New Alzheimer’s Criteria Replace Memory Tests, But Benefits Unclear 

United States: As another expensive drug for Alzheimer’s disease moves closer to an approval decision and as contemplated by the nonprofit Alzheimer’s Association, the final version of the current staging criteria for the disease has been released. 

More about the news 

But for the first time, the criteria proposes that doctors diagnosing the disease rely on biomarkers, pieces of beta-amyloid and tau proteins identified through lab tests or brain scans, as opposed to written tests checking on a patient’s memory and reasoning ability. 

The rationale for the change, according to the authors, is to detect the condition in its asymptomatic and most curable stages. 

However, it also implies that one may be told he or she has Alzheimer’s on the basis of blood tests alone, even when the individual is not facing any memory problems, CNN Health reported. 

What more are the experts stating? 

It is suggested that biology should be the basis of the diagnosis, rather than symptoms. Moreover, according to them, even if a person has no symptoms of a disease at a given time he or she may be affected by the same in future. 

However, the criteria have been termed as flawed by outside experts and drug industry watchdog groups who argue that one may have beta amyloid proteins in their brains as well as in their blood and also not show any signs of dementia. 

They also argue that there exist no scientific publications to back the notion that administering a patient with costly, high-risk administered drugs at the earliest indicators of disease will be of any benefit to the patient in the long run. 

Benefits of new treatments 

In clinical trials, the new drugs, which are antibodies on the pieces of the beta-amyloid that attach to it to be cleared from the brain, had showcased modest improvements, as CNN Health reported. 

Beta-amyloid peptides are proteins that are formed due to pieces of protein forming sticky plaques inside the brain. Altogether with another protein, tau, which forms fibrous tangles and inhibits the contact between nerve cells, they are included in the characteristic features of Alzheimer’s disease. 

Debate about the role of beta-amyloid 

As for the beta-amyloid, there is some disagreement on the part of experts about how it is connected with the disease, stating that the plaques are a result of the disease, not a cause. 

Evidence for new Alzheimer’s treatments came from an 18-month study of individuals with early-stage Alzheimer’s in which the lecanemab antibody, which was approved by the US Food and Drug Administration (FDA) in 2023, reduced the rates of cognitive decline by 27 percent compared with a placebo. 

Earlier last year, the test drug donanemab prevented the disease from progressing, leading to a 35 percent slowdown as compared to a placebo. 

However, this month, the expert group involved in deliberation with the FDA over the latter’s drug approval decision advocated for the approval of donanemab for Alzheimer’s disease. 

Risks involved with the drugs 

As per the experts, the drugs are not devoid of certain risks involved. Few studies have gone through tests to check the workability of antibodies in patients, along with amyloid deposition in their brains. However, without any apparent symptoms of improvement, it has not reported a positive impact on patients. 

According to Dr. George Perry, a neurobiologist and editor of the Journal of Alzheimer’s Disease, “There’s no evidence for it,” as CNN Health reported. 

Additionally, critics do say that novel criteria might drastically increase the number of humans who would be eligible for taking new drugs and thereby could generate enormous profits for those manufacturing the drugs in the process. 

According to Dr. Adriane Fugh-Berman, director of PharmedOut, a program based at Georgetown University that tracks pharmaceutical marketing tactics, “The Alzheimer’s Association should lose all credibility by releasing guidelines labeling perfectly normal people as having Alzheimer’s disease,” CNN Health reported,