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

Completed · Phase 2

Conditions studied: Alzheimer Disease, Mild to Moderate Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT03520998

Run by

Alkahest, Inc.

People needed

47

Starts

2018-04-16

Expected to finish

2019-05-24

Last updated by the study team

2021-01-29

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Synergy East — Lemon Grove, California, United States
• CNS Network — Long Beach, California, United States
• Pacific Research Network — San Diego, California, United States
• MD Clinical — Hallandale, Florida, United States
• Miami Jewish Health Systems — Miami, Florida, United States
• Behavioral Clinical Research — North Miami, Florida, United States
• Bioclinica Research — Orlando, Florida, United States
• Princeton Medical Institute — Princeton, New Jersey, United States
• Serenity Inpatient — DeSoto, Texas, United States
• PRA Health Sciences — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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