Plasmapheresis Versus Plasma Infusion from Young APOE3 Homozygotes Into MCI APOE4 Homozygotes to Slow Disease Progression
NCT ID: NCT03887741
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
3 participants
INTERVENTIONAL
2021-09-15
2024-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Plasmapheresis
3 patients will have monthly plasmapheresis for 6 months and followed for a total of 12 months
Plasmapheresis
Patient will have monthly plasma exchange with young ApoE 33 plasma. Each exchange will be 1.5 volume of patient's plasma
Plasma infusion
3 patients will have biweekly plasma infusion for 6 months and followed for 12 months
Plasma infusion
Infuse every two weeks with ApoE33 young plasma (1unit) for 6 months
Control group
3 patients will be followed for 12 months
No interventions assigned to this group
Interventions
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Plasmapheresis
Patient will have monthly plasma exchange with young ApoE 33 plasma. Each exchange will be 1.5 volume of patient's plasma
Plasma infusion
Infuse every two weeks with ApoE33 young plasma (1unit) for 6 months
Eligibility Criteria
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Inclusion Criteria
* APOE 44 homozygote.
* Meets the Petersen criteria for MCI (41).
* Clinical Dementia Rating (CDR) of 0.5 and Mini Mental Status Examination (MMSE) of 24 to 30 inclusive.
* Has an informant who the investigator judges has sufficient patient contact to provide accurate information.
* Stable depression and or anxiety.
* Stable psychoactive medication for 6 weeks.
Exclusion Criteria
* Patients who do not want to receive blood transfusion for religious or cultural reasons such as Jehovah Witness Faith.
* Has a medical condition that would interfere with participation such as congestive heart failure (New York Heart Association Class III or IV), unstable angina, moderate to severe renal impairment, liver failure, and poorly controlled diabetes.
* History of autoimmune disease considered clinically significant or requiring chronic steroid or immune suppression medication.
* History of being HIV +.
* History of +VE test result indicating active hepatitis C or B (defined as both hepatitis B surface antigen and hepatitis core antibody +VE).
* Uncontrolled hypertension as defined by systolic/diastolic BP three times more than 165/100.
* No venous access for plasma exchange therapy.
* Any neurological condition that could be contributing to cognitive decline such as Lewy body disease, front temporal dementia, strokes or other cerebrovascular disease, head trauma, substance abuse, multiple sclerosis, Vitamin B12 deficiency, thyroid deficiency.
* Epileptic seizures within 10 years of screening.
* Cancer diagnosis (other than non-melanoma skin cancer) in the last 5 years.
* More than 1 subcortical stroke or more than 1 cortical stroke.
* Unable to have an MRI.
* MRI showing acute or subacute hemorrhage, evidence of normal pressure hydrocephalus, hemispheric infarcts, glioma or other brain tumor that could contribute to cognitive decline.
* Unstable psychiatric condition.
* On another experimental treatment study or has been on one in the last 3 months.
* If a patient consents to lumbar puncture (LP), they will be excluded from LP if any contraindication to having an LP is present. Examples are platelet count\<100,000, spine deformity or contraindication to come off blood thinner for the LP. Patients may still participate in the rest of the study without having and LP.
* Any unspecified reason that the investigator finds the patient unsuitable to take part.
50 Years
75 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Neill R. Graff-Radford, M.D.
Principal Investigator
Principal Investigators
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Neill R Graff-Radford
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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18-007034
Identifier Type: -
Identifier Source: org_study_id