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A Groundbreaking Study in Latin America

DNA strandLocated in the northern hills of the Latin American country of Columbia, the secluded towns in the state of Antioquia give scientists a unique opportunity to study disease. As a result of its long-term isolation from newcomers, the intermarriage of residents has allowed genetic mutations to persist through generations. 

Because the region’s gene pool has not experienced any significant genetic mingling, it is ideal for studying bipolar and cardiovascular disease, Alzheimer’s disease, and juvenile diabetes. Unlike general population studies requiring big data collection to tease out disease occurrence patterns, a relatively pure population investigation cuts to the chase.

In 2013, Genentech, a U.S. unit of Roche, the U.S. National Institutes of Health, and Banner Alzheimer’s Institute in Phoenix began funding a five-year study of a new Roche drug. The $100 million trial is testing the theory that an accumulation amyloid plaque in the brain is the most likely cause of Alzheimer’s disease. 

The study is testing several hundred people to determine if the Roche drug can block or retard the amyloid formation or the events that lead to it. Scientists consider the study a breakthrough trial and close-to-perfect test of the amyloid formation premise.

Furthermore, scientists supporting the amyloid theory believe that previous trials failed because they targeted patients whose advanced Alzheimer’s disease put them beyond help. In this study, researchers are beginning treatment before the onset of systems in a population who would likely get the disease without intervention.  If the anti-amyloid injections can block plaque buildup and symptoms, preventing Alzheimer’s disease looks more promising.

A Colombian neurologist, Dr. Francisco Lopera has spent the last 30 years studying the aggressive Alzheimer’s common to the region. In fact, Dr. Lopera and fellow researchers traveled on foot to remote towns or had people come in by horseback in order to compile a database of 4,300 natives genetically at risk for Alzheimer’s.

With Dr. Lopera’s extensive database, the ambitious trial became possible. The database contains people who carry the E280A Presenilin-1 gene mutation that causes early onset Alzheimer’s. The certainty that they will get the disease creates a perfect group for testing the effectiveness of the new crenezumab anti-amyloid drug in preventing it.

The greatest concentration of early onset Alzheimer’s representing less than 2% of cases globally is in the state of Antioquia in northern Colombia. In this groundbreaking study, 200 trial participants carrying the mutation get the injection while the remaining 100 non-carriers receive a placebo.  The study will conclude in 2020 when the last participant finishes treatment.

Interested or Involved in a CNS Trial?
Learn more about the intricacies of CNS clinical trials by attending ExL Events’ inaugural CNS Clinical Trial Forum, coming to Bethesda, MD November 2-3, 2015. This is the only event in the marketplace to focus on improving the quality of central nervous system trials, developing innovative partnering models, recruiting the ideal patient and gaining treatment approval.

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