen Company in Cambridge, Massachusetts, USA.

Of the 161 patients taking the highest dose, 81% showed that they significantly reduced amyloid plaque levels. Results showed that they "switched from amyloid plaque to negative" means that the patient's amyloid plaque level decreased from the correlation with dementia to below that threshold.

And through a series of cognitive and functional tests to measure memory and skills such as planning and reasoning, the group using high doses reduced memory by 30% compared to the rate of decline in the group. placebo.

Dr. Sperling said that amyloid plaque degradation is very special, but also that cognitive results are less important. However, she said: "If it can really slow memory loss by up to 30% for normal people or people with mild memory impairments, it is clinically important."

Dr. Samuel Gandy, deputy director of Mount Sinai's Alzheimer's Research Center, said that if the drug is really effective, it will allow patients to operate independently longer without others helping them perform activities. basic daily. The actual results are not saved in the data presented on July 25.

He said: "I will not assume that this is a sudden improvement. Because it is a convincing change process. But it is not clear whether those changes are enough to make a difference in everyone's life ".

Dr. Kramer said the results were reported 18 months after the patient started taking the medication, but after about 6 months showed improvements. And 253 patients in the second high-dose group also had amyloid plaque reduction results and improved similar perception.

Amyloid plaque degradation is very special, but it also indicates that cognitive results are less important.

However, in December 2017, companies reported that according to a statistical analysis of the 12-month trial predicted that the drug would not delay the expected memory loss. That means the test does not meet the standards, which has led some experts and investors to be skeptical about the effectiveness of the drug. The results after 18 months calmed that skepticism, although the Alzheimer's Association prudently declared it and said the results "weren't convincing enough to prove cognitive efficacy."

The results of measuring the safety and efficacy of a drug from phase 2 of the trial are often considered an intermediate step for a larger and larger phase 3. Other drugs gave promising results in the second phase but later brought disappointment in the third stage.

In this trial, patients were randomly assigned to 6 groups, with 247 patients receiving placebo while the other 5 received different doses. The unusual aspect of experimentation has raised questions for some experts. The two companies Eisai and Biogen used a cognitive assessment protocol that they created. Called the Synthesis Point of Alzheimer's Disease (Adcoms) , it is based on factors from three other cognitive tests.

Dr. Kramer said Adcoms was developed to synthesize measures from those three trials that are accurate enough to measure changes in the early stages of dementia. Data presented on July 25 showed that patients had positive results on two of the three established trials.

Some potential treatments for Alzheimer's have led to serious side effects that can cause dangerous brain swelling or bleeding. Only less than 10% of patients using the new drug work as well. That means this new drug is relatively safe.

The mechanism of action is to attack fibrous amyloid strings before they begin to stick together to form plaques. The results of the test are evidence that early treatment for Alzheimer's is more likely to succeed because the brain starts to deteriorate for years or even decades before memory loss is complete. Some other drugs have failed because they have been tested in patients with early Alzheimer's disease, others are the opposite.

Even if the results of the study continue to be positive, making the drug popular for patients may take years. Dr. Kramer and Ivan Cheung, Eisai's chairman and chief executive officer, said that the company recently submitted a request to the Food and Drug Administration (FDA) to learn the steps needed to approved drug.

The scientist is studying and finding Aizheimer cure.

"It is still early to talk about it at this time, but our goal is to bring BAN2401 medicine to patients and families as soon as possible," Cheung said.

FDA often requires clinical trial data at stage 3 to demonstrate the safety and efficacy of the drug. However, according to a spokesperson, the agency has procedures to expedite the review of drugs.

Eisai is a manufacturer of Aricept, one of the few drugs that can help slow early memory decline, but only works for about 6 to 9 months. And Biogen is another manufacturer of Alzheimer's drugs, aducanumab, has shown positive results in a phase 1 trial in both amyloid plaque reduction and slowing of cognitive decline. Many people in the Alzheimer's field are predicting the results of two clinical trials of aducanumab, which are expected to report results by 2020.

Dr. Gandy said the BAN2401 result boosted the prospect of aducanumab because it showed that at least two compounds are capable of attacking both accumulated amyloid plaque and cognitive impairment. In early July, when companies announced they would soon present positive results from the BAN2401 experiment, both companies' stock prices increased by about 20%.