Parkinson's DiseasePhase 2CUPIDNCT02415062
The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia
A Phase 2 study testing Donepezil in people with Parkinson's Disease, run by Inje University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Donepezil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inje university, busan paik hospital
Busan
Sang-jin kim, professor, 82-10-9525-6207, jsk120@hanmail.net
About this study
Official title: The Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With Dementia
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Donepezil
- Keywords
- Parkinson's disease, dementia
- Medical subject headings
- Parkinson Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Also called aricept
23mg/day for 24 weeks versus 10mg/day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| high dose donepezil (23mg) | Experimental | Patients with dementia in Parkinson's disease, who are treated with high dose donepezil (23mg) Receives: Drug: Donepezil |
| standard dose denepezil (10mg) | Active comparator | Patients with dementia in Parkinson's disease, who are treated with standard dose donepezil (10mg) Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Korean Mini-Mental State Examination-2 (MMSE-2)
scale for general cognitive function, We used Korean version of MMSE-2 from PAR company
Measured: 24 weeks
Secondary outcomes (9)
Korean-Instrumental Activities of Daily Living
scales for activities daily living
Measured: 24 weeks
Clinical dementia rating
scales for activities of daily living
Measured: 24 weeks
Unified Parkinson's disease rating scale (UPDRS) part 3
scales for motor symptoms in Parkinson's disease
Measured: 24 weeks
Modified Hoehn & Yahr stage
scales for status of Parkinson's disease
Measured: 24 weeks
Schwab & England Activities of Daily Living
scales for activities daily living
Measured: 24 weeks
Caregiver-Administered Neuropsychiatric Inventory
scales for status of caregiver
Measured: 24 weeks
Global Deterioration Scale
scales for activities of daily living
Measured: 24 weeks
Korean-Montreal Cognitive Assessment
scales for cognition
Measured: 24 weeks
Semantic fluency to evaluate neuropsychiatric symptoms
scales for language
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangjin Kim, Inje University
- Investigators
- Sangjin Kim, Professor, Principal investigator, Inje University Haeundae Paik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415062
- Sponsor's protocol ID
- CUPID-01
- Acronym
- CUPID
- Status last verified
- Aug 2015
- First submitted
- 14 Mar 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1136/jnnp.2004.050682.
PubMed 15965198Leroi 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.
PubMed 14716693Aarsland 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.
PubMed 12023410
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With Dementia
- ClinicalTrials.gov ID
- NCT02415062
- Acronym / sponsor ID
- CUPID / CUPID-01
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high dose donepezil (23mg) | Experimental | Drug: DonepezilPatients with dementia in Parkinson's disease, who are treated with high dose donepezil (23mg) |
| standard dose denepezil (10mg) | Active comparator | Drug: DonepezilPatients with dementia in Parkinson's disease, who are treated with standard dose donepezil (10mg) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonepezilAlso: aricept23mg/day for 24 weeks versus 10mg/day for 24 weeks | Drug | high dose donepezil (23mg), standard dose denepezil (10mg) |
Primary outcome
Korean Mini-Mental State Examination-2 (MMSE-2)
Time frame: 24 weeks
scale for general cognitive function, We used Korean version of MMSE-2 from PAR company
9 secondary outcomes
Korean-Instrumental Activities of Daily Living
Time frame: 24 weeks
Clinical dementia rating
Time frame: 24 weeks
Unified Parkinson's disease rating scale (UPDRS) part 3
Time frame: 24 weeks
Modified Hoehn & Yahr stage
Time frame: 24 weeks
Schwab & England Activities of Daily Living
Time frame: 24 weeks
Caregiver-Administered Neuropsychiatric Inventory
Time frame: 24 weeks
Global Deterioration Scale
Time frame: 24 weeks
Korean-Montreal Cognitive Assessment
Time frame: 24 weeks
Semantic fluency to evaluate neuropsychiatric symptoms
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Background: PubMed 15965198Ravina 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.
- Background: PubMed 14716693Leroi 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.
- Background: PubMed 12023410Aarsland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangjin Kim, Professor principal investigator
Inje University Haeundae Paik Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donepezil in people with Parkinson's Disease, run by Inje University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sangjin Kim, Professor (82-51-797-8736, jsk120@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Korean Mini-Mental State Examination-2 (MMSE-2) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02415062, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.