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A Pharmacist's Review of CogniviveTM

Cognivive Review Article

The Alpinia galangal extract (AGE), known as CogniviveTM in Neuriva Ultra, is a thoroughly researched and standardized extract derived from the rhizome of Alpinia galanga. Alpinia galanga originates from Southeast Asia and is utilized as both a culinary ingredient and a medicinal herb in that region. It belongs to the ginger family and bears a resemblance to the ginger rhizome. CogniviveTM excels in its capacity to augment alertness, offering benefits that surpass a simple increase in energy without the use of caffeine. CogniviveTM has been substantiated by five clinical trials, demonstrating its efficacy in enhancing mental alertness, which refers to the capacity to rapidly perceive a given scenario.

A preclinical investigation examining the interaction between brain components and  the phytoconstituents of AGE reveals that they may interact with dopamine and acetylcholine, crucial neurotransmitters involved in promoting alertness and enhancing focus.  CogniviveTM is caffeine free and has been formulated using scientific trials that demonstrate its ability to enhance mental vigilance, a state characterized by heightened receptivity to external stimuli.

AGE was studied in five distinct randomized controlled trials1-4, all conducted in human subjects. AGE has been found to enhance mental alertness2-4, improve accuracy3,4, and alleviate fatigue4. The majority of participants in these trials had moderate caffeine habituation which makes a change in alertness within these participants even more impressive because they were already desensitized to stimulants1,2. Notably, AGE demonstrated sustained positive effects lasting up to five hours3,4 with minimal reported side effects1-4 and relieving caffeine withdrawal effects2. Table 1 summarizes the data from these six clinical studies.

Ultimately, the clinical investigations indicate that AGE has beneficial impacts on human mental acuity, precision, and fatigue.  The data substantiates its significance as a potent substitute for caffeine, catering to those seeking to obtain natural nootropics that enhance cognitive alertness, concentration, and attention without compromising energy levels. Due to its mild yet powerful impact on the brain. It provides long-lasting (up to five hours) effects including increased mental alertness decreased fatigue without the drawbacks associated with conventional stimulants.

Table 1. Comparison of all clinical trial data

 

Trial Objective # of Participants Methodology Measurements Results
1. Sirvastava, S., Pimple, S., 2017

Study the effects of multiple ingredients on mental alertness in caffeine-habituated subjects. Five ingredients (Cymbopogon Flexuosus essential oil from leaves (LG), Alpinia Galanga water-soluble extract (AG1), Alpinia Galanga water-insoluble extract (AG2), Glycyrrhiza Glabra water-soluble extract (GG1), Glycyrrhiza Glabra water-insoluble extract (GG2)

Examined and compared to caffeine and placebo with each group containing ten individuals.
59

A randomized, double-dummy, double-blind, placebo-controlled crossover study in which 59 individuals 18-40 years and body mass index of ≥18.5 and <25.00 kg/m2) with moderate caffeine consumption were enrolled. Administered to participants, followed by sequential administration of remaining interventions on consecutive visits; effects on mental alertness, sustained attention, and sleep architecture, along with safety and tolerability, were analyzed.

Jin Fan's Attention Network Test alertness score of 50 ± 20 ms. Generalized Anxiety Disorder-7 score ≤7, Patient Health Questionnaire-9 score ≤14. Secondary outcomes were measured using the Psychomotor Vigilance Task (PVT) and Karolinska Sleepiness Scale (KSS).

In the E-AG-01 group, the alertness score was increased by 11.65 ± 23.94, 12.50 ± 19.73, and 12.62 ± 0.68 ms from baseline at 1, 3 (p = 0.042), and 5 hours, respectively, indicating its efficacy to enhance mental alertness and the increase in alertness score as compared to placebo.

 

In the composite group (E-AG-01 with caffeine), mean response time, measured using PVT, was significantly reduced, by 15.55 ms (p = 0.026) at 3 hours.
2. Sirvastava, S., Mennemeier, M., 2017 Determine the effect of Alpinia galanga on mental alertness and sustained attention in comparison with or without caffeine and placebo in participants with moderate caffeine intake. 59 Single center, randomized, double-dummy, double-blind, placebo-controlled, cross-over clinical study. Supplement administered in a clinic, 30 minutes post-breakfast (standardized meal of ~200 ca) and baseline testing, as well as 1, 3, and 5 hours post dose. Participants additionally instructed to consume supplement before dinner the same night of the clinic visit. Primary outcome: Mental alertness as assessed by Jin Fan’s Attention Network Test (ANT) alertness; all participants enrolled with a baseline score of 50±20 ms In the E-AG-01 group, there was an increase in alertness score from baseline of 11.65±23.94 (p=0.008) at 1 hour, 12.50±19.73 (p=0.001) at 3 hours, and 12.62±24.71 (p=0.005) at 5 hours. In the placebo group, there was a statistically insignificant increase in alertness score of 5.05±19.71 at 1 hour, 2.61±20.66 at 3 hours, and 9.79±20.07 at 5 hours. In the caffeine group, alertness scores increased from baseline of 8.97±18.20 (p=0.006) at 1 hour, but a decrease in ANT at 3 hours. In the composite group, scores increased similarly by 10.27±20.34 (p=0.004) at 1 hour, then decreased to approximately baseline at 3 hours.
3. Sirvastava, S., Mennemeier, M., 2020 The study aimed to assess the long-term safety and perceivable mental acuity benefits of Alpinia Galanga in healthy individuals. 23 Randomized, placebo-controlled study in which study participants were administered Alpinia Galanga with or without caffeine for a period of 12 weeks. The cardiovascular safety was evaluated by assessing change in QT interval, blood pressure and heart rate. Further, other efficacy variables evaluated were change in perceived alertness and calmness by Bond and Lader mood scales, Sleep disturbance by Pittsburgh sleep quality Index and daytime sleepiness by Epworth sleepiness scale. None of the study group showed any significant change in the ECG or haemodynamic parameters as compared to baseline (p > 0.05). Post consumption, alertness and calmness scores were significantly increased in the Alpinia Galanga, and Alpinia Galanga plus caffeine group (p < 0.001) as compared to placebo. Daytime sleep scores decreased in the Alpinia Galanga group however the change was not significant. Sleep quality remained undisturbed in all three arms.
4. Eraiah, M., Kundapur, M., 2023 Examine acute effects of Alpinia galangal extract (AGE) on mental alertness, accuracy, and weariness 62 Randomized, double-blind, placebo-controlled, cross-over clinical study.
Supplement administered 30 minutes following lunch and testing conducted at baseline, 0.5, 1, 2 & 5 hours post dose. (five-day washout period between treatments)
Primary outcome/(s): Mental alertness as assessed by Symbol Digit Coding (SDC) test, Shifting Attention (SAT) test, Stroop Test (ST) and Alertness Rating Scale (ARS)
Secondary outcomes: fatigue, energy, and vigor scores (visual analogue scale, fatigue severity and daytime sleepiness)
Primary SDC Test: Significant increase in correct responses in the AGE group compared to placebo observed at 0.5- and 2-hour. No effect in reduction of errors. SAT test: Increase in correct responses and decrease in errors at the 1-hour. Stroop test: Decrease in reaction time found at 2- and 5-hour. Alertness Rating Scale: Increase observed at 2- and 5-hour.
Secondary
Visual Analogue Scale- Fatigue Severity Significant decrease in fatigue and increase in energy found 6-7 hours post dose. Epworth Sleepiness Scale- Significant decrease observed in daytime sleepiness found at 1, 2, and 5-hour post dose.
5. Eraiah, M., Kundapur, M., 2023 Examine chronic effects of Alpinia galangal extract (AGE) on mental alertness, accuracy, and weariness. 62 Randomized, double-blind, placebo-controlled, cross-over clinical study.
Participants consumed supplement daily 30 minutes after lunch for 28 days, with a ten day washout period between two periods.
Primary outcome/(s): Mental alertness as assessed by Symbol Digit Coding (SDC) test, Shifting Attention (SAT) test, Stroop Test (ST) and Alertness Rating Scale (ARS)
Secondary outcomes: fatigue, energy, and vigor scores (visual analogue scale, fatigue severity and daytime sleepiness)
Primary: Significant improvement in correct responses for SDC, SAT. SDC and SAT had significant improvement in SDC and SAT. Mean errors were reduced SDC, SAT & ST. Simple reaction time improved on ST and correct responses on SAT. Secondary: Decrease in sleepiness scale scores due to AGE treatment and an increase in in VAS energy score.



References:

  1. Sirvastava, S., Pimple, S., BAOJ (2017). Effect of alpinia galanga on mental alertness and sustained attention with or without caffeine: A randomized placebo-controlled study. Journal of the American College of Nutrition. https://pubmed.ncbi.nlm.nih.gov/28910196/
  2. Srivastava, S., Menneimeier, M., Pimple, S., (2017). Effect of Alpinia galanga on Mental Alertness and Sustained Attention With or Without Caffeine: A Randomized Placebo-Controlled Study. Journal of the American College of Nutrition. http://dx.doi.org/10.1080/07315724.2017.1342576
  3. Sirvastava, S., Mennemeier, M., Chaudhary, J., (2020). A randomized placebo controlled clinical trial demonstrating safety & efficacy of enxtra® in healthy adults. Journal of the American College of Nutrition. https://pubmed.ncbi.nlm.nih.gov/32412358/
  4. Eraiah, M., Kundapur, M. (2023) Acute effects of Alpinia Galanga extract on mental alertness, accuracy ... (n.d.-a). https://crimsonpublishers.com/acam/pdf/ACAM.000669.pdf
  5. Muttanahally, M., Kundapur, M., Josua, L., Thomas, J. (2023). Alpiniagalanga extract increases alertness, focus, and energy while lowering fatigue and daytime sleepiness with four weeks supplementation: a randomized, double-blind, placebo-controlled, cross-over study in human subjects. Current Research in Complementary & Alternative Medicine. https://www.doi.org/10.29011/2577-2201.100209
  6. Alpinia Galanga - Plant finder. (n.d.). https://www.missouribotanicalgarden.org/PlantFinder/PlantFinderDetails.aspx?taxonid=287591

 

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