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The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia

Information source: Inje University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson's Disease

Intervention: Donepezil (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Inje University

Official(s) and/or principal investigator(s):
Sangjin Kim, Professor, Principal Investigator, Affiliation: Inje University

Overall contact:
Sangjin Kim, Professor, Phone: 82-51-797-8736, Email: jsk120@hanmail.net

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.

Clinical Details

Official title: The Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With Dementia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Korean Mini-Mental State Examination-2 (MMSE-2)

Secondary outcome:

Korean-Instrumental Activities of Daily Living

Clinical dementia rating

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

Modified Hoehn & Yahr stage

Schwab & England Activities of Daily Living

Caregiver-Administered Neuropsychiatric Inventory

Global Deterioration Scale

Korean-Montreal Cognitive Assessment

Semantic fluency to evaluate neuropsychiatric symptoms

Detailed description: This study is open-label, prospective, randomized paralleled study. The investigators evaluate the efficacy of high-dose donepezil in patients with Parkinson's disease with dementia (PDD) who have taken standard donepezil (10mg) for 12 weeks. The participants, who sign the informed consent, are assigned into two groups randomly (high-dose donepezil group and standard donepezil group). All participants will be maintained the medication for 24 weeks and assessed cognitive function at 24 weeks. They will visit to clinic for 3 times (4, 12, 24 weeks) to assess cognitive function and adverse event. After the end of study, all participants were administrated by standard dose donepezil again.

Eligibility

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion criteria :

- 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

Exclusion criteria :

- 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

Locations and Contacts

Sangjin Kim, Professor, Phone: 82-51-797-8736, Email: jsk120@hanmail.net

Inje university, busan paik hospital, Busan, Korea, Republic of; Recruiting
Sang-jin kim, professor, Phone: 82-10-9525-6207, Email: jsk120@hanmail.net
Additional Information

Related publications:

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.

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.

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. Erratum in: J Neurol Neurosurg Psychiatry 2002 Sep;73(3):354.

Starting date: July 2015
Last updated: August 5, 2015

Page last updated: August 20, 2015

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