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 : Active, not recruiting
First Posted : November 18, 2016
Last Update Posted : April 4, 2019
|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 study that is ongoing at Stanford, in the department of Neurology and Neurological Sciences, is testing whether infusions of young plasma can ameliorate the cognitive impairment in patients with Alzheimer's disease (ClinicalTrials.gov identifier NCT02256306). To date, this has been well-tolerated by the participants, without major adverse effects.
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 :||15 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|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated 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 participants with treatment-related adverse events as assesses by CTCAE v4.0 [ Time Frame: 8 weeks ]The primary outcome measure is the number of participants with any adverse effects that might be related to young plasma infusions as a novel treatment to Parkinson's Disease symptoms.
- Baseline of quantitative data of motor movements [ Time Frame: 1 weeks ]The second outcome measure is the quantitative data of current motor movement ability.
- Change in quantitative data of motor movements from baseline [ Time Frame: 7 weeks ]The second outcome measure is the change in the quantitative data of current motor movement ability.
- 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.
- Baseline of quantitative data of cognitive ability [ Time Frame: 2 weeks ]The third outcome measure is quantitative data of current cognitive ability.
- Change in quantitative data of cognitive ability [ Time Frame: 7 weeks ]The third outcome measure is the change in quantitative data of current cognitive ability.
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|