Phase 2Active, not recruitingAge-related condition
Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease (ExPlas)
Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease: The ExPlas Study
- Sponsor
- Norwegian University of Science and Technology (Academic or other)
- Enrollment
- 60 planned
- Conditions
- Alzheimer Disease
- Interventions
- ExPlas; Octaplasma; Saline
- Ages
- adults, older adults
- Registry
- NCT05068830, EUCTR2018-000148-24
Full record on ClinicalTrials.gov
From the registry
Introduction Given that exercise training reduces the risk of developing Alzheimer's disease (AD), induces changes in the blood composition and has widespread systemic benefits, it is reasonable to hypothesize that exercised plasma may have rejuvenative properties. The main objective is to test safety and tolerability of transfusing exercised plasma (ExPlas) from young, healthy, fit adults to patients with early AD. The study is a pilot for a future efficacy study. The key secondary objectives are examining the effect of plasma transfusions on cognitive function, fitness level, vascular risk profile, assessment of cerebral blood flow and hippocampal volume, quality of life, functional connectivity assessed by resting state functional MRI and biomarkers in blood and cerebrospinal fluid. Methods and analysis ExPlas is a double-blinded, randomized controlled clinical single center trial. Patients aged 50-75 years with diagnosis mild cognitive impairment or early AD will be recruited from two Norwegian hospitals. ExPlas is plasma drawn by plasmapheresis once a month for 4 months, from…
Primary outcomes
- Number of patients with adverse events
- Number of subjects who comply with the research protocol
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started