Early Alzheimer's disease
Conditions
Interventions
Product Name: Exercised Plasma
Product Code: ExPlas
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Albumin
CAS Number: 70024-90-7
Current Sponsor code: ExPlas
Other descriptive name:
Sponsors
Norwegian University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Signed informed consent ? Age 50-75 years ? Diagnosis AD in early phase according to the IWG-2 criteria (42) ? In-vivo evidence of Alzheimer´s pathology (one of the following): o Decreased Aß42 together with increased t-tau or p-tau in CSF ? Increased tracer retention on amyloid PET ? Mini-Mental State Examination (MMSE) Score =20 ? 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 patient’s functional level ? The patient is judged fit for the study and capable to cooperate in treatment and follow-up. ? Ability to communicate in Norwegian or another Scandinavian language Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following 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 109/L) ? Contraindication for Octaplasma Related to medications or other treatments: ? Any concurrent use of anticoagulant therapy, clopidogrel or acetylsalicylic acid/dipyridamole 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 are 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 incompatible with MRI Certain metallic implants like joint prostheses 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to explore the safety of transfusion of plasma from exercise trained donors (ExPlas) compared to Octaplasma®, a commercially available virus inactivated plasma product pooled from approximately 1000 donors, and Sodium Chloride 0.9% (saline) in patients in the early symptomatic phase of AD and provide pilot data regarding efficacy. An additional aim is to provide advancements to the field by exploring therapeutical effects on AD of blood-borne factors. Primary endpoint of ExPlas Proportion of patients with adverse events after 1 year as a measure of safety and tolerability, and number of subjects who comply with the research protocol as a measure of feasibility. ;Secondary Objective: Secondary endpoints of ExPlas after 1, 2 and 5 years ?Change in performance in the CERAD (The Consortium to Establish a Registry for Alzheimer’s Disease) Ten word Test ?Change in the Mini-Mental State Examination Score ?Change in performance in Trail-Making test A and B ?Change in scores in other cognitive tests: the Clock Drawing Test, Controlled Oral Word Association Test (COWAT)-FAS, Visual Object and Space Perception (VOSP) Silhouettes ?Change in Clinical Dementia Rating Scale Global score and Sum of Boxes, and The Lawton Instrumental Activities of Daily Living Scale (IADL) ?Change in performance in the 6-minutes walk-test ?Change in/Reduced hippocampal atrophy and preservation of functional connectivity assessed by resting state functional MRI ?Change in score of quality-of-Life SF-36 Questionnaire ?Change in biomarkers in blood and cerebrospinal fluid ?Change in cardiac dimensions, volumes and functional indices ;Primary end point(s): Number of patiens with adverse events as a measure of safety and tolerability;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1, 2 and 5 years;Secondary end point(s): - Number of subjects who comply with the research protocol as a measure of feasibility • Change on the Mini-Mental State Examination Score • Change on the Trail-Making test A and B • Change on the Clock Drawing Test, COWAT FAS, VOSP, Ten Word Test • Change on Gait test (GAITRite) • Change on functional connectivity assessed by resting state functional MRI • Change in quality of Life SF-36 Questionnaire • Analysis of biomarkers in blood and cerebrospinal fluid | — |
Countries
Norway
Contacts
Public ContactNTNU
Norwegian University of Science and Technology, NTNU
Outcome results
None listed