Plasmapheresis for Treatment of Age-Related Frailty
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|ClinicalTrials.gov Identifier: NCT05054894|
Recruitment Status : Enrolling by invitation
First Posted : September 23, 2021
Last Update Posted : April 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Age-Related Frailty||Other: Therapeutic Plasma Exchange (TPE)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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.
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
|United States, California|
|Neurological Associates - The Interventional Group|
|Santa Monica, California, United States, 90403|
|Principal Investigator:||Sheldon Jordan, M.D.||Neurological Associates The Interventional Group|