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Impact of Therapeutic Plasma Exchange on RNA Biomarker Expression Levels in Alzheimer's Patients

Impact of Therapeutic Plasma Exchange on RNA Biomarker Expression Levels in Alzheimer's Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06079827
Enrollment
43
Registered
2023-10-12
Start date
2022-03-22
Completion date
2025-09-01
Last updated
2023-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Brief summary

The study will determine if Therapeutic Plasma Exchange removes RNA biomarkers associated with Alzheimer's Disease and how quickly those biomarkers reappear after treatment.

Detailed description

Participants with a diagnosis of Alzheimer's or Mild Cognitive Impairment will undergo therapeutic plasma exchange as part of their treatment for the disease as per the AMBAR Trial protocol. Patients will undergo one non-invasive tests to assess their microvascular system and complete one online test to assess the degree of cognitive impairment. Patients will have their blood drawn pre-plasma exchange, immediately post plasma exchange and repeated assessments and blood draws at seven day intervals post plasma exchange ending on the twenty-eighth day after the plasma exchange. Their blood will be analyzed by FBB Biomed to identify the presence of unique RNA biomarkers associated with Alzheimer's disease and determine how quickly they regenerate.

Interventions

None listed

Sponsors

MaxWell Clinic, PLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

1. Subject is scheduled to undergo their first TPE Procedure for a diagnosis of Alzheimer's Disease or previous mental/cognitive impairment 2. Mentally capable of understanding and completing informed consent for the study.

Exclusion criteria

1. Subject is unable or failed to return/provide blood specimen on days seven (7), fourteen (14) , twenty-one (21), and twenty-eight (28) (plus or minus 1 day on follow up draws) post plasma exchange 2. Subject is unable to provide informed consent.

Design outcomes

Primary

MeasureTime frameDescription
To ascertain if Therapeutic Plasma Exchange (TPE) reduces the presence of RNA biomarkers in a small sample of Alzheimer's patients.28 daysMeasurement of RNA Biomarkers inside the participants blood stream

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026