NCT00154635

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 12, 2005

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

September 8, 2005

Conditions

Dementia, Alzheimer Type

Keywords

Alzheimer's diseaseFo-tiChinese herbs

Outcome Measures

Primary Outcomes (1)

  • ADAS-Cog

Secondary Outcomes (5)

  • CIBIC-PLUS

  • IADL

  • Behav-AD

  • MMSE

  • CDR

Interventions

DCB-AD1DRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NTUH

Taipei, Taipei, 100, Taiwan

Location

VGH

Taipei, Taipei, Taiwan

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Ming-Jang Chiu, MD, PhD

    NTUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Jang Chiu, MD, PhD

CONTACT

886-968661507mjchiu@ntumc.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2005

Last Updated

September 12, 2005

Record last verified: 2005-09

Locations

TW(2)