Novartis Plans Alzheimer’s Study in Symptomless Patients

Novartis AG plans to test experimental drugs in a study to see whether the medicines can prevent Alzheimer’s in people without symptoms who are genetically predisposed to the disease.

In partnership with Banner Alzheimer’s Institute, a Phoenix, Arizona-based nonprofit, the Swiss drugmaker will test two drugs targeting the amyloid protein that builds up in the brains of people with Alzheimer’s. The trials will gauge the response of symptomless patients with two copies of the APoE4 gene that’s known to raise the risk for the disease.

The National Institutes of Health is partially funding the study with a $33.2 million grant awarded in 2013 as part of a U.S. initiative to test and treat the disease earlier. More than 5 million Americans have Alzheimer’s disease, the most common form of dementia, and the number is expected to triple by 2050, according to the Alzheimer’s Association.

The study, which aims to enroll 1,300 patients ages 60 to 75, will “accelerate the evaluation of treatment not only for the small group, but for the general population who are concerned about the risk,” said Eric Reiman, Banner’s executive director, in a telephone interview.

One therapy is an immunotherapy treatment injected to trigger antibodies to attack the amyloid proteins that play a role in the disease. The other therapy is an oral pill taken daily to prevent production of different forms of the protein.

Nine-Year Study

Since only about 2 percent of the worldwide population have 2 copies of the ApoE4 gene, the study could take over a year to recruit, said Michael Ryan, a vice president at Novartis Pharmaceuticals Corporation, a U.S. arm of the company. By screening for people without symptoms, it can facilitate treatment as early as possible, he said.

The Basel, Switzerland-based company projects that it could take nine years before the studies show results, Ryan said. The trials, planned in North America and Europe, still require government approval.

The association said ApoE4 gene is implicated in close to 25 percent of Alzheimer’s cases and is the risk gene with the greatest known impact. Having the gene, however, doesn’t mean that a person will develop the disease.

Banner studies show that almost 50 percent of people with one ApoE4 gene have Alzheimer’s disease, with the onset age at 75. For people with two copies of the gene, 91 percent have it with onset at age 68.

Delaying Progression

Delaying the progression of the disease by only five years can reduce the number of inflicted patients by half, Reiman said. The disease, for which there’s currently no cure, is one of the top leading causes of death in the U.S.

Funding for the study also include $15 million in contributions by the Banner Alzheimer’s Foundation. The efforts extend on Banner’s Alzheimer’s Prevention Initiative that began with a $100 million study on 300 people in Colombia that carry a more rare form of genetic mutations that affect early onset of the disease, triggering symptoms around age 45. This study is a collaboration with Roche Holding AG’s Genentech division and the University of Antioquia in Colombia.

To recruit for the study, the groups will have to perform genetic tests on potential candidates to see if they two copies of APoE4. This practice has been controversial because patients found with copies of the gene had no treatments for the disease if they were found to be predisposed.

“This situation is now changing,” said Jessica Langbaum, a principal scientist at Banner. “We’ve taken very careful consideration in this.”

People that take the genetic tests will first learn about the study online, consent to it through electronic signature, then will be mailed a cheek swab for the genetic testing. They will then receive counseling at one of 60 study sites through an in-person visit.

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