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| Name | Class |
|---|---|
| Carolina Longevity Institute | UNKNOWN |
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This study will do a preliminary evaluation of a possible treatment for mild-to-moderate Parkinson's disease. Patients will be treated with either transfusions of plasma from young donors. or with placebo transfusions. In the following several months, Parkinson's symptoms will be monitored and compared for the two groups.
This is a double-blind placebo controlled trial, designed to evaluate the efficacy of plasma from volunteer donors of ages 18-25. This young fresh frozen plasma (yFFP) will be given intravenously in two doses of 12.5 ml/kg each, with 40-56 hours between doses. In the following 24 weeks, Parkinson's symptoms will be monitored using the short version of the Stanford Presenteeism Scale (SPS-6), and a modified version of the UPDRS scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young Fresh Frozen Plasma (yFFP) | Active Comparator | [21CFR640.30] Plasma from 18 - 25 year old volunteer donors |
|
| Saline | Placebo Comparator | 0.1% riboflavin in normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [21CFR640.30] Plasma from 18 - 25 year old volunteer donors | Biological | 12.5 ml/kg intravenous Spectrum Plasma yFFP, per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Physician assessment | Unified Parkinson Disease Rating Scale (UPDRS) | Two weeks prior to infusion, at one-three-six months post-infusion |
| Patient assessment | Changes in Stanford Presenteeism Scale (SPS) | Two weeks prior to infusion, at one-three-six months post-infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Stability of administration | Adverse events (if any) | At the time of infusions, day 1 and day 2 |
| Factors predicting a beneficial response | Patient Global Impression of change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dian Ginsberg, M.D. | The Ginstitute of Functional Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Neurology Center | Houston | Texas | 77030 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2021 | Oct 20, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2020 | Dec 1, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Placebo controlled trial
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Blinding will be achieved by preparing both yFFP and placebo (0.1% riboflavin in normal saline) solution into identical-sized, masked bags. The riboflavin is added to the saline to achieve indistinguishable color when compared to the yFFP. Physicians who evaluate patients are masked from treatment assignment.
|
| Saline | Other | 12.5 ml/kg intravenous 0.9% sodium chloride with 0.1% riboflavin , per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment. |
|
|
| After the last participant's final contact at 6 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D017670 |
| Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |