Sha SJ, et al. - Researchers performed a randomized clinical trial to examine the safety, tolerability, and feasibility of infusions of young fresh frozen plasma (yFFP) from donors age 18 to 30 years in patients with Alzheimer disease (AD). As per outcomes, the yFFP treatment was safe, well tolerated, and feasible among patients with mild to moderate Alzheimer disease dementia.

Methods

• Under a double-blind crossover protocol, nine patients were randomized to receive four once-weekly infusions of either one unit (approximately 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.
• Treatment and subjective measurements were not revealed to patients and informants.
• 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, researchers enrolled patients solely at Stanford University, a tertiary academic medical center.
• They enrolled 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).
• The safety, tolerability, and feasibility of 4 weekly yFFP infusions were assessed as the primary outcomes.
• All patients who received the study drug/placebo underwent safety end point analyses.

Results

• The crossover (n = 9) and open-label groups (n = 9) were not different in terms of 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]).
• No related serious adverse events were evident.
• One patient stopped participating because of urticaria and another because of an unrelated stroke.
• The plasma (17 [94.4%]) and placebo (9 [100.0%]) cohorts showed no statistically significant difference for other adverse events, which were mild to moderate in severity.
• The plasma group had hypertension (3 [16.7%]), dizziness (2 [11.1%]), sinus bradycardia (3 [16.7%]), headache (3 [16.7%]), and sinus tachycardia (3 [16.7%]) as the most common adverse events.
• Researchers noted the mean visit adherence (n = 18) of 86% (interquartile range, 87%-100%) and adherence, accounting for a reduction in the total visit requirement due to early patient discontinuation, of 96% (interquartile range, 89%-100%).