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

Completed · Phase 2 · Has a placebo group

Conditions studied: Severe Alzheimer Disease

In brief

This study will evaluate the safety, tolerability, and potential cognitive benefit of the experimental treatment GRF6019 in subjects with severe Alzheimer's disease.

Key facts

Study ID

NCT03765762

Run by

Alkahest, Inc.

People needed

26

Starts

2019-01-15

Expected to finish

2019-12-17

Last updated by the study team

2021-01-27

Who can join

Age: 60 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) Criteria
• MMSE Score 0-10 inclusive
• Modified Hachinski Ischemia Scale (MHIS) score of 4 or less
• Provided a signed and dated informed consent form (either the subject and/or subject's legal representative)

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.
• Unstable coronary heart disease, e.g. myocardial infarction or severe or unstable angina in the 6 months prior to dosing.
• Moderate to severe congestive heart failure (New York Association Class III or IV).
• Poorly controlled high blood pressure (systolic blood pressure of 160 mmHg or higher and/or diastolic blood pressure of 100 mmHg or higher) despite treatment during the 3 months prior to dosing, or treatment refractory high blood pressure, defined as treatment requiring 3 or more antihypertensives from different classes.
• 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

• Cognitive Clinical Trials — Gilbert, Arizona, United States
• Cognitive Clinical Trials — Mesa, Arizona, United States
• Cognitive Clinical Trials — Phoenix, Arizona, United States
• Pacific Research Network — San Diego, California, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• Bio Behavioral Health — Toms River, New Jersey, United States

Full record on ClinicalTrials.gov

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