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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00527969
Recruitment Status : Completed
First Posted : September 11, 2007
Last Update Posted : March 12, 2008
Sponsor:
Information provided by:
Afexa Life Sciences Inc

Tracking Information
First Submitted Date  ICMJE September 10, 2007
First Posted Date  ICMJE September 11, 2007
Last Update Posted Date March 12, 2008
Study Start Date  ICMJE July 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2007)
Use of HT1001 will improve objective measures of psychomotor speed, sustained attention, working memory, declarative memory, and or executive skills. [ Time Frame: 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2007)
Use of HT1001 will be associated with no cognitive or physical adverse effects. [ Time Frame: 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive, Emotional, Physical and Psychosocial Effects of Panax Quinquefolius L
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Memory
  • Learning
  • Attention
  • Cognition
  • Well-Being
Intervention  ICMJE Drug: HT1001 extract of Panax quinquefolius L
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 10, 2007)
72
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00527969
Other Study ID Numbers  ICMJE HT1001-2006-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE CV Technologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scot E Purdon, PhD Department of Psychiatry, University of Alberta
PRS Account Afexa Life Sciences Inc
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP