Status:
COMPLETED
A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease
Lead Sponsor:
Alkahest, Inc.
Conditions:
Severe Alzheimer Disease
Eligibility:
All Genders
60-95 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety, tolerability, and potential cognitive benefit of the experimental treatment GRF6019 in subjects with severe Alzheimer's disease.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2019
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03765762
Start Date
January 15 2019
End Date
December 17 2019
Last Update
January 27 2021
Active Locations (6)
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1
Cognitive Clinical Trials
Gilbert, Arizona, United States, 85297
2
Cognitive Clinical Trials
Mesa, Arizona, United States, 85209
3
Cognitive Clinical Trials
Phoenix, Arizona, United States, 85037
4
Pacific Research Network
San Diego, California, United States, 92103