Donanemab: What’s the new Alzheimer’s drug?

Donanemab, a new drug for Alzheimer disease has shown positive results in the clinical trial according to the study published in the New England Journal of Medicine.

What is Donanemab?

The renowned US pharmaceutical company Eli Lilly developed Donanemab as an antibody therapy to target the accumulation of abnormal amyloid-beta protein clusters in the brain, which is a hallmark of Alzheimer’s disease. The treatment involves intravenous infusion administered once every four weeks. To ensure patient safety, regular brain scans are necessary to monitor potential side effects, such as brain swelling and bleeding caused by the drug’s action.

More about the research

In the clinical trial, 257 participants diagnosed with early-stage Alzheimer’s were enrolled.
The researchers randomly divided these participants into two groups: one received donanemab, and the other received a placebo.
Administration was done via intravenous infusion every four weeks, and the trial spanned a total of 76 weeks.
The researchers evaluated the participants’ cognitive and functional abilities utilizing the Integrated Alzheimer’s Disease Rating Scale (IADRS), which utilizes a scoring system ranging from 0 to 144.
Additionally, they utilized emission tomography (PET) scans to measure changes in amyloid-beta levels within the participants’ brains.

Effectiveness of the drug

According to the study, Donanemab is not a cure. Patients of Alzheimer did not improve but they deteriorated more slowly than a control group that received a placebo.
Proving that drugs can alter the course of the disease, after decades of failed trials and billions of dollars invested in research, is regarded as a significant triumph.
On an average, the drug slowed the progression of the disease by 20-30% amounting to about 4-7 months over the course of 18-month trial.

Treatment of Alzheimer’s Disease

There is currently no known cure for Alzheimer’s disease.
The treatment covers multiple areas, including:
- Assisting individuals in preserving brain health.
- Managing behavioral symptoms.
- Slowing down or postponing the onset of disease symptoms.
Doctors recommend a healthy diet, regular exercise, adequate sleep, and risk reduction for diabetes and heart disease.
Particularly for the elderly and those with a family history, doctors advise maintaining mental engagement and activity.
This can involve solving puzzles, acquiring new languages or skills, and socializing by making new friends.

Risk with Donanemab

Donanemab Drug Trial Side-Effects: Donanemab exhibited significant side-effects during the drug trial.
Brain Swelling and Bleeding: Approximately 25% of patients receiving the treatment encountered brain swelling or bleeding, a notably higher rate in contrast to the control group, where only 2% experienced such issues.
Serious Problems: Importantly, it’s essential to highlight that severe problems were rare.
Loss of Lives: Tragically, four individuals lost their lives during the trial. Among them, three belonged to the donanemab group, and one was from the control group.

Two new drugs that got approval from US FDA

Notable drugs in recent weeks include aducanumab (marketed as Aduhelm) and Lecanemab (marketed as Leqembi), with the latter being the second monoclonal antibody to gain regulatory approval after Aducanemab.
Both drugs have demonstrated a substantial reduction in amyloid levels within the brain.
However, it remains less clear whether this amyloid reduction translates into a significant improvement in memory and cognitive function.
Lecanemab, in particular, has exhibited a 27 per cent slower decline in memory and cognitive abilities.

Significance

Donanemab, in a phase III trial, has demonstrated the ability to decelerate cognitive decline by 35% when compared to a placebo.
Remarkably, this marks the second drug within a one-year timeframe that has shown effectiveness in slowing cognitive decline among individuals with Alzheimer’s disease.
It’s crucial to understand that these two drugs do not halt or reverse Alzheimer’s disease.

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