A novel strategy using healthy plasma infusions led to promising results in patients with mild to moderate Alzheimer’s disease, Alkahest recently announced.
Stanford Medicine presented clinical data of its PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study (NCT02256306) Nov. 4 at the 10th Clinical Trials on Alzheimer’s Disease conference in Boston. The research — sponsored by Alkahest and Grifols, a producer of plasma therapies — was presented by Dr. Sharon Sha, a principal investigator and neurology professor at Stanford University.
“We are pleased to present these results from the PLASMA study, which demonstrate the safety of plasma-derived products and suggest their potential efficacy in Alzheimer’s,” Alkahest CEO Karoly Nikolich said in a press release. Like other studies, he said, the results support “the ability of plasma compositions to counteract the biological processes underlying neurodegeneration, and reaffirm our confidence in our pipeline of first-in-class products targeting the pathways implicated in age-related disease.”
The company, based in San Carlos, California, has already done preclinical studies in animal models of normal aging and disease — giving it hope that future studies of its proprietary lead clinical candidate will result in a treatment for mild to moderate Alzheimer’s.
The PLASMA study mainly determined the safety, tolerability and feasibility of repeated intravenous administrations of blood plasma from donors aged 18 to 30 years into patients with mild to moderate Alzheimer’s. The scientists also evaluated the therapy’s effect on multiple clinical assessments, including functional activity.
In the study, nine people were randomly assigned to treatment groups under a double-blind protocol, in which neither subject nor scientist knew which drug is being administered. Nine additional subjects were treated under an open-label protocol, in which the drug identity is revealed.
The plasma infusions were generally well tolerated. No treatment-related serious adverse events were reported. Importantly, the data also revealed a significant improvement in functional activity.