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Plasma Infusion
Plasmapheresis vs Plasma Infusion for Mild Cognitive Impairment
Phase 1
Waitlist Available
Led By Neill R Graff-Radford
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stable psychoactive medication for 6 weeks
Stable depression and or anxiety
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study Summary
This trial will determine whether plasma infusion or exchange is safe for APOE 44 patients.
Who is the study for?
This trial is for people aged 50-75 with mild cognitive impairment (MCI) who are APOE4 homozygotes, have stable mental health medication use, and no recent participation in other experimental studies. Excluded are those with significant autoimmune diseases, HIV+, recent cancer history, uncontrolled hypertension, certain MRI findings or severe reactions to plasma products.Check my eligibility
What is being tested?
The study tests the safety of two procedures in slowing down cognitive decline: plasmapheresis (removing and treating blood plasma) versus infusing plasma from young donors without the APOE4 gene variant into older patients who do have it.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to infused plasma such as anaphylaxis or TRALI (lung injury), complications from plasmapheresis like low calcium levels or bleeding due to anticoagulants used during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My mental health medication has not changed in the last 6 weeks.
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My depression or anxiety is under control.
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I am between 50 and 75 years old.
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I have two copies of the APOE4 gene.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: PlasmapheresisExperimental Treatment1 Intervention
3 patients will have monthly plasmapheresis for 6 months and followed for a total of 12 months
Group II: Plasma infusionExperimental Treatment1 Intervention
3 patients will have biweekly plasma infusion for 6 months and followed for 12 months
Group III: Control groupActive Control1 Intervention
3 patients will be followed for 12 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plasmapheresis
2016
Completed Phase 3
~390
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,074 Total Patients Enrolled
Neill R Graff-RadfordPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to a lumbar puncture unless I have low platelets, spine issues, or can't stop blood thinners.My mental health medication has not changed in the last 6 weeks.My depression or anxiety is under control.I refuse blood transfusions due to my religious or cultural beliefs.I do not have any brain conditions like strokes, MS, or vitamin deficiencies affecting my thinking.You have had a serious allergic reaction to plasma or plasma-based products in the past.I am HIV positive.I am between 50 and 75 years old.I have two copies of the APOE4 gene.I have had multiple strokes in the deeper or outer parts of my brain.I do not have severe heart, kidney, liver problems, or uncontrolled diabetes.You have a mental health condition that is not currently stable.I have an autoimmune disease that needs ongoing medication.I have not had an epileptic seizure in the last 10 years.I was diagnosed with cancer, other than non-melanoma skin cancer, in the last 5 years.My MRI shows conditions like bleeding or tumors that could affect my brain function.
Research Study Groups:
This trial has the following groups:- Group 1: Plasmapheresis
- Group 2: Plasma infusion
- Group 3: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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