We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Plasmapheresis for Treatment of Age-Related Frailty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05054894
Recruitment Status : Enrolling by invitation
First Posted : September 23, 2021
Last Update Posted : April 18, 2022
Sponsor:
Information provided by (Responsible Party):
Neurological Associates of West Los Angeles

Brief Summary:
This study is designed to evaluate the efficacy of albumin-infused plasmapheresis, using the Fresenius Kabi 'Amicus' apheresis machine, among patients with age-related frailty characterized by reduced physical, cognitive and immunological functioning. Additionally, this study is designed to evaluate the safety and tolerability of repeated plasmapheresis treatment.

Condition or disease Intervention/treatment Phase
Age-Related Frailty Other: Therapeutic Plasma Exchange (TPE) Early Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study for the Use of Plasmapheresis for Treatment of Age-Related Frailty
Actual Study Start Date : March 19, 2021
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : May 2025

Arm Intervention/treatment
Experimental: Experimental Group (Plasmapheresis for Age-Related Frailty)
Participants will receive plasmapheresis once a month for six months. All participants will be in this arm.
Other: Therapeutic Plasma Exchange (TPE)

Following all necessary screening and consenting protocol, patients will be scheduled for the plasmapheresis procedure.

Plasmapheresis

On the days of the scheduled procedure, patients will undergo up to 1.5 hours of plasmapheresis treatment. Patients will be awake and situated in a relaxed position in a reclined chair. The plasmapheresis device to be used is the Fresenius Kabi 'Amicus', which is currently FDA approved for a variety of clinical conditions. In one treatment, roughly 60-70% of a patient's plasma can safely be replaced; by using six consecutive treatments, more of the patient's plasma (approaching 100%) will be replaced in an exponential fashion.

Other Name: Plasmapheresis




Primary Outcome Measures :
  1. Change in Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale [ Time Frame: Change in Scale Score after completion of study (6 months) ]
    A global clinical measure of fitness and frailty in elderly people, ranging from 1-9, with 1 being 'Very Fit', and 9 being 'Terminally I'll'. Reduction in score from higher to lower is to be seen as improvement in frailty.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion: In order for a subject to be considered for the inclusion in this study, the following criteria are required:

  • Age eligibility requirements fall in a range from 50 to 95 years of age
  • Clinical appraisal by physician indicating signs of frailty (apart from a co-occurring condition), scoring 3<x <7 as denoted by the CSHA Clinical Frailty Scale (see Appendix A; Rockwood, Song, MacKnight, et al, 2005; Golpanian, DiFede, Pujol, et al., 2016)

Exclusion: In order for a subject to be considered for this study, he/she may NOT have any of the following

  • Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
  • Pregnancy, women who may become pregnant or are breastfeeding
  • Advanced terminal illness
  • Subjects with rash or open wounds (for example from treatment of squamous cell cancer)
  • Subjects with a reactive serologic test positive for Syphilis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05054894


Locations
Layout table for location information
United States, California
Neurological Associates - The Interventional Group
Santa Monica, California, United States, 90403
Sponsors and Collaborators
Neurological Associates of West Los Angeles
Investigators
Layout table for investigator information
Principal Investigator: Sheldon Jordan, M.D. Neurological Associates The Interventional Group
Layout table for additonal information
Responsible Party: Neurological Associates of West Los Angeles
ClinicalTrials.gov Identifier: NCT05054894    
Other Study ID Numbers: PlasmapheresisFrailty2021
First Posted: September 23, 2021    Key Record Dates
Last Update Posted: April 18, 2022
Last Verified: April 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Frailty
Pathologic Processes