Sha SJ, et al. - In patients with Alzheimer disease (AD), researchers evaluated the safety, tolerability, and feasibility of infusions of young fresh frozen plasma (yFFP) from donors between the ages of 18 and 30. Hypertension, dizziness, sinus bradycardia, headache, and sinus tachycardia were the most common adverse events in the plasma group. Among patients with mild to moderate Alzheimer disease dementia, the yFFP treatment was safe, well tolerated and feasible.

Methods

• Under a double-blind crossover protocol, nine patients were randomized to receive four once-weekly infusions of either one unit (nearly 250 mL) of yFFP from male donors or 250 mL of saline, followed by a 6-week washout and crossover to four once-weekly infusions of an alternate treatment, in the Plasma for Alzheimer Symptom Amelioration (PLASMA) study.
• Informants and patients were masked for treatment and subjective measurements.
• Four weekly yFFP infusions were given to nine patients after an open-label amendment and their subjective measurements were unmasked.
• From September 2014 to December 2016, investigators enrolled patients solely at Stanford University, a tertiary academic medical center.
• They recruited 18 consecutive patients with probable mild to moderate AD dementia, a Mini-Mental State Examination (score of 12 to 24 inclusive) and aged 50 to 90 years.
• Screening of 31 patients was done and 13 were excluded (11 failed the inclusion criteria and 2 declined to participate).
• For this investigation, one unit of yFFP from male donors/placebo infused once weekly for 4 weeks.
• All patients who received the study drug/placebo underwent safety end point analyses.

Results

• No difference in the age (mean [SD], 74.17 [7.96] years), sex (12 women [67%]), or baseline Mini-Mental State Examination score (mean [SD], 19.39 [3.24]) between the crossover (n = 9) and open-label groups (n = 9) was found.
• No related serious adverse events were evident.
• One patient stopped taking part due to hives and another due to an unrelated stroke.
• No statistically significant difference between the plasma (17 [94.4%]) and placebo (9 [100.0%]) cohorts for other adverse events was found, which were mild to moderate in severity.
• Hypertension (3 [16.7%]), dizziness (2 [11.1%]), sinus bradycardia (3 [16.7%]), headache (3 [16.7%]), and sinus tachycardia (3 [16.7%]) were the most common adverse events in the plasma group.
• They discovered that the mean visit adherence (n = 18) was 86% (interquartile range, 87%-100%) and adherence, accounting for a reduction in the total visit requirement due to early patient discontinuation, was 96% (interquartile range, 89%-100%).