NCT02415062

Brief Summary

The purpose of this study to evaluate the safety and efficacy of high-dose donepezil (23mg) in Parkinson's disease with dementia compared to standard dose donepezil.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 14, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

March 14, 2015

Last Update Submit

August 5, 2015

Conditions

Parkinson's Disease

Keywords

Parkinson's diseasedementia

Outcome Measures

Primary Outcomes (1)

  • Korean Mini-Mental State Examination-2 (MMSE-2)

    scale for general cognitive function, We used Korean version of MMSE-2 from PAR company

    24 weeks

Secondary Outcomes (9)

  • Korean-Instrumental Activities of Daily Living

    24 weeks

  • Clinical dementia rating

    24 weeks

  • Unified Parkinson's disease rating scale (UPDRS) part 3

    24 weeks

  • Modified Hoehn & Yahr stage

    24 weeks

  • Schwab & England Activities of Daily Living

    24 weeks

  • +4 more secondary outcomes

Study Arms (2)

high dose donepezil (23mg)

EXPERIMENTAL

Patients with dementia in Parkinson's disease, who are treated with high dose donepezil (23mg)

Drug: Donepezil

standard dose denepezil (10mg)

ACTIVE COMPARATOR

Patients with dementia in Parkinson's disease, who are treated with standard dose donepezil (10mg)

Drug: Donepezil

Interventions

DonepezilDRUG

23mg/day for 24 weeks versus 10mg/day for 24 weeks

Also known as: aricept
high dose donepezil (23mg)standard dose denepezil (10mg)

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed as Parkinson's disease according to Queen Brain Bank criteria
  • Patients who have been diagnosed as dementia after diagnosing Parkinson's disease at least 1 year.
  • Patients with Hoehn and Yahr staging from 2 to 4
  • Patients with MMSE score from 10 to 24
  • Patients who have taken donepezil for at least 12 weeks before screening period
  • Patients whose medications for Parkinson's disease have not change for 1 month
  • Patients who give informed consent

You may not qualify if:

  • Patients who cannot be performed neuropsychiatric test because of hearing and visual difficulty
  • Patients who have taken medicine affecting cognitive function such as anticholinergic drug and memantine -Patients diagnosed as dementia with Lewy body and vascular dementia-
  • Patients who have history of neurosyphilis, head trauma, encephalitis or other movement disorders
  • Patients who have psychiatric disease
  • Except patients who are stable state under antidepressant or atypical neuroleptics
  • Patients with child-bearing periods
  • Patients who have severe liver or kidney disease necessary for aggressive treatment
  • Patients who have gastrointestinal disease needed for treatment
  • Patients who cannot taken tablet per oral
  • Patients who are participated in other clinical trial except observational study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje university, busan paik hospital

Busan, South Korea

RECRUITING

Related Publications (3)

  • Ravina B, Putt M, Siderowf A, Farrar JT, Gillespie M, Crawley A, Fernandez HH, Trieschmann MM, Reichwein S, Simuni T. Donepezil for dementia in Parkinson's disease: a randomised, double blind, placebo controlled, crossover study. J Neurol Neurosurg Psychiatry. 2005 Jul;76(7):934-9. doi: 10.1136/jnnp.2004.050682.

    PMID: 15965198BACKGROUND

  • Leroi I, Brandt J, Reich SG, Lyketsos CG, Grill S, Thompson R, Marsh L. Randomized placebo-controlled trial of donepezil in cognitive impairment in Parkinson's disease. Int J Geriatr Psychiatry. 2004 Jan;19(1):1-8. doi: 10.1002/gps.993.

    PMID: 14716693BACKGROUND

  • Aarsland D, Laake K, Larsen JP, Janvin C. Donepezil for cognitive impairment in Parkinson's disease: a randomised controlled study. J Neurol Neurosurg Psychiatry. 2002 Jun;72(6):708-12. doi: 10.1136/jnnp.72.6.708.

    PMID: 12023410BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseDementia

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Sangjin Kim, Professor

    Inje University Haeundae Paik Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangjin Kim, Professor

CONTACT

82-51-797-8736jsk120@hanmail.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Busan Paik Hospital, Inje University

Study Record Dates

First Submitted

March 14, 2015

First Posted

April 14, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2017

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

KR(1)