Alzheimer's Type DementiaNCT01972204
Intensive Instruction on the Use of Aricept
A study testing Intensive adherence instruction in people with Alzheimer's Type Dementia, run by Mirai Iryo Research Center, Inc. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Type Dementia
- What is being tested?
- Intensive adherence instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2013to Aug 2017
- Phase
- Interventional
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study About the Impact of Intensive Instruction on the Use of Aricept and the Reasons for Discontinuation in Patients With Alzheimer's Disease
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.
Read the 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.
- Conditions
- Alzheimer's Type Dementia
- Being tested
- Intensive adherence instruction, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive adherence instructionBehavioural
Instruction with educational brochure
ControlBehavioural
Instruction as per usual practice
| Study group | Role | What they receive |
|---|---|---|
| Intensive adherence instruction | Experimental | Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure Receives: Behavioral: Intensive adherence instruction |
| Control | Sham comparator | The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Medication Continuation
Number of Participants who Continue the Medication for 48 weeks
Measured: 48 weeks
Secondary outcomes (3)
Reasons for Discontinuation
Reasons for discontinuation of the Medication
Measured: 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
Measured: 48 weeks
Adverse Events
Adverse Events for each arm
Measured: Week 2, 12, 24, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2017
- Study completionAug 2017
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 Alzheimer's Type DementiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirai Iryo Research Center, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tetsumasa Kamei, Mirai Iryo Research Center, Inc.
- Investigators
- Tetsumasa Kamei, Principal investigator, Shonan Fujisawa Tokushukai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972204
- Sponsor's protocol ID
- ART-2013-01
- Status last verified
- Feb 2019
- First submitted
- 24 Oct 2013
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov