A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and tolerability of LN19184 (Nutricog) to improve cognitive function in aging human volunteers

Citation: A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and tolerability of LN19184 (Nutricog) to improve cognitive function in aging human volunteers. [Data on file]

Abstract:

Objectives and Methodology: The primary objective of this randomized, double-blind, placebo-controlled group study was to evaluate the efficacy of LN19184 (Nutricog) in improving cognitive function in healthy, ageing human volunteers. The secondary objective was to assess safety and tolerability. A total of 100 male and female subjects aged between 40-65 years, with body mass index (BMI) of 18 – 29.9 kg/m2 with subjective memory complaints, were enrolled. Investigation product was administered as a capsule containing 300 mg of LN19184 or a matching placebo once per day before breakfast.

Efficacy: Rey Auditory Verbal Learning Test (RAVLT) was used to assess the efficacy of LN19184 on improving immediate and recall memory. RAVLT is a well-recognized measure of a person's ability to encode, combine, store and recover verbal information in different stages of immediate memory. Following 120 days of supplementation, LN19184 significantly increased the participants’ ability to recall (both immediate and delayed) and recognize the words in RAVLT. In addition, participants in the LN19184 arm showed significantly better resistance to proactive interference. This clearly shows that LN19184 significantly improves immediate and recall memory.

The Cambridge Neuropsychological Test Automated Battery (CANTAB) was used to evaluate the efficacy of LN19184 on attention, vigilance, reaction time, vigilance behavior, working memory and executive function of the study participants. Early and significant improvement in vigilance, visual matching ability, and short-term recognition memory was observed with supplementation of LN19184. Likewise, LN19184 supplementation also improved executive function and working memory, as witnessed by the scores of the spatial working memory (SWM) test and spatial span test (SSP). Participants in the LN19184 group also showed significantly better reaction time, and visual episodic memory improvements. In addition, LN19184 supplementation significantly improved the participants’ ability to manage conflicting information, learning behaviour, multi-tasking ability and visual attention than the placebo cohort.

Following 120 days of supplementation with LN19184, significant improvement was observed in study participants' sleep quality starting from day 15 to the end of the supplementation. Further, serum BDNF, a marker of neuronal maintenance, plasticity, and neurogenesis, was significantly improved from baseline and compared to placebo in the LN19184 group. These observations suggest that LN19184 improved the sleep quality and neuronal plasticity of study participants following 120 days of supplementation. Overall, the participants well-tolerated the study supplement during the study.

Conclusion: The observations of the present study demonstrate that 120 days of supplementation of LN19184 significantly improves the immediate and delayed recall memory, recognition ability, visual attention, vigilance behavior, working memory, executive function, ability to process visuospatial information, multi-tasking ability, and ability to manage conflicting information of the study participants. In addition, LN19184 significantly improves the quality of sleep and neuronal plasticity. This study further demonstrates that LN19184 supplementation was well-tolerated by the participants.