Title : INTRODUCING the neurogenesis hypothesis with a case study- phase 2A clinical trials of na-831 for the treatment of Alzheimer's disease
In the hippocampus, new neurons are generated throughout life via a process called adult hippocampal neurogenesis (AHN). In mild cognitive impairment (MCI) and mild to moderate AD (early AD), AHN is significantly reduced suggesting that AHN impairment compromises hippocampal functions. Accordingly, augmenting AHN could help prevent or slow cognitive decline in MCI and early AD.
NA-831 is a small drug molecule, which activates synaptic AMPA receptors, and increases the expression of BDNF (brain derived neurotrophic factor). BDNF is crucial in synaptic plasticity, learning and memory formation in the hippocampus. NA-831 restores neurogenesis by increasing the number of DCX+PCNA+ neuroblast cells.
A randomized double-blind placebo controlled clinical trial of NA-831 was conducted in 56 patients with Mild Cognitive Impairment and patients with Mild and Moderate AD, who received 30 mg orally of NA-831 versus placebo per day for 24 weeks.
NA-831 provided a significant delay in cognitive decline in MCI as measured by ADAS-Cog-13, an average score difference of 3.4 compared to placebo (p = 0.01; ITT) after 24 weeks of treatment.
Similarly, NA-831 delayed cognitive decline in early AD, an average score difference of 4.1 com-pared to placebo (p= 0.001; ITT). CIBIC-Plus showed 78 % of the study participants receiving NA-831 improved (p = 0.01; ITT). NA-831 was well-tolerated at 30 mg/day for 24 weeks, and no serious adverse events were observed.
The Neurogenesis Hypothesis, and details of these Phase 2A clinical trials will be presented and discussed.
What will audience learn from your presentation?
- We introduce a new hypothesis, known as the Neurogenesis Hypothesis as a potential replacement of the Amyloid Hypothesis. Almost all clinical trials of drugs based on the Amyloid Hypothesis failed over the past 25 years.
- Clinical results of the new drug, NA-831 supports the viability of the Neurogenesis Hypothesis.
- We encourage our colleagues to look into the new hypothesis and your input is appreciated.
- We would welcome collaboration with other researchers from around the world to work with us