Plasmapheresis for Treatment of Age-Related Frailty

NCT05054894 | Unknown Early Phase 1

• 1 other identifier: PlasmapheresisFrailty2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Frailty

Outcome Measures

Primary Outcomes (1)

• Change in Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale

  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.

  Change in Scale Score after completion of study (6 months)

Study Arms (1)

Experimental Group (Plasmapheresis for Age-Related Frailty)

EXPERIMENTAL

Participants will receive plasmapheresis once a month for six months. All participants will be in this arm.

Other: Therapeutic Plasma Exchange (TPE)

Interventions

Therapeutic Plasma Exchange (TPE) OTHER

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.

Also known as: Plasmapheresis

Experimental Group (Plasmapheresis for Age-Related Frailty)

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurological Associates of West Los Angeles: lead

Study Sites (1)

Neurological Associates - The Interventional Group

Santa Monica, California, 90403, United States

Location

MeSH Terms

Interventions

Plasma Exchange; Plasmapheresis

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Sheldon Jordan, M.D.

  Neurological Associates The Interventional Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 23, 2021
• Study Start: March 19, 2021
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

US (1)