Plasmapheresis for Frailty

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Neurological Associates of West Los Angeles

Disqualifiers: Pregnancy, Terminal illness, Syphilis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sheldon Jordan, MD

Principal Investigator

Neurological Associates The Interventional Group

Eligibility Criteria

This trial is for people aged 50-95 showing signs of age-related frailty, which includes weakened physical, cognitive, and immune functions. Participants must score between 3 and 7 on the CSHA Clinical Frailty Scale. It's not open to pregnant or breastfeeding women, those with terminal illnesses, syphilis, inability to lay still for long periods, or with rashes/open wounds.

Inclusion Criteria

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)

I am between 50 and 95 years old.

Exclusion Criteria

I can't stay still enough to fall asleep in a calm environment.

I have a rash or open wounds, possibly from skin cancer treatment.

Subjects with a reactive serologic test positive for Syphilis

Treatment Details

Interventions

• Therapeutic Plasma Exchange (TPE)

Trial Overview The study tests how effective plasmapheresis (filtering blood plasma) is in treating age-related frailty using a machine called 'Amicus'. The process involves replacing a patient's plasma with albumin solution to see if it improves their condition.

Participant Groups

Group I: Experimental Group (Plasmapheresis for Age-Related Frailty) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Neurological Associates of West Los Angeles

Lead Sponsor

Trials

26

Recruited

4,000+