NCT01023867

Brief Summary

To compare the clinical efficacy of donepezil between patients with Alzheimer's disease and Mixed Dementia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

3.3 years

First QC Date

November 30, 2009

Last Update Submit

January 4, 2016

Conditions

Alzheimer's DiseaseDementia

Keywords

Alzheimer's diseaseMixed DementiaDonepezilEfficacyAdverse Event

Outcome Measures

Primary Outcomes (1)

  • Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)

    13 weeks, 26 weeks, 39 weeks, 52 weeks

Secondary Outcomes (3)

  • 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

Study Arms (2)

Alzheimer's disease group

EXPERIMENTAL

Patients with Alzheimer's disease treated donepezil

Drug: donepezil

Mixed Dementia group

EXPERIMENTAL

Patients with Mixed Dementia treated donepezil

Drug: donepezil

Interventions

donepezilDRUG

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

Also known as: donepezil-aricept
Alzheimer's disease groupMixed Dementia group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementiaMixed Dementias

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Brain 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

  • Doh Kwan Kim, PhD, M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

March 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 6, 2016

Record last verified: 2016-01

Locations

KR(1)