Alzheimer’s Association Announces Clinical Trial Competition

Pauline Anderson

August 18, 2016

The Alzheimer’s Association has announced a new $7 million investment in clinical trials targeting brain inflammation — but with a twist.

Four cutting-edge studies will receive $1 million each over 2 years, but the remainder will go to the clinical trial that demonstrates the most promise for treating Alzheimer’s disease.

In a press release, the association called this new competition format "unique" and "goal-driven."

The new focus on neuroinflammation follows somewhat disappointing trial results so far for drug candidates targeting amyloid and tau.

The announcement was made in partnership with philanthropist Michaela "Mikey" Hoag. The Part the Cloud Challenge on Neuroinflammation is the vision of Hoag, of Atherton, California, who has a personal connection to Alzheimer’s.

"When my father passed away with Alzheimer’s, I decided to use my personal story to rally others in support of Alzheimer’s research," said Hoag in the press release. "When my mother started to show signs of the disease, I knew I had to kick these efforts into high gear."

The hope, she said, is that the competition for additional funding will "speed the rate of discovery and deliver a new and effective treatment or prevention strategy."

Hoag’s efforts in partnership with the Alzheimer’s Association have raised more than $17 million for Alzheimer’s research with the help of more than 300 donors.

Funding from Part the Cloud is focused on moving promising laboratory research into early-stage human clinical trials. It supports both academic and company-based research; 100% of the proceeds go directly to Alzheimer’s Association–supported research.

Neuroinflammation Role

Increasing evidence suggests that neuroinflammation plays an important role in brain changes associated with Alzheimer’s and other neurodegenerative diseases, said Maria Carrillo, PhD, Alzheimer’s Association chief science officer. "By further understanding the role and the timing of neuro-inflammation and immune responses, we will be able to further accelerate novel candidate Alzheimer’s therapies."

Three of the four selected studies are testing potential therapies developed for other conditions that are being repurposed for Alzheimer’s.

"A genuinely new Alzheimer’s drug has not been approved since 2003, and the currently approved Alzheimer’s medications are ineffective in stopping or slowing the course of the disease," said Dr Carrillo.

The project that demonstrates the most viable translation to advanced clinical trials will be eligible to receive an additional prize of up to $3 million to further the proposed therapy’s development.

The funded projects are as follows:

  • A phase 2 clinical trial of sargramostim (Leukine, sanofi-aventis), a drug approved for reducing and preventing infection in patients who have received chemotherapy, to determine whether it is safe and can help slow or prevent progression of Alzheimer’s. This trial is led by Huntington Potter, PhD, professor and director of Alzheimer’s disease research, Department of Neurology, Linda Crnic Institute for Down Syndrome, University of Colorado Anschutz Medical Campus, Aurora.

  • A phase 2 clinical trial to determine whether a cannabis-based liquid medication previously tested for alleviating cancer-related pain (Sativex, GWPharma) reduces brain inflammation and slows progression to Alzheimer’s disease in people with mild cognitive impairment. The trial is directed by Isidro Ferrer, MD, PhD, coordinator of the neuropathology group at CIBERNED (Network Center for Biomedical Research in Neurodegenerative Diseases), Institute of Health Carlos III, Barcelona, Spain.

  • A phase 2 study to test whether a drug shown to be safe in sickle cell disease and asthma (Senicapoc, Icagen) can reduce brain inflammation, alter the rate of brain amyloid accumulation, and improve memory in people with early Alzheimer’s disease or mild cognitive impairment, led by John Olichney, MD, professor and neurologist at the University of California, Davis. In previous research, a similar drug helped reduce brain inflammation, prevent nerve cell damage, and improve memory in mice with an Alzheimer's-like condition.

  • A phase 1 clinical trial to examine the safety and efficacy in reducing brain inflammation of a novel therapy manufactured by Longeveron LLC using stem cells from healthy donors delivered into the bloodstream of people with mild Alzheimer’s disease. Anthony Oliva, PhD, senior scientist at Longeveron, will serve as principal investigator, and Bernard Baumel, MD, will serve as the clinical investigator of the trial at the University of Miami Miller School of Medicine in Florida. Past research demonstrated that this type of stem cell could target and reduce inflammation, promote tissue repair, and improve brain function in mouse models of Alzheimer’s disease.

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