Effects of Plasma Exchange on RNA Biomarkers in Alzheimer's Patients
Impact of Therapeutic Plasma Exchange on RNA Biomarker Expression Levels in Alzheimer's Patients
This study is testing if a treatment called Therapeutic Plasma Exchange can help reduce certain RNA markers in people with Alzheimer's or Mild Cognitive Impairment and how quickly these markers come back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MaxWell Clinic, PLC Industry-sponsored |
| Locations | 1 site (Brentwood, Tennessee) |
| Trial ID | NCT06079827 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of Therapeutic Plasma Exchange (TPE) on RNA biomarkers in patients diagnosed with Alzheimer's Disease or Mild Cognitive Impairment. Participants will undergo TPE as part of their treatment, with blood samples collected before, immediately after, and at intervals up to 28 days post-treatment to analyze RNA biomarker levels. The study aims to determine if TPE effectively removes these biomarkers and how quickly they regenerate. Non-invasive tests will also be conducted to assess cognitive impairment and microvascular health.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Alzheimer's Disease or Mild Cognitive Impairment who are scheduled for their first Therapeutic Plasma Exchange procedure.
Not a fit: Patients who are unable to provide blood samples at the required intervals or cannot give informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of Alzheimer's Disease through biomarker monitoring.
How similar studies have performed: While the approach of using plasma exchange in Alzheimer's research is emerging, this specific investigation into RNA biomarkers is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brentwood, Tennessee
- The MaxWell Clinic — Brentwood, Tennessee, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.