Status:
UNKNOWN
Efficacy and Safety Study of DCB-AD1 in Patients With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Development Center for Biotechnology, Taiwan
Taipei Veterans General Hospital, Taiwan
Conditions:
Dementia, Alzheimer Type
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- Male or post menopausal female patients aged ≧50 years old;
- The informed consent must be signed by the patient and co-signed by their proxy or principal caregivers before undergoing any study procedures;
- Probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Alzheimer's dementia and related disorder (NINCDS-ADRDA)
- Patients with Mini-Mental State Examination (MMSE) scores of 12\~24
- Patients with Clinical Dementia Rating (CDR)in mild (CDR = 1) and moderate (CDR = 2) AD
- Cranial computed tomography (CT) or brain magnetic resonance imaging (MRI) must be within the past 12 months;
- Patients must be able to complete baseline assessments;
- An eligible principal caregiver must be able to accompany the patient to all scheduled visits;
- 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.
Exclusion
- 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;
- 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;
- 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;
- Patients with concurrent psychosis or mood disorder (Hamilton depression scale score \> 17);
- Patients diagnosed cancer and treated within the past two years (except for non-invasive skin cancer);
- 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;
- Patients currently treated with any prohibited medications (listed in Concomitant Treatment section) are not able to fulfill the 2 week-washout period;
- Participation in another study within the last 30 days;
- Females who are within two years of their menopause unless proved not pregnant (determined by urine test);
- Dementia caused by other etiology as indicated by clinically significant abnormal Vit B12, folic acid, or thyroid function tests.
- Patients with neurosyphilis confirmed by CSF STS/TPHA;
- The neuroimage CT or MRI could not be compatible with the diagnosis of probable AD as stated in the NINCDS criteria;
- Patients with a Hachinski score (Appendix 5) above 3 are excluded.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00154635
Start Date
September 1 2005
Last Update
September 12 2005
Active Locations (2)
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1
NTUH
Taipei, Taipei, Taiwan, 100
2
VGH
Taipei, Taipei, Taiwan