Alzheimer DiseasePhase 2ExPlasNCT05068830
Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease
A Phase 2 study testing ExPlas, Octaplasma and Saline in people with Alzheimer Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- ExPlas, Octaplasma and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 17 Sep 2021to 1 Mar 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient inclusion criteria:
- Diagnosis AD in early phase according to the IWG-2 criteria.
- Mini-Mental State Examination (MMSE) Score ≥20.
- In-vivo evidence of Alzheimer´s pathology (one of the following):
- Decreased Aβ42 together with increased t-tau or p-tau in CSF.
- Increased tracer retention on amyloid PET.
- Availability of a next of kin who knows the patient well and is willing to accompany the subject to all trial visits and give information about the patients functional level.
- Signed informed consent.
- The patient is judged fitted for the study and capable to cooperate in treatment and follow-up.
- Ability to communicate in Norwegian or another Scandinavian language.
Patient exclusion criteria:
- Pregnancy or unwilling to use adequate birth control for the duration of and 6 months beyond study participation. Defined according to Clinical Trial Facilitation Group document "Recommendations related to contraception and pregnancy testing in clinical trials".
- Positive for Hepatitis B, Hepatitis C or HIV at screening.
- Not qualified to give consent at inclusion.
- Any other condition judged to interfere with the safety of the patient or the intent and conduct of the study.
Related to medical history:
- Stroke
- Anaphylaxis
- Prior adverse reaction to any human blood product
- Any history of a blood coagulation disorder or hypercoagulability
- Congestive heart failure, defined as any previous heart failure hospitalization, or current symptomatic heart failure in New York heart Association class ≥II with reduced, mid-range or preserved ejection fraction.
- Coagulation defect or hypercoagulopathy
- Uncontrolled hypertension
- Renal failure
- Prior intolerance to intravenous fluids
- Recent history of uncontrolled atrial fibrillation
- Bone marrow transplant
- IgA deficiency
- Severe protein S deficiency
- Thrombocytopenia (platelets < 40 x 10 to the power of 9/L)
- Contraindication for Octaplasma
Related to medications or other treatments:
- Any concurrent use of anticoagulant therapy, clopidogrel or acetylsalicylic acid/Dipyridamol in combination.
- Initiation or change in the dosage of a acetylcholine esterase inhibitor (AChEI) or memantine during the trial (week 0-52). Participants will be urged to start on AChEI when diagnosis is communicated, and must be on a stable dose for at least one month prior to screening.
- Concurrent participation in another treatment trial for AD. If there was prior participation, the last dose of the investigational agent must have been given at least 6 months prior to screening, except if the patient received placebo medication.
- Treatment with any human blood product, including intravenous immunoglobulin, during the 6 months prior to screening or during the trial.
- Concurrent daily treatment with benzodiazepines, typical or atypical antipsychotics, long-acting opioids, or other medications that is judged to interfere with cognition. Intermittent treatment with short-acting benzodiazepines or atypical antipsychotics may be permitted, provided that no dose is administered within 72 hours prior to cognitive assessment.
Related to magnetic resonance imaging:
- Claustrophobia
- Any metallic surgical implant, like a pacemaker or clip that is incompatible with MRI.
Certain metallic implants like joint replacements may be permitted, provided that specific manufacturer specifications are available, and that the device is known to be safe for 7T MRI. In case a patient is not eligible for the 7T scanner, the 3T scanner will be used.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Neurology and Clinical Neurophysiology, St Olavs Hospital
Trondheim
About this study
Official title: Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease: The ExPlas Study
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).
- Conditions
- Alzheimer Disease
- Being tested
- ExPlas, Octaplasma, Saline
- Keywords
- Exercise therapy, Blood transfusion, Plasma
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExPlasDrug
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.
OctaplasmaDrug
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.
SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercised plasma (ExPlas) | Experimental | Dosage: 200 mL at every time point Dosage form: Solution for intravenous infusion Frequency of administration: 12 ExPlas transfusions during the time span of one year (weekly transfusions in 3 four-week periods) Receives: Drug: ExPlas |
| Octaplasma | Active comparator | Dosage: 200 mL at every time point Dosage form: Solution for intravenous infusion Frequency of administration: 12 Octaplasma transfusions during the time span of one year (weekly transfusions in 3 four-week periods) Receives: Drug: Octaplasma |
| Saline | Placebo comparator | Dosage: 200 mL at every time point Dosage form: Solution for intravenous infusion Frequency of administration: 12 saline infusions during the time span of one year (weekly transfusions in 3 four-week periods) Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
as a measure for safety and tolerability of the treatment
Measured: 1 year
Number of subjects who comply with the research protocol
as a measure for feasibility
Measured: 1 year
Secondary outcomes (22)
CERAD-test
Change in performance in the CERAD (The Consortium to Establish a Registry for Alzheimer's Disease) Ten word Test. CERAD Word List consists of three test parts; immediate recall, delayed recall and recognition. The scoring range for immediate recall is 0-30, for delayed recall 0-10 and for recognition 0-20. Higher scores indicate better learning performance, memory performance and recognition performance.
Measured: 1, 2 and 5 years
MMSE
Change in the Mini-Mental State Examination Score. An MMSE score of ≥20 is criteria for inclusion. Higher scores >28 indicate normal cognitive function. Scores in the middle range 25-27 may indicate cognitive impairment. Lower scores <24 indicate cognitive impairment.
Measured: 1, 2, and 5 years
Trail-Making test A and B
Change in performance in Trail-Making test A and B. The Trail Making Tests are scored by how long it takes to complete the tests. Norms for completion time variate with age and educational level. Longer completion time indicates impaired visual attention, processing speed and executive function.
Measured: 1, 2, and 5 years
Clock Drawing Test
Change in scores in the Clock Drawing Test. The Clock Drawing Test has a scoring range 0-5. Higher scores indicate normal cognitive function. Lower scores <4 may indicate cognitive impairment, spatial dysfunction or neglect.
Measured: 1, 2, and 5 years
Controlled Oral Word Association Test (COWAT)-FAS
Change in scores in Controlled Oral Word Association Test (COWAT)-FAS. Scoring is based on how many words the person produces within 1 minute. The minimum score is 0, and there is no maximum score. Higher scores indicate better verbal fluency. Scoring norms are based on the persons age and education level.
Measured: 1, 2, and 5 years
Visual Object and Space Perception (VOSP) Silhouettes
Change in scores in Visual Object and Space Perception (VOSP) Silhouettes. Visual Object and Space Perception (VOSP) Silhouettes has a scoring range 0-30. Higher scores > 20 indicate normal visuospatial function, and lower scores < 20 indicate visuospatial dysfunction.
Measured: 1, 2, and 5 years
Clinical Dementia Rating Scale Global score and Sum of Boxes
Change in Clinical Dementia Rating Scale Global score and Sum of Boxes. Clinical Dementia Rating Scale (CDR) is a clinical scale for the staging of dementia. The Global Score ranges dementia severity from 0-3. The Sum of Boxes ranges dementia severity from 0-18. Higher scores indicate more severe disease.
Measured: 1, 2, and 5 years
The Lawton Instrumental Activities of Daily Living Scale (IADL)
Change in The Lawton Instrumental Activities of Daily Living Scale (IADL). The Lawton Instrumental Activities of Daily Living Scale (IADL) evaluates the person's ability to perform complex everyday activities. The score ranges from 8-31. Higher scores indicate lower functional level.
Measured: 1, 2, and 5 years
6 minutes' walk test
Change in 6 minutes' walk-test
Measured: 1, 2, and 5 years
Functional MRI
Change in/Reduced hippocampal atrophy and preservation of functional connectivity assessed by resting state functional MRI. A secondary aim is to identify any effect of treatment group on MRI markers of both neurodegenerative and cerebrovascular disease.
