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Effect of Panax Ginseng on the Cognitive Performance in Alzheimer's Disease

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: NCT00391833
Recruitment Status : Completed
First Posted : October 24, 2006
Last Update Posted : October 24, 2006
Sponsor:
Information provided by:
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE October 22, 2006
First Posted Date  ICMJE October 24, 2006
Last Update Posted Date October 24, 2006
Study Start Date  ICMJE April 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October¬†22,¬†2006)
  • Cognitive performances monitored by MMSE and Alzheimer's disease assessment scales.
  • Biomarkers including hematopoietic progenitor cell count.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Panax Ginseng on the Cognitive Performance in Alzheimer's Disease
Official Title  ICMJE Not Provided
Brief Summary We investigate the clinical efficacy of Panax ginseng in Alzheimer's disease (AD).
Detailed Description

Alzheimer's disease (AD) is characterized by a progressive decline of memory and intellectual abilities, interfering activity in daily living, the overall quality of life, and ultimately leads to death. Although pharmacologic treatments are currently approved for treating mild- to moderate AD using acetylcholinesterase inhibitors (ACEI) or memantine, the NMDA antagonist, for the advanced stage of AD, the therapeutic efficacies need to be further improved.

For millennia, ginseng or its components have been used to treat medical conditions, and the pharmacologic effects have been demonstrated in cardiovascular, endocrine and immune system (Attele et al., 1999). In means of memory and learning, a number of studies suggested that ginseng can attenuate learning deficits of damaged or ageing brains in rodent models (Kennedy et al., 2003; Zhao and McDaniel, 1998; Nitta et al., 1995). In studies with human healthy participants, correspondently, both acute and chronic dosage of ginseng increased the cognitive performance (Kennedy et al., 2001; Kennedy et al., 2003; D'Angelo et al., 1986; Sorensen and Sonne, 1996).

In this study, we we will investigate the contribution of ginseng treatment in increasing the cognitive improvement of AD patients. In addition, we will test various bio-markers and hematopoietic progenitor cell count in those included patients using their blood samples. Patients with AD as well as memory decline will be included

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer's Disease
  • Memory Decline
Intervention  ICMJE Drug: Panax Ginseng
Study Arms  ICMJE Not Provided
Publications * Lee ST, Chu K, Sim JY, Heo JH, Kim M. Panax ginseng enhances cognitive performance in Alzheimer disease. Alzheimer Dis Assoc Disord. 2008 Jul-Sep;22(3):222-6. doi: 10.1097/WAD.0b013e31816c92e6.

*   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
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Alzheimer's disease

Exclusion Criteria:

  • other neurologic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 83 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00391833
Other Study ID Numbers  ICMJE ginseng-AD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Manho Kim, MD, PhD Department of Neurology, Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date October 2006

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