Dementia With Lewy Bodies (DLB)NCT00776347
Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
A study testing Donepezil in people with Dementia With Lewy Bodies (DLB), run by Osaka University at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate change of cerebral glucose metabolism by donepezil therapy and to associate change of glucose metabolism and symptoms. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia With Lewy Bodies (DLB)
- What is being tested?
- Donepezil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2008to Feb 2015
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DLB patients:
- who fulfill the diagnostic criteria of DLB
- 60 to 85 years old
- right-handed
- Clinical Dementia Rating (CDR) ≧ 0.5
- Mini Mental State Examination (MMSE) score from 10 to 26
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- Normal Controls:
- who are independent
- who have no subjective or objective cognitive impairment
- 60 to 85 years old
- right-handed
- MMSE score over 24
Who cannot join
- DLB patients:
- who have diabetes mellitus
- who have pathological change on MRI other than brain atrophy
- who have complication or history of dementia other than DLB, psychiatric disease, and physical disorder that affect brain function
- who have severe complication of cardiovascular, hepatic, renal, or other diseases unable to secure the safety
- who have severe digestive ulcus
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- who have severe bronchitic asthma or obstructive lung disease
- who have no caregiver who knows patient's condition well
- Normal Controls:
- who have diabetes mellitus
- who have taken donepezil before
- who have abnormal findings on MRI
- who have complication or history of brain injury, psychiatric disease, and physical disorder that affect brain function
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate change of cerebral glucose metabolism by donepezil therapy and to associate change of glucose metabolism and symptoms.
- Conditions
- Dementia With Lewy Bodies (DLB)
- Being tested
- Donepezil
- Keywords
- Dementia with Lewy bodies (DLB), FDG-PET
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Dosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks
DonepezilDrug
| Study group | Role | What they receive |
|---|---|---|
| donepezil | Experimental | Not described Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDG-PET
Measured: 14 weeks
Secondary outcomes (1)
Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia With Lewy Bodies (DLB)Studies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroaki Kazui, Osaka University
- Investigators
- Hiroaki Kazui, MD, PhD, Principal investigator, Osaka University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776347
- Sponsor's protocol ID
- OSK-08096
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2008
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kanemoto H, Kazui H, Adachi H, Yoshiyama K, Wada T, Nomura KT, Shimosegawa E, Ikeda M. Thalamic pulvinar metabolism, sleep disturbances, and hallucinations in dementia with Lewy bodies: Positron emission tomography and actigraphy study. Int J Geriatr Psychiatry. 2020 Aug;35(8):934-943. doi: 10.1002/gps.5315. Epub 2020 Jun 8.
PubMed 32346907
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)
- ClinicalTrials.gov ID
- NCT00776347
- Acronym / sponsor ID
- OSK-08096
- Conditions
- Dementia With Lewy Bodies (DLB)
- Keywords
- Dementia with Lewy bodies (DLB), FDG-PET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Oct 2008 (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 is to evaluate change of cerebral glucose metabolism by donepezil therapy and to associate change of glucose metabolism and symptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| donepezil | Experimental | Drug: Donepezil |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- who fulfill the diagnostic criteria of DLB
- 60 to 85 years old
- right-handed
- Clinical Dementia Rating (CDR) ≧ 0.5
- Mini Mental State Examination (MMSE) score from 10 to 26
Key exclusion criteria (13 listed)
- who have diabetes mellitus
- who have pathological change on MRI other than brain atrophy
- who have complication or history of dementia other than DLB, psychiatric disease, and physical disorder that affect brain function
- who have severe complication of cardiovascular, hepatic, renal, or other diseases unable to secure the safety
- who have severe digestive ulcus
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 |
|---|---|---|
| DonepezilDosage: 3mg PO/day for the first 2 weeks and 5mg PO/day for the next 14 weeks Duration: 16 weeks | Drug | donepezil |
| Donepezil | Drug | donepezil |
Primary outcome
FDG-PET
Time frame: 14 weeks
1 secondary outcome
Cognitive function, psychiatric symptoms, global clinical function, and burden of caregiver
Time frame: 14 weeks
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 15 Oct 2015.
- Derived from this study: PubMed 32346907Kanemoto H, Kazui H, Adachi H, Yoshiyama K, Wada T, Nomura KT, Shimosegawa E, Ikeda M. Thalamic pulvinar metabolism, sleep disturbances, and hallucinations in dementia with Lewy bodies: Positron emission tomography and actigraphy study. Int J Geriatr Psychiatry. 2020 Aug;35(8):934-943. doi: 10.1002/gps.5315. Epub 2020 Jun 8.
- Related InfoLink provided by the sponsor.
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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.
Hiroaki Kazui, MD, PhD principal investigator
Osaka University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donepezil in people with Dementia With Lewy Bodies (DLB), run by Osaka University 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 12 inclusion and 13 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 15 Oct 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 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?
FDG-PET (time frame: 14 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 NCT00776347, which also lists 1 linked publication.
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 15 Oct 2015.