Young Fresh Frozen Plasma Infusion Safe, Feasible in Alzheimer Disease
Investigators suggest further studies that use measures designed to detect change during the duration of treatment and that can potentially verify efficacy.
Infusions of young fresh frozen plasma (yFFP) from healthy donors 18 to 30 years old were well tolerated and safe when used in patients with Alzheimer disease (AD), according to study results published in JAMA Neurology. Although feasible, the trial did not report on the efficacy of this treatment approach for the prevention or treatment of AD.
A total of 9 patients with mild to moderate AD (age range, 50-90 years) from a tertiary academic medical center were randomly assigned to 4 once-weekly infusions of either 1 unit of 250 mL yFFP from male donors or 250 mL saline. This infusion stage was followed by a 6-week washout period as well as crossover to 4 once-weekly infusions of an alternate therapy and then another 6-week washout. In an open-label phase of the study, another 9 patients received a total of 4 weekly yFFP infusions. Safety, tolerability, and feasibility of a once-weekly plasma infusion comprised the primary outcome. Feasibility of the treatment approach was determined by adherence to completed visits divided by total scheduled visits.
The study investigators observed no treatment-related adverse events (TRAEs) during the crossover or open-label study phases. An unrelated stroke and urticaria each resulted in study discontinuation in 1 patient. There was no significant difference between the plasma infusion and placebo groups with regard to other TRAEs (94.4% vs 100.0%, respectively), all of which were deemed to exhibit mild to moderate severity. The most frequently reported TRAEs in patients receiving yFFP were hypertension (16.7%), dizziness (11.1%), sinus bradycardia (16.7%), headache (16.7%), and sinus tachycardia (16.7%). Visit adherence and adherence were both high (86% [interquartile range, 87%-100%] vs 96% [interquartile range, 89%-100%], respectively).
Limitations of the study included the small sample size, limited follow-up duration, and the use of patients from only 1 center in the United States.
Findings from this small trial "warrant further exploration in larger double-blinded clinical trials that use measures that are designed to detect change within the treatment time frame and are powered to determine efficacy."
Sha SJ, Deutsch GK, Tian L, et al. Safety, tolerability, and feasibility of young plasma infusion in the plasma for Alzheimer symptom amelioration study: a randomized clinical trial [published online October 29, 2018]. JAMA Neurol. doi: 10.1001/jamaneurol.2018.3288