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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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.

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Mild to Moderate Alzheimer Disease Drug: GRF6019 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 16, 2018
Actual Primary Completion Date : May 24, 2019
Actual Study Completion Date : May 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GRF6019 Low Dose
Subjects will receive a low dose of GRF6019 for 5 consecutive days at Week 1 and Week 13.
Drug: GRF6019
GRF6019 for IV infusion

Experimental: GRF6019 High Dose
Subjects will receive a high dose of GRF6019 for 5 consecutive days at Week 1 and Week 13.
Drug: GRF6019
GRF6019 for IV infusion




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The Mini-Mental State Examination (MMSE) [ Time Frame: Baseline to 6 months ]
    Changes in scores on the MMSE

  2. Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADASCog/11) [ Time Frame: Baseline to 6 months ]
    Changes in scores on the 11-item ADASCog/11

  3. The Grooved Pegboard Test [ Time Frame: Baseline to 6 months ]
    Changes in scores on the Grooved Pegboard Test

  4. The Category Fluency Test (CFT) [ Time Frame: Baseline to 6 months ]
    Changes in scores on the CFT

  5. The Clinical Dementia Rating Scale - Sum of Boxes (CDR-SOB) [ Time Frame: Baseline to 6 months ]
    Changes in the CDR-SOB

  6. The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline to 6 months ]
    Changes in the ADCS-ADL

  7. The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCSCGIC) [ Time Frame: Baseline to 6 months ]
    Changes on the ADCSCGIC

  8. The Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Baseline to 6 months ]
    Change on the NPI-Q

  9. The Savonix Neurocognitive Assessments and Digit Span [ Time Frame: Baseline to 6 months ]
    Change on the Savonix Neurocognitive Assessments and Digit Span



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520998


Locations
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United States, California
Synergy East
Lemon Grove, California, United States, 91945
CNS Network
Long Beach, California, United States, 90806
Pacific Research Network
San Diego, California, United States, 92103
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States, 33009
Miami Jewish Health Systems
Miami, Florida, United States, 33137
Behavioral Clinical Research
North Miami, Florida, United States, 33161
Bioclinica Research
Orlando, Florida, United States, 32806
United States, New Jersey
Princeton Medical Institute
Princeton, New Jersey, United States, 08540
United States, Texas
Serenity Inpatient
DeSoto, Texas, United States, 75115
United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Alkahest, Inc.
Investigators
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Study Director: Alkahest Medical Monitor Alkahest, Inc.

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Responsible Party: Alkahest, Inc.
ClinicalTrials.gov Identifier: NCT03520998     History of Changes
Other Study ID Numbers: ALK6019-201
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders