NCT00165724

Brief Summary

Open study for efficacy and safety of donepezil treatment during 48 weeks

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2004

Typical duration for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2006

Completed
Last Updated

December 30, 2021

Status Verified

June 1, 2010

Enrollment Period

2.1 years

First QC Date

September 12, 2005

Last Update Submit

December 10, 2021

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • ADAS-cog

Secondary Outcomes (1)

  • MMSE, CDR, GDS, NPI, ADL, SSDQ

Interventions

Donepezil HydrochlorideDRUG

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women aged 40 to 90
  • Diagnosis of dementia according to DSM-IV
  • Diagnosis of probable AD as defined by NINCDS-ADRDA criteria
  • Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26
  • Patients were generally healthy and ambulatory or ambulatory aided
  • Patients did not take acetylcholinesterase inhibitor 4 weeks before screening
  • Patients have useful MRI results 3 months before screening

You may not qualify if:

  • If they have evidence of TIA or major infarction
  • Epilepsy patients
  • If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse
  • If they sensitive to acetylcholinesterase
  • If they taken concomitant medication which were not allowed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Bobath Memorial Hospital

Bundang, South Korea

Location

Bundang Seoul National University Hospital

Bundang, South Korea

Location

Changwon Fatima Hospital

Changwon, South Korea

Location

Yeungnam University Hospital

Daegu, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Catholic University Hospital

Seoul, South Korea

Location

Eulji University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Jiheed Mun

    Eisai Korea Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

June 30, 2004

Primary Completion

July 31, 2006

Study Completion

December 31, 2006

Last Updated

December 30, 2021

Record last verified: 2010-06

Locations

KR(7)