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Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease (ExPlas)

Primary Purpose

Alzheimer Disease

Status
Recruiting
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
ExPlas
Octaplasma
Saline
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Exercise therapy, Blood transfusion, Plasma

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurology and Clinical Neurophysiology, St Olavs HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Exercised plasma (ExPlas)

Octaplasma

Saline

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

Number of patients with adverse events
as a measure for safety and tolerability of the treatment
Number of subjects who comply with the research protocol
as a measure for feasibility

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
6 minutes' walk test
Change in 6 minutes' walk-test
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.
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.
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.
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.
Echocardiography - Cardiac dimensions - Left ventricular end diastolic diameter
Changes in cardiac dimensions - left ventricular end diastolic diameter (mm).
Echocardiography - Cardiac dimensions - Right ventricular dimension
Changes in cardiac dimensions - right ventricular dimension (mm).
Echocardiography - Cardiac volumes - Left ventricular and diastolic volume.
Changes in cardiac volumes - left ventricular and diastolic volume (mL).
Echocardiography - Cardiac volumes - Right ventricular volume
Changes in cardiac volumes. Right ventricular volume (mL).
Echocardiography - Functional indices - Ejection fraction
Changes in functional indices - ejection fraction (%).
Echocardiography - Functional indices - Left ventricular strain
Changes in functional indices - left ventricular strain (%).
Echocardiography - Functional indices - Ventricular velocity
Changes in functional indices - ventricular velocity (cm/s).
Echocardiography - Functional indices - Right ventricular strain
Changes in functional indices - right ventricular strain (%).
Echocardiography - Functional indices - Left ventricular stiffness
Changes in functional indices - left ventricular stiffness.

Full Information

First Posted
September 13, 2021
Last Updated
September 30, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05068830
Brief Title
Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease
Acronym
ExPlas
Official Title
Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease: The ExPlas Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Exercise therapy, Blood transfusion, Plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double blinded, randomized controlled clinical phase II trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercised plasma (ExPlas)
Arm Type
Experimental
Arm Description
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)
Arm Title
Octaplasma
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
ExPlas
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Octaplasma
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with adverse events
Description
as a measure for safety and tolerability of the treatment
Time Frame
1 year
Title
Number of subjects who comply with the research protocol
Description
as a measure for feasibility
Time Frame
1 year
Secondary Outcome Measure Information:
Title
CERAD-test
Description
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.
Time Frame
1, 2 and 5 years
Title
MMSE
Description
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.
Time Frame
1, 2, and 5 years
Title
Trail-Making test A and B
Description
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.
Time Frame
1, 2, and 5 years
Title
Clock Drawing Test
Description
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.
Time Frame
1, 2, and 5 years
Title
Controlled Oral Word Association Test (COWAT)-FAS
Description
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.
Time Frame
1, 2, and 5 years
Title
Visual Object and Space Perception (VOSP) Silhouettes
Description
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.
Time Frame
1, 2, and 5 years
Title
Clinical Dementia Rating Scale Global score and Sum of Boxes
Description
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.
Time Frame
1, 2, and 5 years
Title
The Lawton Instrumental Activities of Daily Living Scale (IADL)
Description
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.
Time Frame
1, 2, and 5 years
Title
6 minutes' walk test
Description
Change in 6 minutes' walk-test
Time Frame
1, 2, and 5 years
Title
Functional MRI
Description
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.
Time Frame
1, 2, and 5 years
Title
SF-36
Description
Quality of Life SF-36 Questionnaire. Computer-based scoring services for the SF-36v2 are available through QualityMetric™ or its licensed certified vendors.
Time Frame
1, 2, and 5 years
Title
Biomarker profile in blood
Description
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.
Time Frame
1, 2, and 5 years
Title
Biomarker profile in cerebrospinal fluid
Description
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.
Time Frame
1, 2, and 5 years
Title
Echocardiography - Cardiac dimensions - Left ventricular end diastolic diameter
Description
Changes in cardiac dimensions - left ventricular end diastolic diameter (mm).
Time Frame
1, 2, and 5 years
Title
Echocardiography - Cardiac dimensions - Right ventricular dimension
Description
Changes in cardiac dimensions - right ventricular dimension (mm).
Time Frame
1, 2, and 5 years
Title
Echocardiography - Cardiac volumes - Left ventricular and diastolic volume.
Description
Changes in cardiac volumes - left ventricular and diastolic volume (mL).
Time Frame
1, 2, and 5 years
Title
Echocardiography - Cardiac volumes - Right ventricular volume
Description
Changes in cardiac volumes. Right ventricular volume (mL).
Time Frame
1, 2, and 5 years
Title
Echocardiography - Functional indices - Ejection fraction
Description
Changes in functional indices - ejection fraction (%).
Time Frame
1, 2, and 5 years
Title
Echocardiography - Functional indices - Left ventricular strain
Description
Changes in functional indices - left ventricular strain (%).
Time Frame
1, 2, and 5 years
Title
Echocardiography - Functional indices - Ventricular velocity
Description
Changes in functional indices - ventricular velocity (cm/s).
Time Frame
1, 2, and 5 years
Title
Echocardiography - Functional indices - Right ventricular strain
Description
Changes in functional indices - right ventricular strain (%).
Time Frame
1, 2, and 5 years
Title
Echocardiography - Functional indices - Left ventricular stiffness
Description
Changes in functional indices - left ventricular stiffness.
Time Frame
1, 2, and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atefe R. Tari
Phone
+47 48079041
Email
atefe.r.tari@ntnu.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Wisløff, PhD, Prof
Organizational Affiliation
Cardiac Exercise Research Group at the Department of Circulation and Medical Imaging, NTNU
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sigrid Botne Sando, MD, PhD
Organizational Affiliation
Department of Neurology and Clinical Neurophysiology, St. Olavs University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology and Clinical Neurophysiology, St Olavs Hospital
City
Trondheim
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigrid Botne Sando, MD, PhD
Email
sigrid.b.sando@ntnu.no

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
To be decided
IPD Sharing Time Frame
After study completion
IPD Sharing Access Criteria
Collaborative research projects

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Safety and Efficacy of Plasma Transfusion From Exercise-trained Donors in Patients With Early Alzheimer's Disease

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