Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 17, 2021

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2026

Conditions
Alzheimer Disease
Interventions
DRUG

ExPlas

"ExPlas (plasma from fit donors) is a Investigational Medicinal Product. ExPlas is plasma drawn by plasmapheresis once a month for 4 months, from a total of 30 donors (aged 18-40, BMI ≤27 kg/m2 and VO2max \>50 mL/kg/min) at the Blood Bank at St. Olavs Hospital. All unites will be virus inactivated by the Intercept method (Cerus corporation, US) in accordance with the procedures at Blood Bank at St. Olavs Hospital.~The transfusion volume will be 200 mL at every time point.~The main study consists of 6 rounds of examinations in addition to 12 plasma transfusions during the time span of one year (weekly transfusions in 3 four-week periods) and one round of examinations 2 years after baseline. A follow-up visit is also planned 5 years after baseline."

DRUG

Octaplasma

"Octaplasma is defined as a Investigational Medicinal Product. Octaplasma is human pooled plasma produced by Octapharma (Lachen, Switzerland). The transfusion volume will be 200 mL at every time point .~The main study consists of 6 rounds of examinations in addition to 12 plasma transfusions during the time span of one year (weekly transfusions in 3 four-week periods) and one round of examinations 2 years after baseline. A follow-up visit is also planned 5 years after baseline."

DRUG

Saline

"Saline is provided by the hospital pharmacies in Central Norway. The infusion volume will be 200 mL at every time point.~The main study consists of 6 rounds of examinations in addition to 12 saline infusions during the time span of one year (weekly transfusions in 3 four-week periods) and one round of examinations 2 years after baseline. A follow-up visit is also planned 5 years after baseline."

Trial Locations (1)

Unknown

RECRUITING

Department of Neurology and Clinical Neurophysiology, St Olavs Hospital, Trondheim

All Listed Sponsors
collaborator

St. Olavs Hospital

OTHER

lead

Norwegian University of Science and Technology

OTHER