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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010778
Receipt No. R000012611
Scientific Title Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1
Date of disclosure of the study information 2013/05/22
Last modified on 2020/09/07

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Basic information
Public title Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1
Acronym EDAP-2
Scientific Title Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1
Scientific Title:Acronym EDAP-2
Region
Japan

Condition
Condition Parkinson disease
Classification by specialty
Medicine in general Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of donepezil hydrocloride against cognitive decline in patients who completed EDAP-1, by delayed start paradigm.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of MMSE scores at the last visit from the basline scores of EDAP-1
Key secondary outcomes Changes of Parkinson Psychosis Questionaire, Frontal Assessment Battery, and WMS-R from the baseline scores of EDAP-1

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 5mg donepezil hydrocloride
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Participants of EDAP-1 in Utano National Hosptial who have completed EDAP-1.
2. Both in-patients and out-patients.
3. Both females and males.
4. Age of 20 or elder (at IC obtaining)
5. Patients who give written informed consent.
6. Patients who are able to follow the study principles and to report their symptoms.
Key exclusion criteria 1. Past use of donepezil hydrochloride.
2. Use of an inhibitor of brain acetylcholine esterase (listed in the protocol) in the 4 weeks before Visit 2.
3.Patients who are diagnosed as possible or probable diffuse Lewy body disease according to the diagnostic criteria (shown in the protocol).
4.. Patients who have been diagnosed as schizophrenia.
5. Patients with previous history of the stereotaxic brain operation.
6. Patients with allergy to pyperidium derivatives.
7. Severe hepatic or renal dysfunction.
8. Patients with sick sinus syndrome or intra-atrial or AV nodal block (such as SA block or AV block of grade II or severer).
9. Patients with present or previous illness of severe gastrointestinal ulcer, severe bronchial asthma, or obstructive pulmonary disease.
10. Bradycardia (heart rate: 45 /min or less.) in the ECG at Visit 1.
11. QT elongation (QTc: >460msec) in the ECG at Visit 1.
12. Patients who are pregnant or feeding a baby.
13.Patients who are diagnosed as having malignancy
14. Patients who are judged as inappropriate for the enrolling to the trial by investigators.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hideyuki
Middle name
Last name Sawada
Organization National Hospital of Utano
Division name Clinical Research Center
Zip code 616-8255
Address 8 Ondoyama-cho, Narutaki, Ukyoku, Kyoto
TEL 075-561-5121
Email sawada@unh.hosp.go.jp

Public contact
Name of contact person
1st name Hideyuki
Middle name
Last name Sawada
Organization National Hospital of Utano
Division name Clinical Research Center
Zip code 616-8255
Address 8 Ondoyama-cho, Narutaki, Ukyoku, Kyoto
TEL 075-461-5121
Homepage URL
Email sawada.unh@gmail.com

Sponsor
Institute National Hospital of Utano
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hopsital Organization, Utano National Hospital
Address 8 Ondoyamacho, Narutaki, Ukyoku, Kyoto
Tel 81-75-461-5121
Email sawada.unh@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 22 Day

Related information
URL releasing protocol https://www.tandfonline.com/doi/abs/10.1080/14656566.2020.1814255
Publication of results Published

Result
URL related to results and publications https://www.tandfonline.com/doi/abs/10.1080/14656566.2020.1814255
Number of participants that the trial has enrolled 98
Results MMSE change at week 120 was better in the
early-start group than in the delayed-start
group, but the difference was not
significant. The MMSE declined in
apolipoprotein e4 carriers, but not in
non-carriers, and the factor interaction
(intervention x e4 genotype) was highly
significant (P < 0.001). Analyzed with the
interaction, the difference was significant (group difference 1.95 [0.33 to 3.57], P = 0.018).
Results date posted
2020 Year 09 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The demographic and clinical features of the two groups were similar. Dopamine is associated with cognitive motivation in Parkinson disease 25. The dose of dopamine replacement therapy is shown in Table 1, and it was similar between the early-start and delayed-start groups. The mean (SD) baseline MMSE was 27.6 (2.0) in the early-start group and 28.0 (2.1) in the delayed-start group, and the percentage of apolipoprotein e4 carriers was 27.1% and 26.0%, respectively.
Participant flow A total of 137 eligible patients were invited to participate in phase 1, and 108 patients gave consent between 1 April 2011 and 28 March 2012. Excluding 10 patients who were found to be ineligible, 98 patients were randomized to early-start (donepezil-to-donepezil, 48 patients) and delayed-start (placebo-to-donepezil, 50 patients) groups. Among the 48 patients in the early-start group, 29 completed phase 1, and 25 gave consent to phase 2. Among the 50 patients in the delayed-start group, 36 completed phase 1, and 23 gave consent to phase 2. In phase 2, five patients were discontinued due to consent withdrawal (three patients in the early-start and two patients in the delayed groups) and the data of 43 patients (22 in the early-start and 23 in the delayed-start) were analyzed with the intention-to-treat principle for the primary outcome measure.
Adverse events The most common adverse events in phase 2 were hallucinations (12 events) and delusions (4 events), and the prevalence was higher in the early-start group than in the delayed-start group.
Outcome measures In the early-start group, MMSE scores were stable in phase 1 and slightly higher in phase 2. In contrast, the scores in the delayed-start group decreased gradually throughout phase 1 and slightly increased in phase 2 (Figure 2A). At the end of phase 1, the estimated change in MMSE was -0.45 (-1.69 to 0.80) and -1.87 (-2.88 to -0.87) in the early-start and placebo groups, and the estimated group difference (SEM) was 1.43 (0.82) (P = 0.081). The change in MMSE score at week 120 was better in the early-start group than in the delayed-start group; however, the difference was not statistically significant.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 02 Month 15 Day
Date of IRB
2013 Year 02 Month 21 Day
Anticipated trial start date
2013 Year 04 Month 10 Day
Last follow-up date
2014 Year 11 Month 10 Day
Date of closure to data entry
2014 Year 11 Month 30 Day
Date trial data considered complete
2014 Year 12 Month 10 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 22 Day
Last modified on
2020 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012611

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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