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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01023425

Enrollment

Registered

2009-12-02

Start date

2008-02-29

Completion date

2009-04-30

Last updated

2016-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Dementia

Keywords

naive group, switching group, treatment response, Efficacy, Adverse event

Brief summary

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

Detailed 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

Interventions

DRUGdonepezil

from 5mg to 10mg, once a day, 12 months

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)	13 weeks, 26 weeks, 39 weeks, 52 weeks

Secondary

Measure	Time frame
Seoul Activities of Daily Living (S-ADL)	13 weeks, 26 weeks, 39 weeks, 52 weeks
Seoul-Instrumental Activities of Daily Living (S-IADL)	13 weeks, 26 weeks, 39 weeks, 52 weeks
Korean Neuropsychiatric Inventory (K-NPI)	13 weeks, 26 weeks, 39 weeks, 52 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026