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

NCT ID: NCT06079827

Last Updated: 2023-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-22

Study Completion Date

2025-09-01

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MaxWell Clinic, PLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The MaxWell Clinic

Brentwood, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Justin Davis

Role: primary

615-370-0091

Cale T Queen, PhD

Role: backup

16153700091

Other Identifiers

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FBB-PE-003

Identifier Type: -

Identifier Source: org_study_id

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