Dementia With Lewy Body DiseaseNCT02448784
Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies (DLB).
An observational study of Dementia With Lewy Body Disease, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil hydrochloride in clinical practice as well as its proper use information in participants with DLB. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia With Lewy Body Disease
- What is being tested?
- Donepezil Hydrochloride
- Type of treatment
- Pill or oral medicine
- How many people
- 591 participants
- Where
- 1 siteJapan
- Study dates
- 20 Apr 2015to 30 Mar 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Naive participants diagnosed as Dementia with Lewy bodies and administrated Aricept (donepezil hydrochloride)
Who may be able to join
- 1. Naive participants diagnosed as DLB
Who cannot join
- Participants with a history of donepezil hydrochloride product administration in the past
- Participants who have already been registered in this surveillance
- Participants with a history of hypersensitivity to any ingredients of donepezil hydrochloride or piperidine derivatives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies.
To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil hydrochloride in clinical practice as well as its proper use information in participants with DLB.
- Conditions
- Dementia With Lewy Body Disease
- Being tested
- Donepezil Hydrochloride
- Keywords
- Donepezil Hydrochloride, ARICEPT, Dementia, Lewy bodies, Dementia with Lewy bodies, Post-marketing surveillance
- Medical subject headings
- Dementia, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil HydrochlorideDrug
Also called Aricept
Initial dose for oral use is 3 mg once daily. The dose is increased to 5 mg after 1-2 weeks. Following at least 4 weeks of dosing at 5 mg, the dose is increased to 10 mg. The dose may be decreased to 5 mg depending on the symptoms of the participant.
| Study group | Role | What they receive |
|---|---|---|
| Participants with DLB | Participants with DLB who will receive donepezil hydrochloride per approved label. Receives: Drug: Donepezil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Mini-Mental State Examination (MMSE) score
Measured: At Week 12
Mean Mini-Mental State Examination (MMSE) score
Measured: At Week 24
Mean Mini-Mental State Examination (MMSE) score
Measured: At Week 52
Mean Revised Hasegawa's Dementia Scale (HDS-R) score
Measured: At Week 12
Mean Revised Hasegawa's Dementia Scale (HDS-R) score
Measured: At Week 24
Mean Revised Hasegawa's Dementia Scale (HDS-R) score
Measured: At Week 52
Secondary outcomes (1)
Number of participants with adverse events (AEs) /adverse drug reactions (ADRs)
Measured: From Week 0 to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study start20 Apr 2015
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Lewy Body 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kazuhiro Omata, Study director, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.Syoya Yamakawa, Study director, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448784
- Sponsor's protocol ID
- ART09T
- Status last verified
- Jan 2017
- First submitted
- 14 May 2015
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies.
- ClinicalTrials.gov ID
- NCT02448784
- Acronym / sponsor ID
- ART09T
- Conditions
- Dementia With Lewy Body Disease
- Keywords
- Donepezil Hydrochloride, ARICEPT, Dementia, Lewy bodies, Dementia with Lewy bodies, Post-marketing surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 19 May 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.
To investigate long term safety (especially about Parkinsonism) and efficacy of donepezil hydrochloride in clinical practice as well as its proper use information in participants with DLB.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with DLB | – | Drug: Donepezil HydrochlorideParticipants with DLB who will receive donepezil hydrochloride per approved label. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Naive participants diagnosed as Dementia with Lewy bodies and administrated Aricept (donepezil hydrochloride)
Key inclusion criteria (1 listed)
- 1. Naive participants diagnosed as DLB
Key exclusion criteria (3 listed)
- Participants with a history of donepezil hydrochloride product administration in the past
- Participants who have already been registered in this surveillance
- Participants with a history of hypersensitivity to any ingredients of donepezil hydrochloride or piperidine derivatives
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 |
|---|---|---|
| Donepezil HydrochlorideAlso: AriceptInitial dose for oral use is 3 mg once daily. The dose is increased to 5 mg after 1-2 weeks. Following at least 4 weeks of dosing at 5 mg, the dose is increased to 10 mg. The dose may be decreased to 5 mg depending on the symptoms of the participant. | Drug | Participants with DLB |
Primary outcome
Mean Mini-Mental State Examination (MMSE) score
Time frame: At Week 12
Mean Mini-Mental State Examination (MMSE) score
Time frame: At Week 24
Mean Mini-Mental State Examination (MMSE) score
Time frame: At Week 52
Mean Revised Hasegawa's Dementia Scale (HDS-R) score
Time frame: At Week 12
Mean Revised Hasegawa's Dementia Scale (HDS-R) score
Time frame: At Week 24
Mean Revised Hasegawa's Dementia Scale (HDS-R) score
Time frame: At Week 52
1 secondary outcome
Number of participants with adverse events (AEs) /adverse drug reactions (ADRs)
Time frame: From Week 0 to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
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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.
Kazuhiro Omata study director
Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
Syoya Yamakawa study director
Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia With Lewy Body Disease, run by Eisai Co., Ltd. at 1 site in Japan.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jul 2018. 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 Japan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Mini-Mental State Examination (MMSE) score (time frame: At Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2018.