CClinicalTrials.gg
CompletedNCT00527969REMEMBER-fXUpdated Mar 12, 2008

Cognitive, Emotional, Physical and Psychosocial Effects of Panax Quinquefolius L

A Phase 2 interventional study of HT1001 extract of Panax quinquefolius L in Memory, Learning and Attention, sponsored by CV Technologies. Completed at 1 site in Canada. Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-03-12.

Sponsored by CV Technologies · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
35 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Memory
  • Learning
  • Attention
  • Cognition
  • Well-Being

Keywords

  • American ginseng extract
  • Panax quinquefolius
  • Memory enhancement
  • Cognitive function
  • Working memory
  • Declarative memory
  • Psychomotor speed
  • Executive skills
  • Psychosocial adaptation
03

In context

Lead sponsor

CV Technologies is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy men and women between the age of 35 - 75
  • Women of child bearing capacity who agree to use an acceptable form of birth control during the trial (i.e. oral contraception, reliable use of a double-barrier method (e.g. condom and diaphragm, condom and foam, condom and sponge), IUD or tubal ligation)
  • Achievement Test (WRAT-III) score greater than 70 with a reading level within normal limits as defined by a Wide Range
  • Willing to adhere to the requirements of the protocol, including availability for follow-up visits
  • Willing and able to sign written informed consent

Exclusion criteria

Exclusion Criteria:

  • Medical conditions;
  • HIV/AIDS
  • Malignancy (under active observation or treatment)
  • Unstable cardiovascular disease (physician visit or hospitalization for unstable cardiovascular disease in the last 6 mo.)
  • Renal Abnormalities (serum creatinine known to be > 200umol/L)
  • Acute or active chronic liver disease
  • Diabetes
  • Neurologic or psychiatric disease (progressive or currently under treatment)
  • Active tuberculosis
  • Multiple sclerosis
  • Bleeding disorders
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
72 participants (estimated)

Interventions

  • DrugHT1001 extract of Panax quinquefolius L
06

What researchers measure

Primary outcomes

  1. Use of HT1001 will improve objective measures of psychomotor speed, sustained attention, working memory, declarative memory, and or executive skills.

    Time frame: 3 weeks

Secondary outcomes

  1. Use of HT1001 will be associated with no cognitive or physical adverse effects.

    Time frame: 3 weeks

07

Study locations

1 site
  • PNL
    Edmonton, Alberta T5J2W4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00527969
Lead sponsor
CV Technologies
First posted
Sep 11, 2007
Start date
Jul 2007
Last update
Mar 12, 2008

Study contacts

Scot E Purdon, PhD
principal investigator · Department of Psychiatry, University of Alberta

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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