Measured: 1, 2, and 5 years
SF-36
Quality of Life SF-36 Questionnaire. Computer-based scoring services for the SF-36v2 are available through QualityMetric™ or its licensed certified vendors.
Measured: 1, 2, and 5 years
Biomarker profile in blood
Change in biomarkers in blood (APOE). As there exist no single ideal biomarker of AD this endpoint is partly exploratory. Biological material will be stored for future analysis in the search for new biomarkers.
Measured: 1, 2, and 5 years
Biomarker profile in cerebrospinal fluid
Change in biomarkers in cerebrospinal fluid (Amyloid Beta 1-42, Amyloid Beta 1-40, phosphor tau and total tau). As there exist no single ideal biomarker of AD this endpoint is partly exploratory. Biological material will be stored for future analysis in the search for new biomarkers.
Measured: 1, 2, and 5 years
Echocardiography - Cardiac dimensions - Left ventricular end diastolic diameter
Changes in cardiac dimensions - left ventricular end diastolic diameter (mm).
Measured: 1, 2, and 5 years
Echocardiography - Cardiac dimensions - Right ventricular dimension
Changes in cardiac dimensions - right ventricular dimension (mm).
Measured: 1, 2, and 5 years
Echocardiography - Cardiac volumes - Left ventricular and diastolic volume.
Changes in cardiac volumes - left ventricular and diastolic volume (mL).
Measured: 1, 2, and 5 years
Echocardiography - Cardiac volumes - Right ventricular volume
Changes in cardiac volumes. Right ventricular volume (mL).
Measured: 1, 2, and 5 years
Echocardiography - Functional indices - Ejection fraction
Changes in functional indices - ejection fraction (%).
Measured: 1, 2, and 5 years
Echocardiography - Functional indices - Left ventricular strain
Changes in functional indices - left ventricular strain (%).
Measured: 1, 2, and 5 years
Echocardiography - Functional indices - Ventricular velocity
Changes in functional indices - ventricular velocity (cm/s).
Measured: 1, 2, and 5 years
Echocardiography - Functional indices - Right ventricular strain
Changes in functional indices - right ventricular strain (%).
Measured: 1, 2, and 5 years
Echocardiography - Functional indices - Left ventricular stiffness
Changes in functional indices - left ventricular stiffness.
Measured: 1, 2, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start17 Sep 2021
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded, randomized controlled clinical phase II trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisløff, PhD, Prof, Principal investigator, Cardiac Exercise Research Group at the Department of Circulation and Medical Imaging, NTNUSigrid Botne Sando, MD, PhD, Principal investigator, Department of Neurology and Clinical Neurophysiology, St. Olavs University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068830
- Sponsor's protocol ID
- 2018/702
- Other IDs
- 2018-000148-24, 2018
- Acronym
- ExPlas
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2021
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be decided
Publications
Tari AR, Berg HH, Videm V, Brathen G, White LR, Rosbjorgen RN, Scheffler K, Dalen H, Holte E, Haberg AK, Selbaek G, Lydersen S, Duezel E, Bergh S, Logan-Halvorsrud KR, Sando SB, Wisloff U. Safety and efficacy of plasma transfusion from exercise-trained donors in patients with early Alzheimer's disease: protocol for the ExPlas study. BMJ Open. 2022 Sep 6;12(9):e056964. doi: 10.1136/bmjopen-2021-056964.
