Phase 2
Completed N=26
A Study to Assess the Safety of GRF6019 Infusions in Subjects With Severe Alzheimer's Disease
Severe Alzheimer Disease
Source: ClinicalTrials.gov NCT03765762 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Frequency of Treatment-emergent Adverse Events (Safety) — 8; 3 Participants
Summary
This study will evaluate the safety, tolerability, and potential cognitive benefit of the experimental treatment GRF6019 in subjects with severe Alzheimer's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Treatment-emergent Adverse Events (Safety) |
8; 3 | — |
| PRIMARY Tolerability of GRF6019 |
18; 8 | — |
| SECONDARY The Mini-Mental State Examination (MMSE) Score |
1.3; 1.8 | — |
| SECONDARY Severe Impairment Battery (SIB) Total Score |
6.7; 10.4 | — |
| SECONDARY Alzheimer's Disease Cooperative Study Group Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-Severe) |
1.6; 0.5 | — |
| SECONDARY Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change Plus Caregiver Input (ADCS-CGIC) |
3.9; 4.0 | — |
| SECONDARY Neuropsychiatric Inventory Nursing Home (NPI-NH) Total Score |
-7.0; -20.0 | — |
| SECONDARY Neuropsychiatric Inventory (NPI) Caregiver Total Score |
-3.7; 1.5 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03765762). 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.