Clinical trial NCT03713957: A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Parkinson's Disease
Dementia
Lead sponsor: Alkahest, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2018-10-22
Enrollment: 79
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of GRF6021, a plasma derived product, administered by intravenous (IV) infusion to subjects with Parkinson's disease (PD) and cognitive impairment. The study duration for the subjects will be approximately 7 months.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Approximately 24 Months
Secondary outcomes:
measure: The Montreal Cognitive Assessment (MoCA) Score.
timeFrame: Change from Baseline to Week 16
measure: 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.
timeFrame: Change from Baseline to Week 20
measure: The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency.
timeFrame: Change from Baseline to Week 20
measure: The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and Total Score.
timeFrame: Change from Baseline to Week 16
measure: The Schwab and England Activities of Daily Living (SE-ADL) Scale.
timeFrame: Change from Baseline to Week 24
measure: The Clinical Impression of Severity Index - PD (CISI-PD).
timeFrame: Change from Baseline to Week 24
measure: The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39).
timeFrame: Change from Baseline to Week 20
measure: The Geriatric Depression Scale-15 (GDS-15).
timeFrame: Change from Baseline to Week 20
measure: The Digital Clock Drawing Test (dCDT).
timeFrame: Change from Baseline to Week 20
measure: Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB.
timeFrame: Change from Baseline to Week 20
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Trials, Inc.
state: Arkansas
city: Englewood
country: United States
facility: Rocky Mountain Movement Disorders Center
state: Colorado
city: Doral
country: United States
facility: Moonshine Research Center
state: Florida
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: South Miami
country: United States
facility: Qps_Mra, Llc
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: NeuroTrials Research Inc.
state: Georgia
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Plymouth
country: United States
facility: SRI Biosciences
state: Michigan
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Raleigh
country: United States
facility: Wake Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Centex Studies, INC.
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Bron
country: France
facility: Hopital Neurologique
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Lille
country: France
facility: Hopital Roger Salengro
city: Marseille
country: France
facility: Hopital de la Timone
city: Nimes
country: France
facility: CHU Caremeau
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Toulouse
country: France
facility: CHU Purpan - Hopital Pierre Paul Riquet
Study officials:
affiliation: Alkahest, Inc.
name: Alkahest Medical Monitor
role: STUDY_DIRECTOR
References: