Alzheimer's DiseasePhase 1/2NCT00391833
Effect of Panax Ginseng on the Cognitive Performance in Alzheimer's Disease
A Phase 1/2 study testing Panax Ginseng in people with Alzheimer's Disease and Memory Decline, run by Seoul National University Hospital.
Trial summary
We investigate the clinical efficacy of Panax ginseng in Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 40 to 83 years, women only
- Conditions the study is for
- Alzheimer's Disease, Memory Decline
- What is being tested?
- Panax Ginseng
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2004to Oct 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 83 years
- Women only
- Adult, Older adult
Who may be able to join
- Alzheimer's disease
Who cannot join
- other neurologic disease
About this study
We investigate the clinical efficacy of Panax ginseng in Alzheimer's disease (AD).
Read the 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
- Conditions
- Alzheimer's Disease, Memory Decline
- Being tested
- Panax Ginseng
- Keywords
- Alzheimer's disease, Ginseng, CD34
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panax GinsengDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performances monitored by MMSE and Alzheimer's disease assessment scales.
Biomarkers including hematopoietic progenitor cell count.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startApr 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Manho Kim, MD, PhD, Study chair, Department of Neurology, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391833
- Sponsor's protocol ID
- ginseng-AD
- Status last verified
- Oct 2006
- First submitted
- 22 Oct 2006
- Last updated
- 24 Oct 2006
- Results posted
- No
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.
PubMed 18580589
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Panax Ginseng on the Cognitive Performance in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00391833
- Acronym / sponsor ID
- ginseng-AD
- Conditions
- Alzheimer's Disease, Memory Decline
- Keywords
- Alzheimer's disease, Ginseng, CD34
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Oct 2005
- First posted
- 24 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 83 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Alzheimer's disease
Key exclusion criteria (1 listed)
- other neurologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panax Ginseng | Drug | – |
Primary outcome
Cognitive performances monitored by MMSE and Alzheimer's disease assessment scales.
Biomarkers including hematopoietic progenitor cell count.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2006.
- Derived from this study: PubMed 18580589Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manho Kim, MD, PhD study chair
Department of Neurology, Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Panax Ginseng in people with Alzheimer's Disease and Memory Decline, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive performances monitored by MMSE and Alzheimer's disease assessment scales.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2006.