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Also known as CNM-Au8
gold nanocrystals · 2 trials · 2 indications
The change in 31P-MRS NAD+/NADH ratio was measured by a partial volume coil that images the parietal and occipital lobes as a single value with respect to the fraction (%) of the nicotinamide adenine dinucleotide (NAD) signal measured as either the oxidized (NAD+) or reduced form (NADH). The primary endpoint was the mean change from Baseline to Week 12 in the ratio of NAD+ to NADH (NAD+/NADH) in the Intent to Treat population. A paired t-test was used to analyze the mean change from baseline.
Mean change in average NAD+/NADH measured brain Redox Ratio by treatment cohort from Baseline to Week 12.
| Arm | Type | Description |
|---|---|---|
| 7.5mg CNM-Au8 | EXPERIMENTAL | 7.5mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water |
| 15mg CNM-Au8 | EXPERIMENTAL | 15mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water |
| 30mg CNM-Au8 | EXPERIMENTAL | 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water |
| 60mg CNM-Au8 | EXPERIMENTAL | 60mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water |
| Name | Type | Description |
|---|---|---|
| Gold Nanocrystals | DRUG | CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a concentration of up to 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose HDPE containers. The study doses vary by the concentration of gold nanocrystals per milliliter in a volume of 60 mL. |
Inclusion Criteria: 1. Able to understand and give written informed consent and follow study procedures. 2. Male or female, aged 30 - 80 years or age (inclusive) at the time of PD diagnosis. 3. PD subjects will be recruited in accordance with the MDS Clinical Diagnostic Criteria for PD: 1. P...
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Gold Nanocrystals, also known as CNM-Au8, is an investigational small molecule being developed for Multiple Sclerosis and Parkinson's Disease. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Gold Nanocrystals is designed to improve impaired neuronal redox state, which is the balance of oxidation and reduction in brain cells. It is being studied for its effects on cellular energy metabolism in neurological conditions like Multiple Sclerosis and Parkinson's Disease.
Gold Nanocrystals is being developed by Clene Inc., a biopharmaceutical company. Clene Inc. is publicly traded under the ticker symbol CLNN.
Gold Nanocrystals is in Phase 2 clinical development. It has completed two Phase 2 trials, one in Parkinson's Disease and one in Multiple Sclerosis, and is not yet approved by regulatory authorities.
Gold Nanocrystals has completed two Phase 2 trials: NCT03815916 in Parkinson's Disease with 13 participants, and NCT03993171 in Multiple Sclerosis with 33 participants. Both trials were conducted in the United States and were controlled but not randomized or double-blinded.
Yes, Gold Nanocrystals is also known as CNM-Au8. This alternative name is used in clinical trial registrations and scientific literature to refer to the same investigational drug being developed by Clene Inc.