NCT06079827

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

2.4 years

First QC Date

October 6, 2023

Last Update Submit

October 11, 2023

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The MaxWell Clinic

Brentwood, Tennessee, 37027, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens will be biobanked for potential follow up studies.

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2023

First Posted

October 12, 2023

Study Start

March 22, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2025

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
2-3 Years of study completion. Enduring in journal publication.

Locations

US(1)