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

Alkahest

Status and phase: Completed; Phase 2

Conditions: Severe Alzheimer Disease

Treatments: Other: Placebo; Drug: GRF6019

Study type: Interventional

Funder types: Industry

Identifiers

NCT03765762

Alkahest study 6019-202

Details and patient eligibility

About

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

Full description

This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability and potential cognitive benefit of GRF6019, a human plasma protein fraction. GRF6019 or placebo will be administered intravenously to subjects with severe Alzheimer's disease every day for 5 consecutive days. The total study duration for each subject is approximately 9 weeks.

Enrollment: 26 patients

Sex: All

Ages: 60 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

GRF6019

Experimental group

Description:

Subjects will receive intravenously 250 mL of GRF6019 each day for 5 consecutive days.

Treatment:

Drug: GRF6019

Placebo

Placebo Comparator group

Description:

Subjects will receive intravenously 250 mL of placebo each day for 5 consecutive days.

Treatment:

Other: Placebo