The Stanford Parkinson's Disease Plasma Study (SPDP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02968433|
Recruitment Status : Completed
First Posted : November 18, 2016
Results First Posted : December 30, 2020
Last Update Posted : December 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease(PD)||Drug: Infusions of young plasma||Phase 1|
Parkinson's disease (PD) is a neurodegenerative disease that affects over 1.6 million people in the United States and whose incidence increases with age, affecting over 1% of people over the age of 65. The neuropathological processes involved in PD are widespread throughout the brain, and are reflected in a constellation of motor, cognitive, mood and other non-motor symptoms. Treatments to date have largely focused on dopamine replacement strategies or deep brain stimulation, both symptomatic treatments.
As neurodegenerative diseases progress, there are major changes throughout the body and brain. These changes are transmitted in the body via the circulatory system between organs, tissues and cells. Recent findings from multiple laboratories have shown that infusions of young plasma into aging rodents can have beneficial effects on cognitive functions. This suggests that the circulating components of plasma can improve cognitive and disease-relevant symptoms. This has motivated the field to treat multiple disorders with blood products and their constituent active components.
The established safety of blood transfusions allows the investigators to test whether infusions of young plasma can ease the neurological symptoms in human subjects with neurodegenerative diseases. A related study of plasma infusions has already been completed at Stanford in patients with Alzheimer's disease (ClinicalTrials.gov identifier NCT02256306).
The investigator proposes to test the safety and efficacy of transfusing young plasma into PD participants, in order to establish its effects on motor and cognitive functions in participants in a Phase 1 study. The successful completion of this study will inform the design of future, larger and multicenter studies with the goal to determine whether infusions of young plasma can ameliorate the neurodegenerative symptoms and underlying pathophysiology in Parkinson's disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Stanford Parkinson's Disease Plasma (SPDP) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Moderate Parkinson's Disease|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||December 2019|
|Actual Study Completion Date :||December 2019|
Experimental: Infusions of Young Plasma
All participants will undergo neuropsychological, neuropsychiatric, and kinematic assessments prior to receiving infusions of young plasma as the treatment.
Participants will receive 1 unit of young plasma, twice a week over a four week duration.
After the four weeks of plasma infusions, participants will undergo neuropsychological, neuropsychiatric and kinematic reassessments. No deception will be used.
Drug: Infusions of young plasma
Participants will receive four twice- weekly infusions of 1 unit young plasma (male, ages between 18-25)
- Number of Related and Unrelated Adverse Events [ Time Frame: 8 weeks ]The primary outcome measure is the number of adverse events across all participants that might be related to young plasma infusions as a novel treatment to Parkinson's Disease symptoms. Adverse events were categorized as probably, possibly, or not related to the study intervention.
- Change in Quantitative Data of Cognitive Ability (Neuropsychological Battery) [ Time Frame: 8 weeks ]
Change in quantitative data of cognitive ability. Raw scores and normative scores were calculated for all measures according to standardized procedures across all 3 time points.
The cognitive test battery included:
- Trail Making Test Part A (0-92; lower scores indicate better performance) and B (0-300; lower scores indicate better performance)
- Digit Symbol Modalities Test (Oral: 0-110 and Written: 0-110; higher scores indicate better performance)
- Animal Naming Test (0-no maximum; higher scores indicate better performance)
- Controlled Oral Word Association Test (COWAT) (0-no maximum; higher score indicates better performance)
- CogStateTM Groton Maze Learning Test (GML) (minimum score is 0; lower scores indicate better performance)
- Wechsler Abbreviated Scale of Intelligence-II (WASI-II) Block Design (0-71; higher scores indicate better performance) and Matrix Reasoning (0-30; higher scores indicate better performance)
- Change in Quality of Life [ Time Frame: 8 weeks ]Quality of life (QOL) changes were tracked using the self-report Parkinson's Disease Questionnaire-39 (PDQ-39). The PDQ-39 includes 8 sub-scales: Mobility (raw score range 0-40), Activities of Daily Living (raw score range 0-24), Emotional Well-Being (raw score range 0-24), Stigma (raw score range 0-16), Social Support (raw score range 0-12), Cognition (raw score range 0-16), Communication (raw score range 0-12), and Bodily Discomfort (raw score range 0-12). Subscales scores are totaled then converted to a percentage to calculate the Total score (0 to 100, higher scores indicating the more problems). Ratings are based on participant experiences over the course of the prior month. Lower scores represent better quality of life for all scores.
- Change in Quantitative Data of Motor Movements up to 8 Weeks [ Time Frame: 8 weeks ]
The second outcome measure is the change in the quantitative data of current motor movement ability.
Patients completed a repetitive Wrist Flexion Extension (rWFE) task with both hands, off therapy at the baseline, immediate-post, and delayed-post visits. Patients were instructed to flex and extend their hands at the wrist as quickly as possible after a "Go" command was given and to stop when instructed. This movement was self-paced, lasted 30 seconds, and was measured using wearable sensors attached to the dorsum of each hand (Motus Bioengineering, Inc.). Variables of interest included the mean angular velocity (Vrms), the variability of mean angular velocity, (CV Vrms), and rhythmicity, defined as the regularity of the interstrike interval (CV ISI). MA = more affected; LA = less affected.
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): NCT02968433
|United States, California|
|Stanford Movement Disorders Clinic|
|Stanford, California, United States, 94304|
|Principal Investigator:||Helen Bronte-Stewart, MS, MD||Stanford University|