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Trial record 1 of 1 for:    03887741
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Plasmapheresis Versus Plasma Infusion From Young APOE3 Homozygotes Into MCI APOE4 Homozygotes to Slow Disease Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887741
Recruitment Status : Enrolling by invitation
First Posted : March 25, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Neill R. Graff-Radford, M.D., Mayo Clinic

Brief Summary:
Determine safety of plasma infusion or exchange in APOE 44 patients.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Biological: Plasmapheresis Biological: Plasma infusion Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Plasmapheresis
3 patients will have monthly plasmapheresis for 6 months and followed for a total of 12 months
Biological: Plasmapheresis
Patient will have monthly plasma exchange with young ApoE 33 plasma. Each exchange will be 1.5 volume of patient's plasma

Experimental: Plasma infusion
3 patients will have biweekly plasma infusion for 6 months and followed for 12 months
Biological: Plasma infusion
Infuse every two weeks with ApoE33 young plasma (1unit) for 6 months

No Intervention: Control group
3 patients will be followed for 12 months



Primary Outcome Measures :
  1. Adverse events [ Time Frame: One year ]
    Number of adverse events reported



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Patient age 50 to 75.
  • 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

  • History of severe reaction to plasma or plasma derived products which include but not limited to severe allergic reaction, anaphylactic reaction and transfusion related acute lung injury (TRALI).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887741


Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Neill R Graff-Radford Mayo Clinic
Additional Information:
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Responsible Party: Neill R. Graff-Radford, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03887741    
Other Study ID Numbers: 18-007034
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Progression
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes