Alzheimer's Association awards $3 million grant to support Longeveron's innovative clinical trial

The Alzheimer's Association has awarded Longeveron LLC, a Miami-based biopharmaceutical company that develops cellular therapies for aging-related diseases, a $3 million grant to be applied to the company's mesenchymal stem cell Alzheimer's research.

The prestigious competitive grant was awarded to Longeveron's Anthony Andrew Oliva, Ph.D., and colleagues to help them continue their research project using adult stem cells to target neuroinflammation in individuals with mild Alzheimer's disease. Chronic inflammation in the brain may harm healthy cells and be one of the causes of Alzheimer's disease and other brain diseases, including Amyotrophic Lateral Sclerosis (ALS), Parkinson's disease, and vascular dementia.

Dr. Oliva had a poster presentation on the progress of the research at the Alzheimer's Association International Conference (AAIC) 2019 in Los Angeles.

"The Alzheimer's Association's Part the Cloud Challenge on Neuroinflammation grant demonstrates validation of our clinical development of regenerative stem cell therapies for aging-related diseases," said Geoff Green, President of Longeveron. "We have seen in our Aging Frailty clinical trials the potential of stem cells to reduce inflammation, which has been identified as a potential factor in the progression and acuity of Alzheimer's disease. We are honored to be named as a recipient and would not be as far along in our Alzheimer's stem cell clinical research without this major support from the Alzheimer's Association."

The Alzheimer's Association's Part the Cloud global research grant program was created to identify promising targets for new therapies for Alzheimer's disease and to provide funding for early stage clinical studies that often have difficulty finding financial support from other sources. The goal is to accelerate the development of new therapies to slow, stop or prevent the progression of Alzheimer's disease.

The Part the Cloud Challenge on Neuroinflammation is a competitive process. The Longeveron research was originally funded at $1 million for two years and after that period was chosen as the most promising which has resulted in the awarding of the additional $3 million challenge grant to extend the research. Since 2012, Part the Cloud has generated over $30 million in funding for Alzheimer's research and awarded 34 research grants.

The Part the Cloud grants provide the necessary funding for high risk, but highly promising early stage research that the Alzheimer's Association is committed to advancing. We are excited to support Longeveron's innovative clinical trial because we need these types of trials, to find better preventions and treatments for Alzheimer's."

Maria C. Carrillo, Ph.D., chief science officer, Alzheimer's Association

Longeveron is currently recruiting for a Phase 1 clinical trial to evaluate the safety and efficacy of its Mesenchymal Stem Cells (MSC) in patients diagnosed with Alzheimer's disease. The randomized, placebo-controlled, double-blinded trial involves a total of about 30 participants at four trial sites, the University of Miami Miller School of Medicine, Miami Jewish Health Systems, The Neurology Group in Kendall, Florida, and Brain Matters Research in Delray Beach, Florida. The company's MSC product is derived from the bone marrow of young, healthy adult donors.

According to Dr. Oliva, principal investigator of Longeveron's Alzheimer's trial, researchers are looking to assess efficacy of the stem cell treatments by examining changes in Alzheimer's disease status in several areas. These include neurological and neurocognitive assessments; quality of life assessments; evaluation of blood inflammatory biomarkers; and evaluation of cerebrospinal fluid (CSF) inflammatory biomarkers and those for Tau and Beta-amyloid, the biomarkers of Alzheimer's.

"We are hopeful that our research in regenerative medicine will show that controlling inflammation and other disease facets holds a critical key to a breakthrough in ameliorating the devastating effects of Alzheimer's," Oliva said.

According to Alzheimer's Association's Facts and Figures, the number of people age 65 and older with Alzheimer's dementia is estimated to reach 7.2 million by 2025, an increase of 28% from the 5.6 million affected in 2019. Barring any medical breakthroughs, the number of people age 65 and older with Alzheimer's dementia may nearly triple to nearly 14 million by 2050.