ExPlas

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

Conditions

Sponsor

Norwegian University of Science and Technology

Phase

Status

Drug

Exercised plasma

Countries

Norway

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

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

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.

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

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.

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).

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.