A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment

A

Alkahest

Status and phase

Completed
Phase 2

Conditions

Parkinson Disease

Treatments

Other: Placebo
Drug: GRF6021

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03713957
Alkahest study 6021-201

Details and patient eligibility

About

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.

Full description

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of GRF6021, a plasma derived product, administered by intravenous (IV) infusion to subjects with Parkinson's disease (PD) and cognitive impairment. The study duration for the subjects will be approximately 7 months.

Enrollment

79 patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

79 participants in 2 patient groups, including a placebo group

GRF6021
Experimental group
Description:
Subjects will receive GRF6021 for 5 consecutive days at Week 1 and Week 13.
Treatment:
Drug: GRF6021
Placebo
Placebo Comparator group
Description:
Subjects will receive Placebo for 5 consecutive days at Week 1 and Week 13.
Treatment:
Other: Placebo

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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