Cognitive, Emotional, Physical and Psychosocial Effects of Panax Quinquefolius L
Condition: Memory; Learning; Attention; Cognition; Well-Being
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of REMEMBER-fX (HT1001, an
      extract of Panax quinquefolius) in a human sample using standard clinical neuropsychological
      instruments and side effects rating scales.
    

Detailed description: 
      Panax ginseng has been used in Asia for thousands of years to improve vitality, wakefulness,
      respiration, angina, nausea, attention, memory, and diminished libido. More recently, Panax
      extracts have become one of the most popular commercial herbal dietary supplements in the
      West as well. Unfortunately, a limited understanding of the bioactive ingredients within the
      Panax extracts resulted in a wide spectrum of available products with no guidelines for
      standardization. The lack of standardization undermined any legitimate attempt to validate
      the claimed health benefits of the extracts. However, recent advances in the identification,
      quantification, and standardization of extract components with demonstrated systemic and
      neurological actions in animals have created a novel opportunity for the controlled clinical
      investigation of some Panax extracts.

      A significant improvement in the standardization of Panax extracts occurred approximately 20
      years ago with the introduction of a 4% minimum ginsenoside content in a formulation of Panax
      ginseng C V Meyer under the trademark G115 by Pharmaton in Lugano Switzerland. This prompted
      a series of investigations of short-term cognitive, physical, emotional, and psychosocial
      benefits from a single dose of G115. Idiosyncratic cognitive gains were reported, but no
      reliable benefits were observed in physical, emotional, or psychosocial status. Several
      studies have examined the cognitive, physical, emotional, and psychosocial benefits from
      sustained exposure to G115, but these studies are few in number and often failed to include
      standardized behavioural measures or controlled Panax extracts.

      Over the past five years, refinements in high pressure liquid chromatography (HPLC) have
      allowed greater precision in Panax constituent analysis, with significant implications to the
      investigation of the safety and efficacy of Panax extracts in human populations. HPLC has
      been used to identify and quantify several promising neuroactive ginsenosides that are likely
      relevant to the human bioactive effect of Panax extracts. Most notable are the Rg1 and Rb1
      ginsenosides from Panax quinquefolius L which show a number of interesting in vitro effects
      on animal tissue from the central nervous system that have led to several positive results
      from studies of animal learning. Most significant, however, was the introduction of HT1001, a
      precisely standardized proprietary combination of Rg1 and Rb1 ginsenosides developed by CV
      Technologies in Edmonton, Alberta, Canada. Each product lot of HT1001 from CV Technologies is
      tested to ensure consistency of the ginsenoside composition. The introduction of a commercial
      product with a precise standardized composition of Rb1 and Rg1 has created a unique
      opportunity for investigating the safety and efficacy of Panax extracts.
    

Intervention name(s): HT1001 extract of Panax quinquefolius L
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: American ginseng extract; Panax quinquefolius; Memory enhancement; Cognitive function; Working memory; Declarative memory; Psychomotor speed; Executive skills; Psychosocial adaptation