Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT00154635
Status:
UNKNOWN
Last Update Posted:
2005-09-12
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'lastUpdateSubmitDate': '2005-09-08', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADAS-Cog'}], 'secondaryOutcomes': [{'measure': 'CIBIC-PLUS'}, {'measure': 'IADL'}, {'measure': 'Behav-AD'}, {'measure': 'MMSE'}, {'measure': 'CDR'}]}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'Fo-ti', 'Chinese herbs'], 'conditions': ['Dementia, Alzheimer Type']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nAs 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or post menopausal female patients aged ≧50 years old;\n2. The informed consent must be signed by the patient and co-signed by their proxy or principal caregivers before undergoing any study procedures;\n3. Probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Alzheimer's dementia and related disorder (NINCDS-ADRDA)\n4. Patients with Mini-Mental State Examination (MMSE) scores of 12\\~24\n5. Patients with Clinical Dementia Rating (CDR)in mild (CDR = 1) and moderate (CDR = 2) AD\n6. Cranial computed tomography (CT) or brain magnetic resonance imaging (MRI) must be within the past 12 months;\n7. Patients must be able to complete baseline assessments;\n8. An eligible principal caregiver must be able to accompany the patient to all scheduled visits;\n9. Patients currently taking ChEIs such as donepezil, rivastigmine, or galantamine are allowed if the dose has been unchanged for the last 3 months before the study entry.\n\nExclusion Criteria:\n\n1. Patients with history of severe systemic disease such as coronary artery disease, myocardial infarct, progressive heart failure, chronic obstructive pulmonary disease within the past 1 year;\n2. Patients with hepatic and renal insufficiency (ALT、AST 3 times above normal range; serum creatinine 2 times above normal range), diabetic patients with poor control of blood sugar (HbA1c\\>8.5) at study entry;\n3. Patients with central nervous system disease other than AD such as cerebral vascular disease, Parkinson's disease, epilepsy, traumatic brain injury, central nervous system infection, and alcoholic encephalopathy;\n4. Patients with concurrent psychosis or mood disorder (Hamilton depression scale score \\> 17);\n5. Patients diagnosed cancer and treated within the past two years (except for non-invasive skin cancer);\n6. Patients with general medical conditions, which may confound the results of the study, pose additional risk or preclude evaluation and assessments in this study as judged by the investigator;\n7. Patients currently treated with any prohibited medications (listed in Concomitant Treatment section) are not able to fulfill the 2 week-washout period;\n8. Participation in another study within the last 30 days;\n9. Females who are within two years of their menopause unless proved not pregnant (determined by urine test);\n10. Dementia caused by other etiology as indicated by clinically significant abnormal Vit B12, folic acid, or thyroid function tests.\n11. Patients with neurosyphilis confirmed by CSF STS/TPHA;\n12. The neuroimage CT or MRI could not be compatible with the diagnosis of probable AD as stated in the NINCDS criteria;\n13. Patients with a Hachinski score (Appendix 5) above 3 are excluded."}, 'identificationModule': {'nctId': 'NCT00154635', 'briefTitle': "Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': '931006'}, 'secondaryIdInfos': [{'id': 'NTUH IRB 931006'}, {'id': 'VGH IRB 93-11-06'}, {'id': 'DCB-AD1-01-01'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'DCB-AD1', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'Ming-Jang Chiu, MD, PhD', 'role': 'CONTACT', 'email': 'mjchiu@ntumc.org', 'phone': '886-968661507'}, {'name': 'Ming-Jang Chiu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NTUH'}, {'city': 'Taipei', 'state': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'Hsiu-Chih Liu, MD', 'role': 'CONTACT', 'email': 'hcliu@vghtpe.gov.tw', 'phone': '886-2-28757492'}, {'name': 'Hsiu-Chih Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VGH'}], 'centralContacts': [{'name': 'Ming-Jang Chiu, MD, PhD', 'role': 'CONTACT', 'email': 'mjchiu@ntumc.org', 'phone': '886-968661507'}], 'overallOfficials': [{'name': 'Ming-Jang Chiu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NTUH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Development Center for Biotechnology, Taiwan', 'class': 'OTHER_GOV'}, {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, {'name': 'Program Office, National Science & Technology, Biotechnology & Pharmaceuticals', 'class': 'UNKNOWN'}]}}}