Clinical Trial of Donepezil Between the Naive Group and the Switching Group

Dementia Clinical Trial

Official title:

Comparative Assessment of Clinical Efficacy of Donepezil Between the Naive Group and the Switching Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023425
• Other study ID #: 2008-02-072
• Status: Completed
• Phase: N/A
• First received: November 30, 2009
• Last updated: January 4, 2016
• Start date: February 2008
• Est. completion date: April 2009

Study information

• Verified date: January 2016
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To compare the clinical efficacy of donepezil between the naive group and the switching group.

Description:

The purposes of this study are:

1. to compare the efficacy between switching patients with Alzheimer's disease (AD) from galantamine or rivastigmine to donepezil because they were not responding adequately, and naive patients with AD who initiated therapy with donepezil

2. to help to clinicians in choosing the best treatment

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA

2. Korean version Mini-Mental State Examination scores between 10 and 26

3. History of cognitive decline that had been gradual in onset and progressive over at least 6 months

4. A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.

Exclusion Criteria:

1. they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)

2. Psychiatric disorder or severe behavioral disturbances that required psychotropic medications

3. Cerebral injuries induced by trauma, hypoxia, and/or ischemia

4. Clinically active cerebrovascular disease; History of seizure disorder

5. Other physical conditions that required acute treatment.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Drug:
• donepezil
from 5mg to 10mg, once a day, 12 months

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)		13 weeks, 26 weeks, 39 weeks, 52 weeks	Yes
Secondary	Seoul Activities of Daily Living (S-ADL)		13 weeks, 26 weeks, 39 weeks, 52 weeks	Yes
Secondary	Seoul-Instrumental Activities of Daily Living (S-IADL)		13 weeks, 26 weeks, 39 weeks, 52 weeks	Yes
Secondary	Korean Neuropsychiatric Inventory (K-NPI)		13 weeks, 26 weeks, 39 weeks, 52 weeks	Yes