The study (NCT03765762) was designed to assess the safety and tolerability of the experimental treatment, as well as its impact on patients’ mental state and capacity to perform daily activities. Researchers will also collect information on overall symptom changes as reported by patients and their caregivers.
The trial is currently recruiting at sites in Arizona and Florida in the United States. Up to 20 participants with severe Alzheimer’s disease, as defined by Mini-Mental State Examination scores between 0 and 10, will be randomized to receive daily intravenous infusions of GRF6019 or a placebo for five consecutive days and followed for up to nine weeks.
Alkahest, and its collaborator Grifols, expect to announce results from this Phase 2 trial during the second half of 2020. For more information about the study, such as clinical site locations and contacts, click here.
“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,” Karoly Nikolich, PhD, chairman and CEO of Alkahest, said in a press release.
GRF6019 is an investigational therapy that resulted from the separation of certain proteins from human blood plasma. Blood proteins that promote adverse immune reactions or treatment-patient incompatibilities — such as antibodies and clotting factors — are removed from GRF6019. Researchers believe this depletion process enhances the treatment’s safety and tolerability, and eases its administration. The therapy is also not restricted by blood type matching and is optimized for therapeutic uses.
Preclinical studies have shown that treatment with GRF6019 can improve learning and memory, reduce neuroinflammation, and support brain cells’ health in aged mice, which suggests that the product may hold therapeutic activity for several human neurological disorders, including Alzheimer’s disease.
In a previous open-label trial, called PLASMA (NCT02256306), researchers found that repeated intravenous infusions of plasma from young adult donors, 18 to 30 years old, into patients with mild to moderate Alzheimer’s could significantly improve functional activity in the patients.
“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,” Nikolich said. “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.”
Alkahest and Grifols are currently assessing the potential of GRF6019 in a second Phase 2 study (NCT03520998) in 40 patients with mild to moderate Alzheimer’s disease. Results from this study are expected to be announced by the end of 2019.
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