31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's … (NCT03815916) | Clinical Trial Compass
CompletedPhase 2
31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's Disease
United States13 participantsStarted 2019-12-19
Plain-language 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).
Who can participate
Age range30 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Able to understand and give written informed consent and follow study procedures.
✓. Male or female, aged 30 - 80 years or age (inclusive) at the time of PD diagnosis.
✓. PD subjects will be recruited in accordance with the MDS Clinical Diagnostic Criteria for
✓. Parkinsonism present (bradykinesia + either rest tremor or rigidity)
✓. 2 of the following 4 supportive criteria:
✓. Duration of PD since diagnosis is \</= 3 years (inclusive)
✓. Modified Hoehn and Yahr stage \</= 3
✓. Treatment with dopaminergic therapy for at least 12-weeks and with no change in current medications within the prior 6-weeks
Exclusion criteria
✕. Atypical parkinsonism, including that due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or other neurodegenerative disease.
✕. The presence of any of the following:
✕. Unequivocal cerebellar abnormalities
✕. Downward vertical gaze limitation or slowing of downward saccades
✕. Diagnosis of behavioral variant frontotemporal dementia or primary progressive aphasia