Phase 2
Completed N=47
A Randomized Study to Assess the Safety of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease
Alzheimer's Disease · Mild to Moderate Alzheimer Disease
Source: ClinicalTrials.gov NCT03520998 ↗
Enrolled (actual)
47
Serious AEs
4.3%
Results posted
Nov 2020
Primary outcomePrimary: Frequency of Treatment-emergent Adverse Events (Safety) — 18; 20 Participants
Summary
This study is evaluating the safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with mild to moderate Alzheimer's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Treatment-emergent Adverse Events (Safety) |
18; 20 | — |
| SECONDARY The Mini-Mental State Examination (MMSE) |
-1.0; 1.5 | — |
| SECONDARY Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADASCog/11) |
-0.4; -0.9 | — |
| SECONDARY The Clinical Dementia Rating Scale - Sum of Boxes (CDR-SOB) |
-0.03; 0.21 | — |
| SECONDARY The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) |
-0.7; -1.3 | — |
| SECONDARY The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) |
4.1; 4.1 | — |
| SECONDARY The Neuropsychiatric Inventory Questionnaire (NPI-Q) |
-2.3; -1.2 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of probable AD based upon the National Institute on Aging-Alzheimer's Association (NIA-AA) Criteria
- MMSE Score 12-24 inclusive
- Modified Hachinski Ischemia Scale (MHIS) score of ≤ 4
- Provided a signed and dated informed consent form (either the subject and/or subject's legal representative as well as the trial partner)
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.
- Initiation or change in the dosage of cholinesterase inhibitors (AChEI), memantine, Axona, vitamin E supplementation or selegiline within 3 months prior to screening.
- Heart disease (or history thereof), as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure (New York Association Class II, III or IV) in the 6 months prior to dosing; uncontrolled high blood pressure (systolic blood pressure of 160 mmHg or higher and/or diastolic blood
- 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.
Data sourced from ClinicalTrials.gov (NCT03520998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.