- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01023867
Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
January 4, 2016 updated by: Doh Kwan Kim, Samsung Medical Center
Comparative Assessment of Clinical Efficacy of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia
To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.
Study Overview
Detailed Description
The purposes of this study are:
- to compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia
- to help to clinicians in choosing the best treatment for patients with mixed dementia
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul City, Korea, Republic of, 135-710
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- A diagnosis of probable AD and Mixed Dementia according to the criteria of the NINCDS-ADRDA
- Korean version Mini-Mental State Examination scores between 10 and 26
- History of cognitive decline that had been gradual in onset and progressive over at least 6 months
- A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
Exclusion Criteria:
- they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
- Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
- Cerebral injuries induced by trauma, hypoxia, and/or ischemia
- Clinically active cerebrovascular disease; History of seizure disorder
- Other physical conditions that required acute treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alzheimer's disease group
Patients with Alzheimer's disease treated donepezil
|
from 5mg to 10mg, once a day, 12 months
Other Names:
|
Experimental: Mixed Dementia group
Patients with Mixed Dementia treated donepezil
|
from 5mg to 10mg, once a day, 12 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)
Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
|
13 weeks, 26 weeks, 39 weeks, 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Seoul Activities of Daily Living (S-ADL)
Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
|
13 weeks, 26 weeks, 39 weeks, 52 weeks
|
Seoul-Instrumental Activities of Daily Living (S-IADL)
Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
|
13 weeks, 26 weeks, 39 weeks, 52 weeks
|
Korean Neuropsychiatric Inventory (K-NPI)
Time Frame: 13 weeks, 26 weeks, 39 weeks, 52 weeks
|
13 weeks, 26 weeks, 39 weeks, 52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
November 30, 2009
First Submitted That Met QC Criteria
December 1, 2009
First Posted (Estimate)
December 2, 2009
Study Record Updates
Last Update Posted (Estimate)
January 6, 2016
Last Update Submitted That Met QC Criteria
January 4, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Dementia
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- 2007-03-039
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityRecruitingDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeRecruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Temple UniversityRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
-
Cognito Therapeutics, Inc.Enrolling by invitationExtension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)Cognitive Impairment | Alzheimer Disease | Mild Cognitive Impairment | Dementia Alzheimers | Dementia of Alzheimer Type | AD | Dementia, Mild | Dementia ModerateUnited States
-
University College, LondonNot yet recruitingDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal | DEM
-
University College, LondonThe University of Hong KongUnknownDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal
-
Karolinska InstitutetRegion Stockholm; KTH Royal Institute of TechnologyActive, not recruitingAlzheimer Dementia | Dementia DisordersSweden
Clinical Trials on donepezil
-
Eisai Inc.Eisai LimitedCompleted
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
Corium, Inc.CompletedAlzheimer DiseaseUnited States
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
Eisai Inc.PfizerTerminatedCognitive Dysfunction | Down SyndromeUnited States
-
Eisai Inc.PfizerTerminatedCognitive Dysfunction | Down SyndromeUnited States
-
Eisai Inc.CompletedMigraine HeadacheUnited States
-
The First Affiliated Hospital with Nanjing Medical...Unknown
-
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.Completed
-
Ever Neuro Pharma GmbHacromion GmbHCompleted