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Plasmapheresis Versus Plasma Infusion From Young APOE3 Homozygotes Into MCI APOE4 Homozygotes to Slow Disease Progression

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03887741
Collaborator
(none)
9
Enrollment
1
Location
3
Arms
14.5
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Plasmapheresis
  • Biological: Plasma infusion
 Phase 1

Study Design

Study Type:
Interventional
Anticipated 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.
Actual Study Start Date :
Sep 15, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Adverse events [One year]

    Number of adverse events reported

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Florida Jacksonville Florida United States 32224

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Neill R Graff-Radford, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Neill R. Graff-Radford, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03887741
Other Study ID Numbers:
  • 18-007034
First Posted:
Mar 25, 2019
Last Update Posted:
Oct 21, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Disease Progression
Cognitive Dysfunction

Study Results

No Results Posted as of Oct 21, 2021