6th Edition of Neurology World Conference 2026

Abstract

The hippocampus is critical for learning, and memory contains neural progenitor cells. The hippocampus continues to generate new neurons throughout life, a process known as adult hippocampal neurogenesis (AHN). Hippocampal neurogenesis is persistent through the tenth decade of human life and is detectable in patients with Alzheimer’s disease (AD). There was a marked and progressive decline of DCX+ cell numbers in AD patients compared to neurologically healthy individuals. AHN impairment compromises hippocampal function in AD and MCI. This indicates that reduced AHN causes memory impairments and cognitive deterioration in the disease. In addition, AHN is crucial for the regulation of mood. If disturbed, it can have severe consequences for mental health. AHN has been shown to be involved in Major Depressive Disorder (MDD) and Alzheimer’s disease pathology. It was observed that AHN impairment takes place before the presence of senile plaques and neurofibrillary tangles (NFTs), both of which are key pathological hallmarks of AD in the dentate gyrus. We proposed that stimulating inherent AHN could be a therapeutic target for improving cognitive function and promoting synaptic resilience. The clinical trials of a new drug, NA-831, presented here provide some evidence that AHN is involved in both AD and MDD,

Phase 2A Clinical Trials of NA-831 for the treatment of Alzheimer’s Disease

We reviewed a case study using the results of the Phase 2A study of NA-831 to treat Alzheimer’s disease. NA-831 is a small drug molecule that easily crosses the blood-brain barrier with excellent bioavailability. The drug exhibits neuroprotection, neurogenesis, and memory-enhancing properties. A randomized clinical trial of NA-831 was performed on 112 participants with mild and moderate Alzheimer’s disease. Half received the drugs, and half received a placebo. The patients with MCI received 10 mg of NA-831 or placebo orally daily. The patients with mild and moderate Alzheimer’s disease received 30 mg of NA-831 or placebo orally per day. Subjects with MCI to meet the NIA-AA core clinical criteria for mild cognitive impairment due to Alzheimer's disease. CDR score of 0.5 and a Memory Box score of 0.5 or greater at Screening and Baseline. MMSE score ≥22. Subjects with mild & moderate Alzheimer’s disease to meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia. MMSE: 17-21. NA-831 showed a significant improvement for patients with mild and moderate AD with the ADAS-Cog-13 score change of an average of 4.1 as compared to the placebo after 24 weeks of treatment (p = 0.001; ITT). CIBIC-Plus showed 78 % of patients improved (p = 0.01; ITT). mNA831 was well-tolerated at 30 mg/day. There were no serious adverse events observed.

Phase 1B Clinical Trials of NA-831 for Major Depressive Disorder (MDD)

We completed a Phase 1B pilot study, which was a randomized, double-blind, fixed-dose, placebo-controlled, active reference study to investigate the efficacy, safety, and tolerability of two fixed doses (20 and 40 mg/d) of NA-831 vs. that of placebo after 6-week treatment in 32 adult patients with major depressive disorder (MDD). Venlafaxine XR was used as the active reference. The most common adverse effects reported in the functional NA-831 treatment groups were mild headache and dry mouth. Both doses of NA-831 resulted in a significant improvement compared to placebo on the primary efficacy analysis. The difference between active treatment and placebo of ∼7 points on the MADRS translates into a clinically relevant difference in response rates of 32.5 % units, compared to an average of 16% units for antidepressants approved by the USA and European health authorities. Treatment with NA-831 for 6 weeks was well tolerated and efficacious in reducing depressive and anxious symptoms in patients with MDD. Conclusion: The Neurogenesis Hypothesis has been shown to be a viable approach for further research for Alzheimer’s disease (AD) and Major Depressive Disorder (MDD). Biomed is in the process of conducting Phase 2B and Phase 3 trials of NA-831 for the treatment of AD and MDD.