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

• Status: Completed
• Trial end date: 2019-12-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkahest, Inc.

Criteria

Inclusion Criteria:

• 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)

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.

• 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.