The Stanford Parkinson's Disease Plasma Study

NCT02968433 | Completed Phase 1 Results DMC

• 1 other identifier: IRB 38417
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate that young plasma infusions can be performed safely in patients with Parkinson's Disease (PD). Secondary outcomes will include behavioral and laboratory data that will support the next study that will inquire whether young plasma infusions improve or slow the progression of cognitive, mood and/or motor impairment and rate markers of the disease.

Conditions

Parkinson Disease(PD)

Keywords

Young Male Plasma

Outcome Measures

Primary Outcomes (1)

• Number of Related and Unrelated Adverse Events

  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.

  8 weeks

Other Outcomes (3)

• Change in Quantitative Data of Cognitive Ability (Neuropsychological Battery)

  8 weeks

• Change in Quality of Life

  8 weeks

• Change in Quantitative Data of Motor Movements up to 8 Weeks

  8 weeks

Study Arms (1)

Infusions of Young Plasma

EXPERIMENTAL

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

Interventions

Infusions of young plasma DRUG

Participants will receive four twice- weekly infusions of 1 unit young plasma (male, ages between 18-25)

Infusions of Young Plasma

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of clinically probable or established Parkinson's Disease (MDS criteria)
• Subject must be on a stable dose of dopaminergic medication and/or Deep Brain Stimulation (DBS) parameters for at least 4 weeks prior to screening and for the duration of the study
• Subject must be competent to sign consent
• Subject must be willing to commit to being available for testing and infusions for 6 consecutive weeks (2 testing consecutive weeks, 4 infusion consecutive weeks) followed by two visits a month after final infusion.
• The availability of a study partner who knows the patient well and is willing to accompany the subject to all trial (optional if participant is able to consent and travel by self)

You may not qualify if:

• The participation in any other interventional clinical trial
• The inability to travel to Stanford
• Inability to walk without assistance in the off or on medication state
• The clinically determined presence of dementia
• A clinical suspicion/diagnosis of Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Lewy Body Dementia (LBD), Essential Tremor (ET)
• Subject's pregnancy or likelihood of pregnancy within the next 6 months.
• Subject's positive test results for Hepatitis B, Hepatitis C or HIV at screening
• Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study
• Subject's medical history of:
• Stroke Anaphylaxis Gout- may cause an increase in uric acid Prior adverse reaction to any human blood product Any history of a blood coagulation disorder or hypercoagulability Congestive heart failure Uncontrolled hypertension Renal failure Prior intolerance to intravenous fluids Recent history of uncontrolled atrial fibrillation immunoglobulin A deficiency (by history)
• Subject's relation to medications or other treatments:
• Any concurrent use of an anticoagulant therapy. Antiplatelet drugs (e.g., aspirin or clopidogrel) are acceptable.
• The use of Inosine, which may alter urate levels
• Initiation or change in the dosage of a cholinesterase inhibitor or memantine during the trial. A participant already on a cholinesterase inhibitor or memantine must be on a stable dose for at least one month prior to Screening.
• Concurrent participation in another interventional treatment trial for Parkinson's disease. If there was prior participation, the last dose of the investigational agent must have been at least 6 months prior to Screening.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Movement Disorders Clinic

Stanford, California, 94304, United States

Location

Related Publications (4)

• Sha SJ, Deutsch GK, Tian L, Richardson K, Coburn M, Gaudioso JL, Marcal T, Solomon E, Boumis A, Bet A, Mennes M, van Oort E, Beckmann CF, Braithwaite SP, Jackson S, Nikolich K, Stephens D, Kerchner GA, Wyss-Coray T. Safety, Tolerability, and Feasibility of Young Plasma Infusion in the Plasma for Alzheimer Symptom Amelioration Study: A Randomized Clinical Trial. JAMA Neurol. 2019 Jan 1;76(1):35-40. doi: 10.1001/jamaneurol.2018.3288.

  PMID: 30383097 BACKGROUND

• Villeda SA, Luo J, Mosher KI, Zou B, Britschgi M, Bieri G, Stan TM, Fainberg N, Ding Z, Eggel A, Lucin KM, Czirr E, Park JS, Couillard-Despres S, Aigner L, Li G, Peskind ER, Kaye JA, Quinn JF, Galasko DR, Xie XS, Rando TA, Wyss-Coray T. The ageing systemic milieu negatively regulates neurogenesis and cognitive function. Nature. 2011 Aug 31;477(7362):90-4. doi: 10.1038/nature10357.

  PMID: 21886162 BACKGROUND

• Villeda SA, Plambeck KE, Middeldorp J, Castellano JM, Mosher KI, Luo J, Smith LK, Bieri G, Lin K, Berdnik D, Wabl R, Udeochu J, Wheatley EG, Zou B, Simmons DA, Xie XS, Longo FM, Wyss-Coray T. Young blood reverses age-related impairments in cognitive function and synaptic plasticity in mice. Nat Med. 2014 Jun;20(6):659-63. doi: 10.1038/nm.3569. Epub 2014 May 4.

  PMID: 24793238 BACKGROUND

• Parker JE, Martinez A, Deutsch GK, Prabhakar V, Lising M, Kapphahn KI, Anidi CM, Neuville R, Coburn M, Shah N, Bronte-Stewart HM. Safety of Plasma Infusions in Parkinson's Disease. Mov Disord. 2020 Nov;35(11):1905-1913. doi: 10.1002/mds.28198. Epub 2020 Jul 7.

  PMID: 32633860 RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Helen Bronte-Stewart
• Organization: Stanford University

hbsmovlab@gmail.com

650-723-6709

Study Officials

• Helen Bronte-Stewart, MS, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 18, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 30, 2020
• Results First Posted: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)