NCT02256306

Brief Summary

The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 3, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

September 25, 2014

Last Update Submit

October 9, 2017

Conditions

Mild-To-Moderate Alzheimer's DiseaseAlzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability, and number of subjects who comply with the research protocol as a measure of feasibility.

    9 weeks

Secondary Outcomes (7)

  • Change on the 13-item ADAS-Cog

    9 weeks

  • Change on the Trail-Making Test

    9 weeks

  • Change on the Clinical Dementia Rating scale Sum of Boxes (CDR-SB)

    9 weeks

  • Change on the Functional Activities Questionnaire (FAQ)

    9 weeks

  • Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)

    9 weeks

  • +2 more secondary outcomes

Other Outcomes (4)

  • Change in functional connectivity in the default mode network as assessed by resting state functional MRI

    9 weeks

  • Compositional assessment of plasma using in vitro analytical methods. The goal is to assess plasma components that might be associated with aging and/or Alzheimer's disease

    9 weeks

  • In vivo assessment of plasma samples to determine their potential histological effects on the hippocampus and their potential behavioral effects in animal models of cognition

    9 weeks

  • +1 more other outcomes

Study Arms (1)

Young Donor Plasma

EXPERIMENTAL

Subjects will receive 1 unit of plasma, once weekly for 4 weeks.

Other: Plasma

Interventions

PlasmaOTHER

1 unit of Plasma From Young Donors (Male, aged 30 or younger)

Young Donor Plasma

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of probable Alzheimer's disease (NIA-AA criteria)
  • Mini-Mental State Examination (MMSE) score 12-24
  • Availability of a study partner who knows the patient well and is willing to accompany the subject to all trial visits, to participate in questionnaires and to complete daily journal assessments

You may not qualify if:

  • Pregnancy or unwilling to use adequate birth control method for duration of and 6 months beyond study participation
  • Positive 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
  • Related to medical history:
  • Stroke
  • Anaphylaxis
  • 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
  • IgA deficiency (by history)
  • Related to medications or other treatments:
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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: 30383097DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 25, 2014

First Posted

October 3, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

October 10, 2017

Record last verified: 2017-10

Locations

US(1)