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

NCT03887741 | Completed Phase 1 FDA Drug

• 1 other identifier: 18-007034
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Number of adverse events reported

  One year

Study Arms (3)

Plasmapheresis

EXPERIMENTAL

3 patients will have monthly plasmapheresis for 6 months and followed for a total of 12 months

Biological: Plasmapheresis

Plasma infusion

EXPERIMENTAL

3 patients will have biweekly plasma infusion for 6 months and followed for 12 months

Biological: Plasma infusion

Control group

NO INTERVENTION

3 patients will be followed for 12 months

Interventions

Plasmapheresis BIOLOGICAL

Patient will have monthly plasma exchange with young ApoE 33 plasma. Each exchange will be 1.5 volume of patient's plasma

Plasmapheresis

Plasma infusion BIOLOGICAL

Infuse every two weeks with ApoE33 young plasma (1unit) for 6 months

Plasma infusion

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Neill R Graff-Radford

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 25, 2019
• Study Start: September 15, 2021
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)