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Study on the Safety and Effects of Plasma Transfusion from Exercise-Trained Donors in Patients with Early Alzheimer’s Disease Using Human Plasma Protein and Saline

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What is this study about?

The ExPlas Study is focused on understanding the safety and effectiveness of a treatment for patients with early Alzheimer’s disease. This study involves the use of a treatment called plasma transfusion, which is derived from donors who have undergone exercise training. Plasma is a component of blood that contains important proteins and other substances. The study aims to see if this treatment can be safe and well-tolerated by patients.

Participants in the study will receive the treatment through a method called intravenous infusion, which means the plasma is given directly into the bloodstream through a vein. The study will last for about one year, during which the health and well-being of the participants will be closely monitored. The main goal is to observe any side effects and to ensure that the treatment is feasible for patients to undergo.

In addition to monitoring safety, the study will also look at changes in cognitive abilities, which are mental processes like memory and thinking. This will be done using various tests, such as the Mini-Mental State Examination (MMSE) and other cognitive assessments. The results will help determine if the plasma transfusion has any impact on the progression of Alzheimer’s disease symptoms. The study is expected to continue until 2030, providing valuable insights into this potential treatment option.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the trial. These assessments may include cognitive tests and medical evaluations to ensure you meet the study criteria.

2 treatment phase

During the treatment phase, you will receive **intravenous infusions**. The infusions will include **saline** and **human plasma protein**. The specific product names are **Saline (NaCl)** and **Octaplasma 45-70 mg/ml**. These infusions will be administered through a vein.

The frequency and duration of the infusions will be determined by the study protocol. You will be informed of the schedule and any specific instructions you need to follow during this phase.

3 follow-up visits

Throughout the study, you will attend regular follow-up visits. These visits are designed to monitor your health and assess the effects of the treatment. You will undergo various tests, including cognitive assessments, to evaluate any changes in your condition.

The follow-up visits will also provide an opportunity to discuss any side effects or concerns you may have with the study team.

4 final assessment

At the end of the study period, you will have a final assessment. This will include a comprehensive evaluation of your health and cognitive function. The results will help determine the overall safety and effectiveness of the treatment.

You will receive information about the findings and any further steps, if necessary, after the study concludes.

Who Can Join the Study?

  • Must provide a signed informed consent, which means you agree to participate after understanding the study.
  • Must be up to 75 years old.
  • Must have a diagnosis of Alzheimer’s disease in the early phase, according to specific medical guidelines.
  • Must have decreased levels of a protein called Aβ42 and increased levels of proteins called t-tau or p-tau in the cerebrospinal fluid (CSF), which is the fluid around the brain and spine.
  • Must show increased tracer retention on an amyloid Positron Emission Tomography (PET) scan, which is a type of brain scan.
  • Must have a Mini-Mental State Examination (MMSE) score of 20 or higher. This is a test that measures cognitive function.
  • Must have a next of kin, like a family member or close friend, who knows you well and is willing to accompany you to all trial visits and provide information about your daily functioning.
  • Must be considered fit to participate and able to take part in the treatment and follow-up procedures.
  • Must be able to communicate in Norwegian or another Scandinavian language.

Who Cannot Join the Study?

  • Patients who do not have early symptomatic phase Alzheimer’s disease cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are unable to comply with the research protocol cannot participate.
  • Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Nnasydqro Uonftrzcog Ol Sbonpmn Amt Tsooaunrnnkp Trondheim Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Not recruiting
15.09.2021

Trial locations

Investigated drugs:

Plasma Transfusion from Exercise-Trained Donors
This therapy involves giving patients plasma, which is a part of blood, from donors who regularly exercise. The idea is that the plasma from these healthy, active donors might have special properties that could help people with early Alzheimer’s disease. The study is looking at whether this type of plasma transfusion is safe and if it can help improve the condition of patients with Alzheimer’s.

Investigated diseases:

Alzheimer’s Disease – Alzheimer’s disease is a progressive neurological disorder that affects memory, thinking, and behavior. In its early symptomatic phase, individuals may experience mild memory loss and confusion, which gradually worsen over time. As the disease progresses, it leads to significant impairments in cognitive functions, including difficulties with language, problem-solving, and performing familiar tasks. Behavioral changes, such as mood swings, irritability, and social withdrawal, may also occur. Eventually, individuals may require assistance with daily activities and experience severe memory loss. The progression of Alzheimer’s disease varies among individuals, but it generally leads to a decline in the ability to function independently.

Trial ID:
2024-518668-11-01
Protocol code:
ExPlas
NCT ID:
NCT05068830
Trial Phase:
Therapeutic exploratory (Phase II)

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