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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2019-12-17

Brief Summary

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

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Detailed Description

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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.

Conditions

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Severe Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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GRF6019

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

Group Type EXPERIMENTAL

GRF6019

Intervention Type DRUG

GRF6019 for IV infusion

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo for IV infusion

Interventions

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GRF6019

GRF6019 for IV infusion

Intervention Type DRUG

Placebo

Placebo for IV infusion

Intervention Type OTHER

Other Intervention Names

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Normal Saline

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No