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Trials to Test New Treatments for Inherited Alzheimer’s

Nerve cells illustration

(commonfund.nih.gov)

25 April 2016. Clinical trials are planned to assess experimental treatments and new diagnostics for inherited forms of Alzheimer’s disease. The new studies, which extend earlier trials of drugs to treat inherited Alzheimer’s disease, are funded by a $4.3 million grant from Alzheimer’s Association in Chicago.

Like the earlier trials, the new round of studies will evaluate treatments for dominantly inherited Alzheimer’s disease that results from a genetic mutation. People with this type of Alzheimer’s disease tend to develop symptoms, such as loss of memory or cognitive abilities, earlier — during their 30s, 40s, or 50s — than sporadic, age-related Alzheimer’s disease that often forms after age 65. While people with dominantly inherited Alzheimer’s disease make up about 1 percent of all people with the disorder, the earlier and predictable age of onset makes it possible to test drugs before symptoms appear.

The trials are expected as well to help develop treatments for age-related Alzheimer’s disease. Because the progression of Alzheimer’s in people with the mutation is similar to individuals with age-related Alzheimer’s, treatments shown effective in slowing or preventing degeneration of cognitive functions in people with the mutation may also work with individuals having the sporadic, age-related type of the disorder.

A consortium of pharmaceutical companies and Washington University in St. Louis in 2012 began clinical trials to test drug candidates with people found having dominantly inherited Alzheimer’s disease. The trials, known as Dominantly Inherited Alzheimer’s Network Trials Unit or DIAN-TU, assess the engineered antibodies solanezumab and gantenerumab, made by Eli Lilly and Company and Roche respectively, to slow the progression or prevent symptoms from occurring. The studies, still underway, recruited 210 participants at 26 sites.

The new set of trials, named DIAN-TU Next Generation, plan to test experimental treatments designed to prevent the accumulation of amyloid brain plaques, deposits of amyloid-beta protein fragments that build up between nerve cells in the brain and are often found in people with Alzheimer’s disease. In addition, the trials will evaluate new diagnostics for Alzheimer’s that aim to detect the disorder earlier in its formation:

– Positron emission tomograph or PET imaging that spots tangles of tau, abnormal collections of twisted and misfolded protein threads. The tau tangles attract large deposits of phosphate molecules that disrupt the healthy functioning of nerve cells, and damage the ability of nerve cells to communicate with each other.

– Increased home-based cognitive testing to detect subtle changes in symptoms of Alzheimer’s disease earlier on. If these tests are shown to predict the onset of Alzheimer’s they could be used as part of a treatment program with drugs to slow or prevent the development of symptoms.

The DIAN-TU Next Generation trials will recruit people with the characteristic gene mutation for dominantly inherited Alzheimer’s disease, but with mild or no symptoms. Participants will be randomly assigned to receive the test drug or a placebo for four years. Study teams will evaluate participants with cognitive tests given before, during, and after the trials, as well as with PET imaging scans and tests for characteristic biomarkers of Alzheimer’s disease. The researchers plan to expand the number of sites beyond the current 26 locations in North America, Europe, and Australia, to others in Europe, South America, and Asia.

Much of the funding for the trial is donated to Alzheimer’s Association by the investment firm Edward Jones. “The single greatest threat to financial security late into life,” says Jim Weddle, Managing Partner at Edward Jones in an Alzheimer’s Association statement, “is contracting a long-lasting disease that destroys a person’s savings and leaves them dependent upon their children or Medicaid. The most expensive of those chronic diseases, in both financial and emotional costs, is Alzheimer’s.”

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