Phase 2
Completed N=79
A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
Source: ClinicalTrials.gov NCT03713957 ↗Enrolled (actual)
79
Serious AEs
6.6%
Results posted
May 2022
Primary outcomePrimary: Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 45; 20; 5; 0 participants
Summary
This study will evaluate the safety, tolerability, and potential effects on cognition of GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with Parkinson's disease and cognitive impairment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
45; 20; 5; 0 | — |
| SECONDARY The Montreal Cognitive Assessment (MoCA) Score. |
1.30; 0.80 | — |
| SECONDARY Continuity of Attention, Reaction Time Variability, Working Memory, and Episodic Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. |
-0.42; -0.28; 4.67; 2.87; 0.09; -0.04 | — |
| SECONDARY The Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency. |
5.00; -1.59 | — |
| SECONDARY The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 1, 2, 3, and Total Score. |
-8.89; -9.53 | — |
| SECONDARY The Schwab and England Activities of Daily Living (SE-ADL) Scale. |
2; 2; 10; 2; 21; 11 | — |
| SECONDARY The Clinical Impression of Severity Index - PD (CISI-PD). |
-0.54; -0.55 | — |
| SECONDARY The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39). |
-4.88; -6.29 | — |
| SECONDARY The Geriatric Depression Scale-15 (GDS-15). |
0.30; 0.27 | — |
| SECONDARY The Digital Clock Drawing Test (dCDT). |
9.25; 1.58 | — |
| SECONDARY Power of Attention, Cognitive Reaction Time, and Speed of Memory on the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB) as Assessed by Change From Baseline in CDR-CCB. |
28.14; 133.32; -49.49; 35.45; 46.97; 232.33 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Parkinson's Disease (PD), with at least 1 year of PD symptoms.
- Diagnosis of PD with mild cognitive impairment (PD-MCI) or probable or possible Parkinson's disease dementia according to Movement Disorder Society's Clinical Diagnostic criteria.
- Score on the Montreal Cognitive Assessment (MoCA) of 13-25.
- Modified Hoehn and Yahr Stages 1-4.
- Modified Hachinski Ischemic Scale (MHIS) score of 4 or less.
Exclusion Criteria
- History of blood coagulation disorders or hypercoagulability.
- Current use of anticoagulant therapy. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is acceptable.
- Prior hypersensitivity reaction to any human blood product or any IV infusion.
- Treatment with any human blood product, including transfusions and IV immunoglobulin, during the 6 months prior to screening.
- History of immunoglobulin A or haptoglobin deficiency; stroke, anaphylaxis, or thromboembolic complications of IV immunoglobulins.
- Heart disease, as evidenced by myocardial infarction, unstable, new onset or severe angina, or congestive heart failure in the 6 months prior to dosing
- Hemoglobin < 10 g/dL in women and < 11 g/dL in men.
Data sourced from ClinicalTrials.gov (NCT03713957). 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.