The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia
NCT ID: NCT02415062
Last Updated: 2015-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
150 participants
INTERVENTIONAL
2015-07-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
NCT05709301
Study to Evaluate DNL151 in Subjects With Parkinson's Disease
NCT04056689
A Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease Patients
NCT04220762
Comparison of the Incidence of Dyskinesia in Parkinson's Disease Who Were Treated With Amantadine or Dopamine Agonist
NCT01338662
PF 06412562 in Subjects With Advanced Stage Parkinson's Disease
NCT03665454
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
high dose donepezil (23mg)
Patients with dementia in Parkinson's disease, who are treated with high dose donepezil (23mg)
Donepezil
23mg/day for 24 weeks versus 10mg/day for 24 weeks
standard dose denepezil (10mg)
Patients with dementia in Parkinson's disease, who are treated with standard dose donepezil (10mg)
Donepezil
23mg/day for 24 weeks versus 10mg/day for 24 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Donepezil
23mg/day for 24 weeks versus 10mg/day for 24 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
Exclusion Criteria
* 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
50 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Inje University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sangjin Kim
Busan Paik Hospital, Inje University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sangjin Kim, Professor
Role: PRINCIPAL_INVESTIGATOR
Inje University Haeundae Paik Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Inje university, busan paik hospital
Busan, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CUPID-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.