Dementia With Lewy Bodies (DLB)Phase 2NCT00543855

A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)

A Phase 2 study testing 3 mg Donepezil hydrochloride, 5 mg Donepezil hydrochloride and 10 mg Donepezil hydrochloride in people with Dementia With Lewy Bodies (DLB), run by Eisai Co., Ltd. at 43 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of E2020 in patients with Dementia with Lewy Bodies (DLB). Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Dementia With Lewy Bodies (DLB)
What is being tested?: 3 mg Donepezil hydrochloride, 5 mg Donepezil hydrochloride and 10 mg Donepezil hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 167 participants
Where: 43 sitesJapan
Study dates: Nov 2007to Feb 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed as probable Dementia With Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
Participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution.

Who cannot join

Participants with past experience of donepezil (Aricept) therapy at the same study institution.
Participants treated with donepezil in 3 months immediately before starting the observation period.
Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency.
Participants with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.
Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion
Participants with severe extrapyramidal disorders (Hoehn \& Yahr staging score is ≥IV)
Participants whose systolic blood pressure is <90 mmHg or pulse rate is <50 beats/min.
Participants suspected to have a complication of vascular dementia based upon neurological findings.

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

Japan43 sites

Study site
Akita, Akita
Study site
Bunkyo-ku, Tokyo
Study site
Chiba, Chiba
Study site
Fukui-shi, Fukui
Study site
Fukuoka, Fukuoka
Study site
Himeji, Hyōgo
Study site
Izumo, Shimane
Study site
Jōetsu, Niigata
Study site
Jōyō, Kyoto
Study site
Kahoku, Ishikawa-ken
Study site
Kashihara, Nara
Study site
Kobe, Hyōgo
Study site
Kochi, Kochi
Study site
Kodaira, Tokyo
Study site
Komoro, Nagano
Study site
Kōshi, Kumamoto
Study site
Koto-ku, Tokyo
Study site
Kumamoto, Kumamoto
Study site
Kurume, Fukuoka
Study site
Kyoto, Kyoto
Study site
Maebashi, Gunma
Study site
Miyoshi, Hiroshima
Study site
Morioka, Iwate
Study site
Nagoya, Aichi-ken
Study site
Nankoku, Kochi
Study site
Ōbu, Aichi-ken
Study site
Omuta, Fukuoka
Study site
Osaka, Osaka
Study site
Ōta-ku, Tokyo
Study site
Ōtake, Hiroshima
Study site
Saitama, Saitama
Study site
Sakai, Osaka
Study site
Sanjō, Niigata
Study site
Sendai, Miyagi
Study site
Setagaya-ku, Tokyo
Study site
Shinjuku-ku, Tokyo
Study site
Shizuoka, Shizuoka
Study site
Suita, Osaka
Study site
Toyokawa, Aichi-ken
Study site
Tsukuba, Ibaraki
Study site
Ube, Yamaguchi
Study site
Yokohama, Kanagawa
Study site
Yufu, Oita Prefecture

Other trials in Japan

About this study

Official title: Double-blind Study of E2020 in Patients With Dementia With Lewy Bodies - Phase II

The purpose of this study is to evaluate the efficacy and safety of E2020 in patients with Dementia with Lewy Bodies (DLB).

Conditions: Dementia With Lewy Bodies (DLB)
Being tested: 3 mg Donepezil hydrochloride, 5 mg Donepezil hydrochloride, 10 mg Donepezil hydrochloride, Placebo
Keywords: Lewy Body Disease, Dementia, Clinical Trial, Phase II, E2020, donepezil hydrochloride
Medical subject headings: Lewy Body Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3 mg Donepezil hydrochlorideDrug
Also called Aricept, Donepezil hydrochloride, E2020
Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
5 mg Donepezil hydrochlorideDrug
Also called Aricept, Donepezil hydrochloride, E2020
Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
10 mg Donepezil hydrochlorideDrug
Also called Aricept, Donepezil hydrochloride, E2020
Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks).
PlaceboDrug
Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.

Study groups in NCT00543855
Study group	Role	What they receive
3 mg Donepezil hydrochloride	Experimental	Not described Receives: Drug: 3 mg Donepezil hydrochloride
5 mg Donepezil hydrochloride	Experimental	Not described Receives: Drug: 5 mg Donepezil hydrochloride
10 mg Donepezil hydrochloride	Experimental	Not described Receives: Drug: 10 mg Donepezil hydrochloride
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Measured: Baseline and every 4 weeks up to 12 weeks
Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)
NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated "worse neuropsychiatric outcomes." Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Measured: Baseline and every 4 weeks up to 12 weeks
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from "markedly improved" to "markedly worse". Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Measured: Baseline and week 12
Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)
J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia.
ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Feb 2010

First posted15 Oct 2007 (estimated)
Study startNov 2007
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00543855
Sponsor's protocol ID: E2020-J081-431
Status last verified: Mar 2013
First submitted: 4 Oct 2007
Last updated: 8 Mar 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Recruiting
Transcranial Alternating Current Stimulation in Lewy Body Dementia
Lewy Body Dementia (LBD), Transcranial Alternating Current Stimulation
RecruitingPhase 2
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Cognitive Dysfunction, Lewy Body Disease
RecruitingPhase 2
Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
RecruitingPhase 3
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis

All Dementia With Lewy Bodies (DLB) trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind Study of E2020 in Patients With Dementia With Lewy Bodies - Phase II
ClinicalTrials.gov ID: NCT00543855
Acronym / sponsor ID: E2020-J081-431
Conditions: Dementia With Lewy Bodies (DLB)
Keywords: Lewy Body Disease, Dementia, Clinical Trial, Phase II, E2020, donepezil hydrochloride
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 167 participants (actual)
Lead sponsor: Eisai Co., Ltd.Industry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 15 Oct 2007 (estimated)
Results: Posted 18 Feb 2013

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 the efficacy and safety of E2020 in patients with Dementia with Lewy Bodies (DLB).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
3 mg Donepezil hydrochloride	Experimental	Drug: 3 mg Donepezil hydrochloride
5 mg Donepezil hydrochloride	Experimental	Drug: 5 mg Donepezil hydrochloride
10 mg Donepezil hydrochloride	Experimental	Drug: 10 mg Donepezil hydrochloride
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients diagnosed as probable Dementia With Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
Participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution.

Key exclusion criteria (8 listed)

Participants with past experience of donepezil (Aricept) therapy at the same study institution.
Participants treated with donepezil in 3 months immediately before starting the observation period.
Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency.
Participants with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.
Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion

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
3 mg Donepezil hydrochlorideAlso: Aricept, Donepezil hydrochloride, E2020Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.	Drug	3 mg Donepezil hydrochloride
5 mg Donepezil hydrochlorideAlso: Aricept, Donepezil hydrochloride, E2020Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).	Drug	5 mg Donepezil hydrochloride
10 mg Donepezil hydrochlorideAlso: Aricept, Donepezil hydrochloride, E2020Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks). Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks). Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks).	Drug	10 mg Donepezil hydrochloride
PlaceboObservation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks. Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.	Drug	Placebo

Primary outcome

Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)
Time frame: Baseline and every 4 weeks up to 12 weeks
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)
Time frame: Baseline and every 4 weeks up to 12 weeks
NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated "worse neuropsychiatric outcomes." Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
Time frame: Baseline and week 12
CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from "markedly improved" to "markedly worse". Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)
Time frame: Baseline and Week 12
J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia. ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.

Results and safety

Results posted to the registry on 18 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3 mg Donepezil Hydrochloride	35	31
5 mg Donepezil Hydrochloride	33	31
10 mg Donepezil Hydrochloride	37	31
Placebo	34	30

Primary outcome: Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)

Time frame: Baseline and every 4 weeks up to 12 weeks. Mean (Standard Deviation). Unit: Score on a scale

Measure	3 mg Donepezil Hydrochloride n = 33	5 mg Donepezil Hydrochloride n = 31	10 mg Donepezil Hydrochloride n = 33	Placebo n = 30
Baseline	20.1 (4.2)	19.7 (4.4)	19.7 (4.5)	18.2 (4.8)
Change from Baseline (LOCF)	1.2 (3.8)	3.5 (3.2)	2.3 (3.2)	-0.6 (2.7)

Population analysed: Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.

Primary outcome: Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)

Time frame: Baseline and every 4 weeks up to 12 weeks. Mean (Standard Deviation). Unit: Score on a scale

Measure	3 mg Donepezil Hydrochloride n = 33	5 mg Donepezil Hydrochloride n = 31	10 mg Donepezil Hydrochloride n = 33	Placebo n = 30
Baseline	20.9 (13.1)	14.2 (8.4)	19.1 (11.8)	18.4 (8.9)
Change from Baseline (LOCF)	-4.3 (21.5)	-5.9 (6.5)	-10.2 (12.0)	-3.1 (10.9)

Population analysed: Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.

Primary outcome: Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)

Time frame: Baseline and week 12. Number. Unit: Percentage of Participants

Measure	3 mg Donepezil Hydrochloride n = 33	5 mg Donepezil Hydrochloride n = 31	10 mg Donepezil Hydrochloride n = 33	Placebo n = 30
Marked improvement	3.6	17.9	3.8	0
Moderate Improvement	17.9	17.9	11.5	3.7
Minimal Improvement	50.0	35.7	50.0	29.6
No Change	21.4	14.3	30.8	18.5
Minimal Worsening	3.6	7.1	3.8	37.0
Moderate Worsening	0	7.1	0	11.1
Marked Worsening	3.6	0	0	0

Population analysed: Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.

Primary outcome: Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: Score on a scale

Measure	3 mg Donepezil Hydrochloride n = 33	5 mg Donepezil Hydrochloride n = 31	10 mg Donepezil Hydrochloride n = 33	Placebo n = 30
Baseline	28.3 (14.4)	23.2 (11.6)	26.9 (16.3)	22.3 (9.8)
Change from Baseline (LOCF)	-1.3 (11.1)	-0.6 (16.4)	-5.2 (13.8)	2.9 (9.1)

Population analysed: Per Protocol Set (PPS) was defined as those participants who complied with the study protocol.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3 mg Donepezil Hydrochloride	2 of 35 (5.7%)	24 of 35 (68.6%)	Not reported
5 mg Donepezil Hydrochloride	2 of 33 (6.1%)	27 of 33 (81.8%)	Not reported
10 mg Donepezil Hydrochloride	4 of 37 (10.8%)	32 of 37 (86.5%)	Not reported
Placebo	2 of 34 (5.9%)	24 of 34 (70.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dementia With Lewy Bodies (DLB)

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Recruiting
Transcranial Alternating Current Stimulation in Lewy Body Dementia
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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.

Masaki Nakagawa study director

Neurosciences Clinical Development Section, Japan / Asia Clinical Research, Product Creation Unit, Eisai Product Creation System.

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 8 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 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 18 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) (time frame: Baseline and every 4 weeks up to 12 weeks). The study lists 4 primary outcomes in all. 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 NCT00543855.

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 8 Mar 2013.