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A Randomized Study to Assess the Safety of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03520998
Recruitment Status : Completed
First Posted : May 10, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Alkahest, Inc.

Tracking Information
First Submitted Date  ICMJE April 25, 2018
First Posted Date  ICMJE May 10, 2018
Last Update Posted Date July 16, 2019
Actual Study Start Date  ICMJE April 16, 2018
Actual Primary Completion Date May 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
Incidence of treatment-emergent adverse events (safety) [ Time Frame: Baseline to 6 months ]
Treatment-emergent adverse events identified by MedDRA preferred term and grouped by MedDRA System Organ Class
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03520998 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
  • The Mini-Mental State Examination (MMSE) [ Time Frame: Baseline to 6 months ]
    Changes in scores on the MMSE
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADASCog/11) [ Time Frame: Baseline to 6 months ]
    Changes in scores on the 11-item ADASCog/11
  • The Grooved Pegboard Test [ Time Frame: Baseline to 6 months ]
    Changes in scores on the Grooved Pegboard Test
  • The Category Fluency Test (CFT) [ Time Frame: Baseline to 6 months ]
    Changes in scores on the CFT
  • The Clinical Dementia Rating Scale - Sum of Boxes (CDR-SOB) [ Time Frame: Baseline to 6 months ]
    Changes in the CDR-SOB
  • The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline to 6 months ]
    Changes in the ADCS-ADL
  • The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCSCGIC) [ Time Frame: Baseline to 6 months ]
    Changes on the ADCSCGIC
  • The Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Baseline to 6 months ]
    Change on the NPI-Q
  • The Savonix Neurocognitive Assessments and Digit Span [ Time Frame: Baseline to 6 months ]
    Change on the Savonix Neurocognitive Assessments and Digit Span
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Study to Assess the Safety of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE A Prospective, Randomized, Double-Blind, Dose-Comparison Concurrent Control Study to Assess the Safety and Tolerability of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease
Brief Summary This study is evaluating the safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with mild to moderate Alzheimer's disease.
Detailed Description

This is a randomized, double-blind, dose-comparison concurrent control study to assess the safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered by intravenous (IV) infusion to subjects with mild to moderate Alzheimer's disease.

Subjects will be randomized 1:1 to a low dose or a high dose of active treatment in a double-blind manner. All subjects will receive one infusion per day at the randomized dose for 5 consecutive days during Week 1 and, again, during Week 13 (for a total of 10 doses per subject). All IV infusions will take place at an inpatient research unit while the follow-up visits after each treatment period will be on an outpatient basis. Subjects will participate for a total of 6 months in this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer Disease
  • Mild to Moderate Alzheimer Disease
Intervention  ICMJE Drug: GRF6019
GRF6019 for IV infusion
Study Arms  ICMJE
  • Experimental: GRF6019 Low Dose
    Subjects will receive a low dose of GRF6019 for 5 consecutive days at Week 1 and Week 13.
    Intervention: Drug: GRF6019
  • Experimental: GRF6019 High Dose
    Subjects will receive a high dose of GRF6019 for 5 consecutive days at Week 1 and Week 13.
    Intervention: Drug: GRF6019
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 24, 2019
Actual Primary Completion Date May 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of probable AD based upon the National Institute on Aging-Alzheimer's Association (NIA-AA) Criteria
  • MMSE Score 12-24 inclusive
  • Modified Hachinski Ischemia Scale (MHIS) score of ≤ 4
  • Provided a signed and dated informed consent form (either the subject and/or subject's legal representative as well as the trial partner)

Exclusion Criteria:

  • Evidence of clinically relevant neurological disorder(s) other than probable AD
  • History of blood coagulation disorders or hypercoagulability; any concurrent use of an anticoagulant therapy. (e.g., heparin, warfarin, thrombin inhibitors, Factor Xa inhibitors). Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.
  • Initiation or change in the dosage of cholinesterase inhibitors (AChEI), memantine, Axona, vitamin E supplementation or selegiline within 3 months prior to screening.
  • Heart disease (or history thereof), as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure (New York Association Class II, III or IV) in the 6 months prior to dosing; uncontrolled high blood pressure (systolic blood pressure of 160 mmHg or higher and/or diastolic blood
  • Prior hypersensitivity reaction to any human blood product or intravenous infusion; any known clinically significant drug allergy.
  • Treatment with any human blood product, including transfusions and intravenous immunoglobulin, during the 6 months prior to screening.
  • History of immunoglobulin A (IgA), haptoglobulin or C1 inhibitor deficiency; stroke, anaphylaxis, or thromboembolic complications of intravenous immunoglobulins.
  • Hemoglobin <10 g/dL in women; and <11 g/dL in men.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03520998
Other Study ID Numbers  ICMJE ALK6019-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alkahest, Inc.
Study Sponsor  ICMJE Alkahest, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alkahest Medical Monitor Alkahest, Inc.
PRS Account Alkahest, Inc.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP