NCT03713957

Brief Summary

This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for phase_2 parkinson-disease

Timeline
Completed

Started Nov 2018

Geographic Reach
3 countries

29 active sites

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

First Submitted

Initial submission to the registry

October 18, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

November 12, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 9, 2022

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

October 18, 2018

Results QC Date

December 8, 2021

Last Update Submit

May 5, 2022

Conditions

Parkinson Disease

Keywords

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersParkinson's DiseaseDementia

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class

    Approximately 24 Months

Secondary Outcomes (10)

  • The Montreal Cognitive Assessment (MoCA) Score.

    Change from Baseline to Week 16

  • Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB.

    Change from Baseline to Week 20

  • The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency.

    Change from Baseline to Week 20

  • The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and Total Score.

    Change from Baseline to Week 16

  • The Schwab and England Activities of Daily Living (SE-ADL) Scale.

    Change from Baseline to Week 24

  • +5 more secondary outcomes

Study Arms (2)

GRF6021

EXPERIMENTAL

Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.

Drug: GRF6021

Placebo

PLACEBO COMPARATOR

Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.

Other: Placebo

Interventions

GRF6021DRUG

GRF6021 for IV infusion

GRF6021
PlaceboOTHER

Placebo for IV infusion

Placebo

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Parkinson's Disease (PD), with at least 1 year of PD symptoms.
  • Diagnosis of PD with mild cognitive impairment (PD-MCI) or probable or possible Parkinson's disease dementia according to Movement Disorder Society's Clinical Diagnostic criteria.
  • Score on the Montreal Cognitive Assessment (MoCA) of 13-25.
  • Modified Hoehn and Yahr Stages 1-4.
  • Modified Hachinski Ischemic Scale (MHIS) score of 4 or less.

You may not qualify if:

  • History of blood coagulation disorders or hypercoagulability.
  • Current use of anticoagulant therapy. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.
  • Prior hypersensitivity reaction to any human blood product or any IV infusion.
  • Treatment with any human blood product, including transfusions and IV immunoglobulin, during the 6 months prior to screening.
  • History of immunoglobulin A or haptoglobin deficiency; stroke, anaphylaxis, or thromboembolic complications of IV immunoglobulins.
  • Heart disease, as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure in the 6 months prior to dosing
  • Hemoglobin \< 10 g/dL in women and \< 11 g/dL in men.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

Location

Rocky Mountain Movement Disorders Center

Englewood, Colorado, 80113, United States

Location

Moonshine Research Center

Doral, Florida, 33166, United States

Location

Riverside Clinical Research

Edgewater, Florida, 32132, United States

Location

MD Clinical

Hallandale, Florida, 33009, United States

Location

Research Centers of America, LLC

Hollywood, Florida, 33024, United States

Location

Suncoast Research Group, LLC

Miami, Florida, 33135, United States

Location

Qps_Mra, Llc

South Miami, Florida, 33143, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

NeuroTrials Research Inc.

Atlanta, Georgia, 30342, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

SRI Biosciences

Plymouth, Michigan, 48170, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

Wake Research

Raleigh, North Carolina, 27612, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Centex Studies, INC.

Houston, Texas, 77058, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Hopital Neurologique

Bron, 69677, France

Location

Hopital Henri Mondor

Créteil, 94000, France

Location

CHU Grenoble Alpes

Grenoble, 38043, France

Location

Hopital Roger Salengro

Lille, 59000, France

Location

Hopital de la Timone

Marseille, 13385, France

Location

CHU Caremeau

Nîmes, 30029, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CHU Charles Nicolle

Rouen, 76000, France

Location

CHU Purpan - Hopital Pierre Paul Riquet

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Parkinson DiseaseBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersDementia

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Results Point of Contact

Title
Head of Communications
Organization
Alkahest, Inc.
info@alkahest.com
(650) 801-0474

Study Officials

  • Alkahest Medical Monitor

    Alkahest, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2018

First Posted

October 22, 2018

Study Start

November 12, 2018

Primary Completion

July 20, 2020

Study Completion

July 20, 2020

Last Updated

May 9, 2022

Results First Posted

May 9, 2022

Record last verified: 2022-05

Locations

AU(1)US(19)FR(9)