Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154635
Status:
UNKNOWN
Last Update Posted:
2005-09-12
First Post:
2005-09-08
Brief Title:
Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimers Disease
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Double-Blind Randomized Placebo Controlled Study to Evaluate the Efficacy and Safety of DCB-AD1 in Patients With Mild to Moderate Alzheimers Disease
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Double-blind Randomized Placebo Controlled Study to Evaluate the Efficacy and Safety of DCB-AD1 in Patients with Mild to Moderate Alzheimers 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 063 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
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 Alzheimers 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 Biotechnologys 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 2530 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 1224 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 063 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
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 063 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NTUH IRB 931006 | None | None | None |
| VGH IRB 93-11-06 | None | None | None |
| DCB-AD1-01-01 | None | None | None |