Phase 2A Trial of Nicotinamide for Early Alzheimer Disease
Study Overview
This study tested nicotinamide, a coenzyme that may help reduce tau phosphorylation in early Alzheimer Disease (AD).
Trial Details
- Type: Double-blind, randomized, placebo-controlled
- Duration: 48 weeks
- Dose: 1,500 mg of nicotinamide, taken twice daily
Participants
47 participants were enrolled, aged around 74 years, with mild cognitive impairment or mild dementia confirmed by CSF biomarkers.
Primary Outcome
The main goal was to measure changes in tau levels in cerebrospinal fluid (CSF) after 48 weeks. Results showed:
- No significant difference in tau levels between the nicotinamide and placebo groups.
- Some improvements in tau levels were observed in the nicotinamide group, but not statistically significant.
Secondary Outcomes
Other measures included various CSF biomarkers and clinical assessments. Key findings included:
- No significant changes in secondary biomarkers.
- Participants on nicotinamide showed less decline in clinical assessments.
Safety
Nicotinamide was generally safe, with few adverse events reported. Common issues included infections and nervous system disorders.
Conclusion
This study indicates that while nicotinamide is safe, it does not effectively reduce tau levels in patients with early Alzheimer Disease.
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