Alzheimer's Type Dementia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALIntensive adherence instruction
Instruction with educational brochure
BEHAVIORALControl
Instruction as per usual practice
Sponsors
Mirai Iryo Research Center, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnostic evidence of probable Alzheimer's type Dementia consistent with DSM-IV. * Written informed consent will be obtained from subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities. * Patients having caregivers who submit written consent for cooperative involvement in this study, can provide patients' information necessary for this study, assist treatment compliance, and escort patients on required visits to study institution. * Outpatients in their own home.
Exclusion criteria
* Patients treated with donepezil, galantamine, rivastigmine in 4 weeks immediately before enrollment. * Known hypersensitivity to donepezil or piperidine derivatives. * Involvement in any other investigational drug clinical trail during the preceding 12 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Medication Continuation | 48 weeks | Number of Participants who Continue the Medication for 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for Discontinuation | 48 weeks | Reasons for discontinuation of the Medication |
| Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics | 48 weeks | Number of Participants who descontinue the Clinical Trial Medication due to Change to Alicept (not for clinical trial) or Generics |
| Adverse Events | Week 2, 12, 24, 48 | Adverse Events for each arm |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 58 |
| 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 | 59 |
| Total | 117 |
Baseline characteristics
| Characteristic | Intensive Adherence Instruction | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 58 Participants | 58 Participants | 116 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Continuous | 79.7 years STANDARD_DEVIATION 7.23 | 80.2 years STANDARD_DEVIATION 6.99 | 79.9 years STANDARD_DEVIATION 7.08 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 58 Participants | 59 Participants | 117 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 58 Participants | 59 Participants | 117 Participants |
| Sex: Female, Male Female | 37 Participants | 31 Participants | 68 Participants |
| Sex: Female, Male Male | 21 Participants | 28 Participants | 49 Participants |
| Treatmnent for alzheimer's disease before study | 44 participants | 48 participants | 92 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 59 |
| other Total, other adverse events | 20 / 58 | 14 / 59 |
| serious Total, serious adverse events | 0 / 58 | 0 / 59 |
Outcome results
Primary
Number of Participants With Medication Continuation
Number of Participants who Continue the Medication for 48 weeks
Time frame: 48 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Adherence Instruction | Number of Participants With Medication Continuation | 36 participants |
| Control | Number of Participants With Medication Continuation | 39 participants |
Secondary
Adverse Events
Adverse Events for each arm
Time frame: Week 2, 12, 24, 48
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Adherence Instruction | Adverse Events | 33 participants |
| Control | Adverse Events | 23 participants |
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
Time frame: 48 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive Adherence Instruction | Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics | 5 participants |
| Control | Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics | 7 participants |
Secondary
Reasons for Discontinuation
Reasons for discontinuation of the Medication
Time frame: 48 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intensive Adherence Instruction | Reasons for Discontinuation | Pysician's decision | 17 Participants |
| Intensive Adherence Instruction | Reasons for Discontinuation | Participant's wish | 2 Participants |
| Intensive Adherence Instruction | Reasons for Discontinuation | Caretaker's wish | 3 Participants |
| Control | Reasons for Discontinuation | Pysician's decision | 11 Participants |
| Control | Reasons for Discontinuation | Participant's wish | 4 Participants |
| Control | Reasons for Discontinuation | Caretaker's wish | 5 Participants |