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The purpose of this study is to examine the influence of the instruction on the use of Aricept with educational brochure on the 48-week medication persistence and to assess the reasons for discontinuation.
To examine the influence of the instruction on the use of Aricept with educational brochure comparing to the ordinary instruction on the 48-week medication persistence and to assess the reasons for discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive adherence instruction | Experimental | Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure |
|
| Control | Sham Comparator | The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive adherence instruction | Behavioral | Instruction with educational brochure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Medication Continuation | Number of Participants who Continue the Medication for 48 weeks | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for Discontinuation | Reasons for discontinuation of the Medication | 48 weeks |
| Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics | Number of Participants who descontinue the Clinical Trial Medication due to Change to Alicept (not for clinical trial) or Generics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tetsumasa Kamei | Shonan Fujisawa Tokushukai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shonan Fujisawa Tokushukai Hospital | Fujisawa | Kanagawa | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Adherence Instruction | Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure Intensive adherence instruction: Instruction with educational brochure |
| FG001 | Control | The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. Control: Instruction as per usual practice |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensive Adherence Instruction | Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure Intensive adherence instruction: Instruction with educational brochure |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Medication Continuation | Number of Participants who Continue the Medication for 48 weeks | Posted | Number | participants | 48 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intensive Adherence Instruction | Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure Intensive adherence instruction: Instruction with educational brochure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tomoko Machida (Director) | Mirai Iryo Research Center | 81-3-3263-4801 | machida@mirai-iryo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2013 | Feb 17, 2019 | Prot_SAP_000.pdf |
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| Control | Behavioral | Instruction as per usual practice |
|
| 48 weeks |
| Adverse Events | Adverse Events for each arm | Week 2, 12, 24, 48 |
The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. Control: Instruction as per usual practice |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Treatmnent for alzheimer's disease before study | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Reasons for Discontinuation | Reasons for discontinuation of the Medication | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
| Secondary | Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics | Number of Participants who descontinue the Clinical Trial Medication due to Change to Alicept (not for clinical trial) or Generics | Posted | Number | participants | 48 weeks |
|
|
|
| Secondary | Adverse Events | Adverse Events for each arm | Posted | Number | participants | Week 2, 12, 24, 48 |
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 20 |
| 58 |
| EG001 | Control | The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. Control: Instruction as per usual practice | 0 | 59 | 0 | 59 | 14 | 59 |
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| hypertention | Vascular disorders | Non-systematic Assessment |
|
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| Caretaker's wish |
|