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

Sponsor
MaxWell Clinic, PLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06079827
Collaborator
(none)
43
Enrollment
1
Location
41.4
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    43 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Therapeutic Plasma Exchange on RNA Biomarker Expression Levels in Alzheimer's Patients
    Actual Study Start Date :
    Mar 22, 2022
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. To ascertain if Therapeutic Plasma Exchange (TPE) reduces the presence of RNA biomarkers in a small sample of Alzheimer's patients. [28 days]

      Measurement of RNA Biomarkers inside the participants blood stream

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The MaxWell Clinic Brentwood Tennessee United States 37027

    Sponsors and Collaborators

    • MaxWell Clinic, PLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MaxWell Clinic, PLC
    ClinicalTrials.gov Identifier:
    NCT06079827
    Other Study ID Numbers:
    • FBB-PE-003
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Oct 12, 2023