PubMed 36538409
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease: The ExPlas Study
- ClinicalTrials.gov ID
- NCT05068830
- Acronym / sponsor ID
- ExPlas / 2018/702
- Conditions
- Alzheimer Disease
- Keywords
- Exercise therapy, Blood transfusion, Plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Double blinded, randomized controlled clinical phase II trial
| Arm | Type | Receives |
|---|---|---|
| Exercised plasma (ExPlas) | Experimental | Drug: ExPlasDosage: 200 mL at every time point Dosage form: Solution for intravenous infusion Frequency of administration: 12 ExPlas transfusions during the time span of one year (weekly transfusions in 3 four-week periods) |
| Octaplasma | Active comparator | Drug: OctaplasmaDosage: 200 mL at every time point Dosage form: Solution for intravenous infusion Frequency of administration: 12 Octaplasma transfusions during the time span of one year (weekly transfusions in 3 four-week periods) |
| Saline | Placebo comparator | Drug: SalineDosage: 200 mL at every time point Dosage form: Solution for intravenous infusion Frequency of administration: 12 saline infusions during the time span of one year (weekly transfusions in 3 four-week periods) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExPlasExPlas (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 | Exercised plasma (ExPlas) |
| OctaplasmaOctaplasma 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 | Octaplasma |
| SalineSaline 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. | Drug | Saline |
Primary outcome
Number of patients with adverse events
Time frame: 1 year
as a measure for safety and tolerability of the treatment
Number of subjects who comply with the research protocol
Time frame: 1 year
as a measure for feasibility
22 secondary outcomes
CERAD-test
Time frame: 1, 2 and 5 years
MMSE
Time frame: 1, 2, and 5 years
Trail-Making test A and B
Time frame: 1, 2, and 5 years
Clock Drawing Test
Time frame: 1, 2, and 5 years
Controlled Oral Word Association Test (COWAT)-FAS
Time frame: 1, 2, and 5 years
Visual Object and Space Perception (VOSP) Silhouettes
Time frame: 1, 2, and 5 years
Clinical Dementia Rating Scale Global score and Sum of Boxes
Time frame: 1, 2, and 5 years
The Lawton Instrumental Activities of Daily Living Scale (IADL)
Time frame: 1, 2, and 5 years
6 minutes' walk test
Time frame: 1, 2, and 5 years
Functional MRI
Time frame: 1, 2, and 5 years
SF-36
Time frame: 1, 2, and 5 years
Biomarker profile in blood
Time frame: 1, 2, and 5 years
Biomarker profile in cerebrospinal fluid
Time frame: 1, 2, and 5 years
Echocardiography - Cardiac dimensions - Left ventricular end diastolic diameter
Time frame: 1, 2, and 5 years
Echocardiography - Cardiac dimensions - Right ventricular dimension
Time frame: 1, 2, and 5 years
Echocardiography - Cardiac volumes - Left ventricular and diastolic volume.
Time frame: 1, 2, and 5 years
Echocardiography - Cardiac volumes - Right ventricular volume
Time frame: 1, 2, and 5 years
Echocardiography - Functional indices - Ejection fraction
Time frame: 1, 2, and 5 years
Echocardiography - Functional indices - Left ventricular strain
Time frame: 1, 2, and 5 years
Echocardiography - Functional indices - Ventricular velocity
Time frame: 1, 2, and 5 years
Echocardiography - Functional indices - Right ventricular strain
Time frame: 1, 2, and 5 years
Echocardiography - Functional indices - Left ventricular stiffness
Time frame: 1, 2, and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 36538409Tari AR, Berg HH, Videm V, Brathen G, White LR, Rosbjorgen RN, Scheffler K, Dalen H, Holte E, Haberg AK, Selbaek G, Lydersen S, Duezel E, Bergh S, Logan-Halvorsrud KR, Sando SB, Wisloff U. Safety and efficacy of plasma transfusion from exercise-trained donors in patients with early Alzheimer's disease: protocol for the ExPlas study. BMJ Open. 2022 Sep 6;12(9):e056964. doi: 10.1136/bmjopen-2021-056964.
- Individual participant dataSharing planned: Yes. To be decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik Wisløff, PhD, Prof principal investigator
Cardiac Exercise Research Group at the Department of Circulation and Medical Imaging, NTNU
Sigrid Botne Sando, MD, PhD principal investigator
Department of Neurology and Clinical Neurophysiology, St. Olavs University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ExPlas, Octaplasma and Saline in people with Alzheimer Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05068830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.