100 Participants Needed

Plasmapheresis for Frailty

Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Neurological Associates of West Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Dr. Sheldon Jordan | Neurologist | Los ...

Sheldon Jordan, MD

Principal Investigator

Neurological Associates The Interventional Group

Are You a Good Fit for This Trial?

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
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive plasmapheresis once a month for six months

6 months
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
Weekly follow-ups

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Experimental Group (Plasmapheresis for Age-Related Frailty)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Neurological Associates of West Los Angeles

Lead Sponsor

Trials
26
Recruited
4,000+
Unbiased ResultsWe believe in providing patients with all the options.
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