N/A
N=125
Intensive Instruction on the Use of Aricept
Alzheimer's Type Dementia
Bottom Line
View on ClinicalTrials.gov: NCT01972204 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants With Medication Continuation — 36; 39 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intensive adherence instruction (Behavioral); Control (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Mirai Iryo Research Center, Inc.
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Medication Continuation |
36; 39 | — |
| SECONDARY Reasons for Discontinuation |
17; 11; 2; 4; 3; 5 | — |
| SECONDARY Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics |
5; 7 | — |
| SECONDARY Adverse Events |
33; 23 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01972204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.