NCT00165750

Brief Summary

This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2005

Completed
7 months 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
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 20, 2013

Status Verified

November 1, 2013

Enrollment Period

3.4 years

First QC Date

September 12, 2005

Last Update Submit

November 19, 2013

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • MRI, ADAS-cog

    0, 12, 24 weeks

Secondary Outcomes (1)

  • ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus

    0, 12, 24 weeks

Study Arms (1)

1

EXPERIMENTAL
Drug: DONEPEZIL HYDROCHLORIDE

Interventions

DONEPEZIL HYDROCHLORIDEDRUG

One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)

Also known as: Aricept
1

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 60 years old.
  • Probable or possible Alzheimer's Disease according to the DSM-IV and NINCDS-ADRDA.
  • MMSE score of 10\~24, CDR of 1\~2.
  • Patients didn't take acetylcholinesterase inhibitors 4 weeks before screening.
  • Permitted drugs: antipsychiatric drug for BPSD, antidepression drug, tranquilizer, treatment drug for physical disease for example hypertension.

You may not qualify if:

  • Uncontrolled by donepezil because of adverse events.
  • No longer continuing treatment of donepezil for refuse, drug-drug interaction etc.
  • If they have taken concomitant medication which were not allowed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheonnam University Hospital

Gwangju, Gwangju, 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

  • Jihee 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

March 1, 2005

Primary Completion

August 1, 2008

Study Completion

November 1, 2008

Last Updated

November 20, 2013

Record last verified: 2013-11

Locations

KR(1)