NCT03887741CompletedPhase 1
Plasmapheresis Versus Plasma Infusion from Young APOE3 Homozygotes Into MCI APOE4 Homozygotes to Slow Disease Progression: an Unblinded Phase 1 Safety, Methodological and Exploratory Biomarkers Study.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Adverse events
Study Overview
Brief Summary
Determine safety of plasma infusion or exchange in APOE 44 patients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Plasmapheresis
Experimental
3 patients will have monthly plasmapheresis for 6 months and followed for a total of 12 months
Intervention: Plasmapheresis (Biological)
Plasma infusion
Experimental
3 patients will have biweekly plasma infusion for 6 months and followed for 12 months
Intervention: Plasma infusion (Biological)
Outcomes
Primary Outcomes
Adverse events
Time Frame: One year
Number of adverse events reported
Secondary Outcomes
No secondary outcomes reported
Investigators
Neill R. Graff-Radford, M.D.
Principal Investigator
Mayo Clinic
Study Sites (1)
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