Clinical Trials Logo

Clinical Trial Summary

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 a total of 30 donors (aged 18-40, BMI ≤27 kg/m2 and VO2max >50 mL/kg/min). All units will be virus inactivated by the Intercept method in accordance with procedures at St. Olavs Hospital. Comparison with isotonic saline allows differentiation from a non-blood product. The main study consists of 6 rounds of examinations in addition to 12 plasma transfusions divided over three 4-weeks periods during study year-1. Follow-up examinations after 2 and 5 years after baseline is also planned. Ethics and dissemination Written informed consent will be obtained from all participants and participation is voluntary. All participants have a next of kin who will follow them throughout the study and represent the patient's interest. The study is approved by the Regional Committee for Medical and Health Research Ethics (REK 2018/702) and the Norwegian Medicines Agency (EudraCT No. 2018-000148-24).

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05068830
Study type Interventional
Source Norwegian University of Science and Technology
Contact Atefe R. Tari
Phone +47 48079041
Email [email protected]
Status Recruiting
Phase Phase 2
Start date September 17, 2021
Completion date September 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Completed NCT04079803 - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Terminated NCT03672474 - REGEnLIFE RGn530 - Feasibility Pilot N/A
Active, not recruiting NCT03430648 - Is Tau Protein Linked to Mobility Function?
Completed NCT03239561 - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants Early Phase 1
Completed NCT03184467 - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients Phase 2
Recruiting NCT04606420 - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease Phase 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Recruiting NCT03487380 - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease N/A
Recruiting NCT04149860 - Study With Lu AF87908 in Healthy Subjects and Patients With Alzheimer's Disease Phase 1
Withdrawn NCT02707978 - F 18 T807 Tau PET Imaging of Frontotemporal Dementia (FTD) Phase 2
Not yet recruiting NCT03208491 - [email protected]: Economic Assessment of Serious Games for the Management of Alzheimer's Disease and Related Disorders N/A
Recruiting NCT04604600 - Multimodal Biomarkers for Diagnosis and Prognosis in VCI Phase 3
Recruiting NCT04567745 - Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Phase 1
Recruiting NCT04488419 - ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease Phase 2
Completed NCT04571697 - A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
Recruiting NCT03671889 - ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease N/A
Recruiting NCT03056495 - Clinical Trial to Determine Tolerable Dosis of Vorinostat in Patients With Mild Alzheimer Disease Phase 1
Recruiting NCT03991624 - Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences N/A