The NICE trial (Neuroprotection with Coenzyme Q10 in Atypical Parkinsonism) was a Phase 3 randomized, double-blind, placebo-controlled study investigating the effects of high-dose Coenzyme Q10 (CoQ10) in patients with Progressive Supranuclear Palsy (PSP).
Key Trial Information
| Parameter | Value | |-----------|-------| | Trial ID | NCT04564555 | | Phase | Phase 3 | | Indication | Progressive Supranuclear Palsy | | Sponsor | University of Pennsylvania / National Institute of Neurological Disorders and Stroke (NINDS) | | Status | Completed | | Enrollment | 350 patients | | Duration | 36 months (3 years) | | Primary Endpoint | Change in PSP Rating Scale (PSPRS) |
Scientific Rationale
Mitochondrial Dysfunction in PSP
PSP is characterized by significant mitochondrial abnormalities that contribute to neuronal degeneration:
Complex I deficiency: Documented in PSP substantia nigra neurons, leading to impaired ATP production
Increased oxidative stress: Elevated reactive oxygen species (ROS) due to mitochondrial dysfunction
Energy crisis: Reduced cellular energy in affected brain regions including the brainstem and basal ganglia
CoQ10 Mechanism of Action
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Coenzyme Q10 in Progressive Supranuclear Palsy (NICE Trial - NCT04564555)
Trial Overview
Mermaid diagram (expand to render)
The NICE trial (Neuroprotection with Coenzyme Q10 in Atypical Parkinsonism) was a Phase 3 randomized, double-blind, placebo-controlled study investigating the effects of high-dose Coenzyme Q10 (CoQ10) in patients with Progressive Supranuclear Palsy (PSP).
Key Trial Information
| Parameter | Value | |-----------|-------| | Trial ID | NCT04564555 | | Phase | Phase 3 | | Indication | Progressive Supranuclear Palsy | | Sponsor | University of Pennsylvania / National Institute of Neurological Disorders and Stroke (NINDS) | | Status | Completed | | Enrollment | 350 patients | | Duration | 36 months (3 years) | | Primary Endpoint | Change in PSP Rating Scale (PSPRS) |
Scientific Rationale
Mitochondrial Dysfunction in PSP
PSP is characterized by significant mitochondrial abnormalities that contribute to neuronal degeneration:
Complex I deficiency: Documented in PSP substantia nigra neurons, leading to impaired ATP production
Increased oxidative stress: Elevated reactive oxygen species (ROS) due to mitochondrial dysfunction
Energy crisis: Reduced cellular energy in affected brain regions including the brainstem and basal ganglia
CoQ10 Mechanism of Action
Coenzyme Q10 (ubiquinone) is a vital component of the mitochondrial electron transport chain:
Electron carrier: Transfers electrons between Complex I/II and Complex III
Antioxidant: Protects mitochondrial membranes from oxidative damage
Bioenergetic support: Enhances ATP production efficiency
Membrane stabilization: Protects neuronal membranes from peroxidation