Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer’s Disease
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|ClinicalTrials.gov Identifier: NCT00154635|
Recruitment Status : Unknown
Verified September 2005 by National Taiwan University Hospital.
Recruitment status was: Not yet recruiting
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
|Condition or disease||Intervention/treatment||Phase|
|Dementia, Alzheimer Type||Drug: DCB-AD1||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||September 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154635
|Contact: Ming-Jang Chiu, MD, PhDfirstname.lastname@example.org|
|Taipei, Taiwan, 100|
|Contact: Ming-Jang Chiu, MD, PhD 886-968661507 email@example.com|
|Principal Investigator: Ming-Jang Chiu, MD, PhD|
|Contact: Hsiu-Chih Liu, MD 886-2-28757492 firstname.lastname@example.org|
|Principal Investigator: Hsiu-Chih Liu, MD|
|Principal Investigator:||Ming-Jang Chiu, MD, PhD||NTUH|