NCT00527969

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2007

Completed
Last Updated

March 12, 2008

Status Verified

March 1, 2008

First QC Date

September 10, 2007

Last Update Submit

March 10, 2008

Conditions

MemoryLearningAttentionCognitionWell-Being

Keywords

American ginseng extractPanax quinquefoliusMemory enhancementCognitive functionWorking memoryDeclarative memoryPsychomotor speedExecutive skillsPsychosocial adaptation

Outcome Measures

Primary Outcomes (1)

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

    3 weeks

Secondary Outcomes (1)

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

    3 weeks

Interventions

HT1001 extract of Panax quinquefolius LDRUG

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PNL

Edmonton, Alberta, T5J2W4, Canada

Location

Study Officials

  • Scot E Purdon, PhD

    Department of Psychiatry, University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 11, 2007

Study Start

July 1, 2007

Last Updated

March 12, 2008

Record last verified: 2008-03

Locations

CA(1)