Cognitive, Emotional, Physical and Psychosocial Effects of Panax Quinquefolius L (REMEMBER-fX)

This study has been completed.
Sponsor:
Information provided by:
Afexa Life Sciences Inc
ClinicalTrials.gov Identifier:
NCT00527969
First received: September 10, 2007
Last updated: March 10, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Memory
Learning
Attention
Cognition
Well-Being
Drug: HT1001 extract of Panax quinquefolius L
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Cognitive, Emotional, Physical, and Psychosocial Effects of Three Weeks' Prospective Double-Blind Placebo Controlled Cross-Over Exposure to Panax Quinquefolius L (REMEMBER-fX), With Optional Six Months' Open Label Follow-up

Resource links provided by NLM:


Further study details as provided by Afexa Life Sciences Inc:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Use of HT1001 will be associated with no cognitive or physical adverse effects. [ Time Frame: 3 weeks ]

Estimated Enrollment: 72
Study Start Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527969

Locations
Canada, Alberta
PNL
Edmonton, Alberta, Canada, T5J2W4
Sponsors and Collaborators
CV Technologies
Investigators
Principal Investigator: Scot E Purdon, PhD Department of Psychiatry, University of Alberta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00527969     History of Changes
Other Study ID Numbers: HT1001-2006-2
Study First Received: September 10, 2007
Last Updated: March 10, 2008
Health Authority: Canada: Health Canada

Keywords provided by Afexa Life Sciences Inc:
American ginseng extract
Panax quinquefolius
Memory enhancement
Cognitive function
Working memory
Declarative memory
Psychomotor speed
Executive skills
Psychosocial adaptation

ClinicalTrials.gov processed this record on October 22, 2014