Study: Results from Phases II/III of Clinical Trial of Gantenerumab, a Treatment for Alzheimer’s Disease

Roche has recently released the results of the latest phases of their study of gantenerumab, which is a treatment of a rare form of Alzheimer’s disease. This form, which is inherited in an autosomal dominant pattern, comprises less than 1% of the cases of this disease. While gantenerumab did not meet its primary endpoint, researchers are still hopeful for other arms of this study and its contributions to knowledge of the condition.

About Alzheimer’s Disease

Alzheimer’s disease is a progressive disorder that causes the degeneration and death of brain cells. It does occur in stages, with severity increasing as time goes on. In the later stages of the disease, people will experience significant memory loss and be unable to carry out everyday tasks.

The major symptom of this condition is memory loss. Other issues that people experience include problems with thinking and reasoning, making judgments and decisions, planning and completing familiar tasks, and preserved skills. They will experience changes in personality and behavior. Other complications can also arise from Alzheimer’s, such as aspiration, pneumonia, infections, falls, fractures, bedsores, malnutrition, and dehydration.

Medical professionals believe that Alzheimer’s is caused by a combination of genetic, environmental, and lifestyle factors. In the case of the form of Alzheimer’s being studied by Roche, it is caused by genetic factors that are inherited in an autosomal dominant pattern. What healthcare professionals do know is that brain cells deteriorate and die. They also suspect that plaques and tangles, which are both proteins, play an important role.

There are risk factors that may heighten the chances of developing Alzheimer’s disease. Age is a major factor, as people usually develop this condition after 65. If one has a relative that is affected, they are also at a higher risk. Females are also affected at a higher rate than males. Those with past head trauma, poor sleeping patterns, poor exercise patterns, and have other unhealthy lifestyle habits are have a higher chance of Alzheimer’s disease.

Doctors will typically diagnose Alzheimer’s disease after a finding of characteristic symptoms. Tests will be used to confirm a diagnosis, such as a physical and neurological exam and brain imaging, like MRIs and CT scans. After it is confirmed that one has Alzheimer’s, treatment typically consists of cholinesterase inhibitors and memamtine.

About Gantenerumab

Gantenerumab is an investigational medication that is meant to bind with aggregated forms of beta-amyloid and remove plaques. It is believed that these plaques lead to the cell death in the brain. It is currently being evaluated in two studies, GRADUATE 1 and 2. The DIAN-TU-001 study was recently completed.

Results of the DIAN-TU-001 Studies and Ongoing GRADUATE Studies

Phase II of the DIAN-TU-001 study was recently completed, and it did not meet its primary endpoint. The Washington University School of Medicine conducted this study with the purpose of slowing cognitive decline. While the endpoint was not met, it was concluded that the safety profile is consistent with previous trials. They did not find any new problems in safety in this trial.

Although gantenerumab did not reach the endpoints it was meant to in the DIAN-TU-001 study, that is not affecting medical professionals’ hope for the GRADUATE studies. The difference between these studies is that DIAN-TU-001 was evaluating the effects in those with autosomal dominant Alzheimer’s, while GRADUATE studies are investigating sporadic Alzheimer’s. GRADUATE studies are meant to expose patients to the highest possible dosage of gantenerumab.

Researchers are confident in the remaining studies and hope that this medication will be able to better the lives of those with Alzheimer’s disease.

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