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Tracking Information | |||||
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First Received Date † | September 8, 2005 | ||||
Last Updated Date | September 8, 2005 | ||||
Start Date † | September 2005 | ||||
Current Primary Outcome Measures † |
ADAS-Cog | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer’s Disease | ||||
Official Title † | A Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of DCB-AD1 in Patients With Mild to Moderate Alzheimer’s Disease | ||||
Brief Summary | A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of DCB-AD1 in Patients with Mild to Moderate Alzheimer’s Disease. Because of the limitation of the sample size we could expect but a positive trend of the efficacy unless the effect size of DCB-AD1 is larger than 0.63. This information will provide us clue if further clinical investigation such as a phase III study should be carried out in an even larger scale. We also should be able to obtain valuable experience on the adverse effect of prolonged (24-week) use of Fo-ti. |
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Detailed Description | The growing number of patients with dementia has become a great concern of many aging societies. Up to this moment no treatment can stop Alzheimer’s dementia (AD), thus, developing new treatments are still mandatory. In this study we will investigate a new drug DCB-AD1, an herbal medicine derived from root of Fo-ti. Historically the Chinese used the Fo-ti root for its rejuvenating properties to treat premature aging, weakness and so on. In DCB (Development Center of Biotechnology)’s preliminary studies using human neuroblastoma cell, SK-N-SH, Fo-ti water extracts exhibited high potential in preventing A-beta and hydrogen peroxide-induced cell death. From two different AD animal models, DCB have observed neuroprotection effects of Fo-ti using water maze and hole-board exploration tests, Though the pharmacological effect of Fo-ti has yet been clarified, its protective effect may result from radical scavenging activities, anti-inflammatory effect or anti-peroxidation. We intend to investigate DCB-AD1 on its cognitive and neurophysiological effects on Alzheimer disease through a randomized, double-blind, placebo-controlled therapeutic trial for 24 weeks. We will complete 80 eligible cases for analysis in this clinical trial with 40 in each investigation site. The estimated drop-out rate is around 25~30 %. Patients are eligible if they fulfill criteria for a diagnosis of probable AD of NINCDS-ADRDA. We will include patients with Mini-Mental State Examination scores of 12~24 and Clinical Dementia Rating 1 or 2. Patients will be allowed to take cholinesterase inhibitors, donepezil, rivastigmine, galantamine or memantine if the dose has been unchanged for the last 3 months before the study entry and remains stable during the 24-week study period. As for the outcome measures, the primary end point will be the score changes of ADAS-Cog at the end of treatment from the baseline. Secondary end points include CIBIC-PLUS, IADL, Behav-AD, MMSE and CDR. The statistic analysis will be on both intention-to-treat and completed cases. Because of the limitation of the sample size we would expect but a positive trend of the efficacy unless the effect size of DCB-AD1 is larger than 0.63. This information will provide us clue if further clinical investigation such as a phase III study should be carried out in an even larger scale. We will valuable experience on the adverse effect of prolonged (24-week) use of Fo-ti. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Dementia, Alzheimer Type | ||||
Intervention † | Drug: DCB-AD1 | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Not yet recruiting | ||||
Enrollment † | 80 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | Taiwan | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00154635 | ||||
Responsible Party | |||||
Secondary IDs †† | NTUH IRB 931006, VGH IRB 93-11-06, DCB-AD1-01-01 | ||||
Study Sponsor † | National Taiwan University Hospital | ||||
Collaborators †† |
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Investigators † |
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Information Provided By | National Taiwan University Hospital | ||||
Verification Date | September 2005 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |