Impact of Therapeutic Plasma Exchange on RNA Biomarker Ex... | NCT06079827

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

NCT06079827

Sponsor

MaxWell Clinic, PLC

Status

Unknown status

Last Update Posted

Oct 12, 2023Actual

Enrollment

43Estimated

Phase

Not provided

Conditions

Alzheimer Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 22, 2022Actual

Primary Completion Date

Sep 1, 2024Estimated

Completion Date

Sep 1, 2025Estimated

First Submitted Date

Oct 6, 2023

First Submission Date that Met QC Criteria

Oct 11, 2023

First Posted Date

Oct 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2023

Last Update Posted Date

Oct 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

43Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To ascertain if Therapeutic Plasma Exchange (TPE) reduces the presence of RNA biomarkers in a small sample of Alzheimer's patients.	Measurement of RNA Biomarkers inside the participants blood stream	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Subject is unable to provide informed consent.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult individuals diagnosed with Alzheimer's Disease or mild cognitive impairment who will be undergoing plasma exchange per the AMBAR Trial protocol

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The MaxWell Clinic	Recruiting	Brentwood	Tennessee	37027	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Study results will be shared via publication to peer reviewed journals on Alzheimer's Disease and Cellular Medicine

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

2-3 Years of study completion. Enduring in journal publication.

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided