Safety and Efficacy of a Novel Dietary Pyrroloquinoline Quinone Disodium Salt on Cognitive Functions in Healthy Volunteers: A Clinical Investigation

Abstract

Cognitive dysfunctions are increasing alarmingly around the world, and researchers are exploring preventive measures for improving brain performance. Pyrroloquinoline quinone (PQQ), a naturally occurring coenzyme in foods, exhibits potent antioxidant activity, and improves diverse functions which includes mitochondrial activation, growth, repair, protection of nerve cells by increased expression of nerve growth factor (NGF) and NGF receptors; and suppression of fibril formation and aggregation of amyloid β. A randomized, double‐blind, placebo‐controlled, parallel‐group clinical investigation (RCT) was conducted over a period of 12 weeks of supplementation of PQQ disodium salt (mnemoPQQ®; p.o.; 21.5 mg/day) in 64 healthy Japanese male and female volunteers (age 40 ‐ <80 Y) to determine the safety and efficacy on improved cognitive function and performance. In another independent study, mnemoPQQ® exhibited broad spectrum safety in a battery of toxicological assessments. No mutagenic potentials were observed. The efficacy of mnemoPQQ® on cognitive performance (memory, attention, judgment, and cognitive flexibility) was examined using Cognitrax as the primary outcome (endpoint), and forgetfulness questionnaire (DECO: Deterioration Cognitive Observee) and Mini‐Mental State Examination‐Japanese (MMSE‐J) as the secondary outcomes (endpoints). A total of 58 subjects (Placebo group = 31; Age = 70.91 ± 3.06 Y, and mnemoPQQ® group = 27; Age = 72.10 ± 3.77 Y) completed the study over a period of 12 weeks. Significant improvements were observed on the Cognitrax’s cognitive function domain score on “composite memory”, “verbal memory”, “reaction time”, “complex attention”, “cognitive flexibility”, “executive function”, and “motor speed” in the mnemoPQQ® group as compared to the placebo group. The DECO index and the MMSE‐J score were also significantly improved in the mnemoPQQ® group. No adverse events were reported. This investigation demonstrates that supplementation of mnemoPQQ® is safe and efficacious in improving memory, attention, judgment, and cognitive function, in middle‐aged to elderly population.