A small clinical trial (PLASMA) by Stanford University School of Medicine in the US has demonstrated the safety of blood-plasma infusions from young donors to patients with mild to moderate Alzheimer’s disease.
The early phase trial evaluated the safety, tolerability, and feasibility of the infusions. It is reported to have indicated some evidence of improvement in the condition of patients.
PLASMA was led by Stanford University neurology and neurological sciences clinical associate professor Sharon Sha, who said that the recipients showed improvements on tests of functional ability.
The trial was based on a preclinical research by Sha’s colleague Tony Wyss-Coray indicating the use of blood of young mice to rejuvenate brain tissue and improve cognitive performance in older mice.
Funded by US-based biotechnology firm Alkahest, the trial included two stages, of which the first included nine patients administered over four weeks with the infusions from donors aged 18-30 years, or placebo.
Following a six-week washout period, the four-week second stage involved reversed infusion of the blood-plasma and placebo.
Multiple tests were conducted to assess mood, cognition and functional ability of the patients before and after the first and second stages.
While the trial did not reveal any significant changes in mood and cognition, a statistically significant improvement was observed with functional ability assessments.
As the trial included only 18 subjects, investigators believe that further assessment is required to establish a conclusion on the efficacy of the infusions.
Alkahest co-founder Wyss-Coray said: "I’m excited to see that giving repeated infusions of plasma to elderly people with Alzheimer’s disease is safe and that we can move forward to larger studies.
"But I’m also realistic enough to know that it is very easy to cure diseases in small animals and a million times more difficult in humans."
The firm holds the intellectual property related for the treatment regimen.