drugset / Trial / NCT03815916
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's Disease
Phase 2
Completed
13 enrolled
Clene Nanomedicine
University of Texas Southwestern Medical Center · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
REPAIR-PD is a single-center open label pilot, sequential group, investigator and patient blinded study to assess the CNS metabolic effects, safety, pharmacokinetics, and pharmacodynamics of CNM-Au8 in patients who have been diagnosed with Parkinson's Disease (PD) within three (3) years of Screening. The primary endpoint is the ratio of the oxidized to reduced form of nicotinamide adenine dinucleotide (NAD+:NADH) measured non-invasively by 31phosphorous magnetic resonance spectroscopy (31P-MRS).
Timeline
- Start
- 2019-12-19
- Primary completion
- 2021-06-07
- Completion
- 2021-06-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CNM-Au8 | Other / unclassified | 7.5 mg | Oral |
| Subject | CNM-Au8 | Other / unclassified | 15 mg | Oral |
| Subject | CNM-Au8 | Other / unclassified | 30 mg | Oral |
| Subject | CNM-Au8 | Other / unclassified | 60 mg | Oral |