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In a phase 2 clinical trial (NCT03765762), the first participant has received a dose of the proprietary plasma fraction (PPF)(GRF6019) developed by Alkahest (San Carlos, CA) in partnership with Grifols (Barcelona, Spain).
Approximately 20 participants with severe AD (score of 0-10 on Mini-Mental State Examination [MMSE]) will be given the PPF for 5 consecutive days and then followed for 9 weeks. The aim of the study is to evaluate safety and efficacy and potential functional benefit of the PPF. Functional benefit will be evaluated with the MMSE and other measures of cognition, memory, and behavior. The PPFs being tested target plasma proteome of people with neurodegenerative diseases. In animal models, PPFs increased neurogenesis, improved age-related deficits in learning and memory, and reduced neuroinflammation.
“In recent years, it has become evident that there is a complex, multifactorial pathology underlying Alzheimer’s disease that available drugs and those currently in development fail to fully address,” said Karoly Nikolich, PhD, chairman and chief executive officer of Alkahest. “Using our deep understanding of the plasma proteome, we have identified specific proteomic factors as the basis for this potential treatment for Alzheimer’s disease. Patients at more advanced stages of Alzheimer’s disease are rarely included in clinical trials, and this novel approach could provide a novel treatment option for these individuals.” Another phase 2 study (NCT03520998) of the same proprietary plasma fraction is ongoing in participants with mild-to-moderate Alzheimer’s disease (AD) with data expected in 2019. Another PPF (GRF6021, Alkahest) is being studied (NCT03713957) for potential treatment of people who have Parkinson’s disease-related cognitive impairments.
Joshua D. Grill, PhD
Janel Schneider, MD