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ExPlas

Safety and efficacy of plasma transfusion from exercise-trained donors in patients with early Alzheimer's disease

Sponsor
Norwegian University of Science and Technology
Phase
Drug
Exercised plasma
Countries

Information about the drug that will be tested in the study

Name of the drug

Exercised plasma (ExPlas). It is a transfusing exercised plasma from young, healthy, fit men to people with early phase Alzheimer's disease.

Administration

The drug will be administered via an intravenous infusion (an injection into the vein) 12 times during one year.

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

Participants will be selected at random to either receive one of the following options:

  • An intravenous injection of ExPlas (200 mL)
  • An intravenous injection of Octaplasma (200 mL). It is a blood specific solution containing human plasma proteins
  • An intravenous injection of placebo (saline), also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect.

Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the safety, tolerability and efficacy of ExPlas in people with early Alzheimer’s disease.

How long will the treatment last?
  • Transfusion during 1 year
  • Follow-up examinations after 2 and 5 years is also planned.
What your involvement will entail?
  • During the study, participants will be asked to complete some tests that will access recall, recognition, executive function, verbal fluency, activities of daily living and cognition (i.e. CERAD, MMSE, COWAT-FAS, IADL)
  • Participants will be asked to undertake brain scans (MRI) and lumbar punctures (CSF) to see changes in biomarkers in the brain
  • Complete some laboratory tests such as blood tests and echocardiography (heart).

    Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in the study?

To take part in the study, participants must:

  • Be between 50 and 75 years old
  • Have a diagnosis of Alzheimer’s disease according to the IWG-2 criteria
  • Have a score above 20 in the MMSE test (a test about your memory). This would suggest that the person has an impairment in their memory that is at a mild to moderate stage
  • Have evidence of Alzheimer’s pathology such as abnormal accumulation of amyloid and Tau in their brain (CSF or Amyloid PET)e
  • Have a study partner who has a sufficient contact with the participant is willing to participate in study procedures throughout the study duration
  • Ability to communicate in Norwegian or another Scandinavian language
  • Must live close to the study site (Trondheim).
Who cannot participate in the study?

Exclusion criteria include:

  • Pregnancy
  • Positive for Hepatitis B, Hepatitis C or HIV
  • A disease or conditions that may interfere with the safety, tolerability and/or study assessments, or put the participant at special risk (e.g. psychiatric symptoms, auto-immune disease, inflammatory neurological disorders, stroke)
  • Current participation in other clinical studies for Alzheimer’s disease
  • Use of anticoagulant therapy, daily treatment with benzodiazepines, typical or atypical antipsychotics
  • Not able to perform cerebral brain scans (MRI).

The above list is not exhaustive.

Information for your doctor

EudraCT Number

2018-000148-24

Clinicaltrials.gov identifier

NCT05068830

Study contact information

  sigrid.b.sando@ntnu.no

Link to full text

https://clinicaltrials.gov/ct2/show/NCT05068830

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on March 2022.

This document has been reviewed by the responsible persons for this trial.

Click here to download the accessible easy-to-read version of this document

Attachments
Document
ExPlas study.pdf (167.17 KB)
 
Acknowledgement

Alzheimer Europe's Clinical Trials Watch database was developed as part of the 2018 Work Plan which received funding under an operating grant from the European Union’s Health Programme (2014–2020).

Alzheimer Europe gratefully acknowledges the support of its corporate sponsors for the update and maintenance of the database.

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