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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01972204
- Acronym / sponsor ID
- ART-2013-01
- Conditions
- Alzheimer's Type Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Mirai Iryo Research Center, Inc.University, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 30 Oct 2013 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive adherence instruction | Experimental | Behavioral: Intensive adherence instructionIntensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure |
| Control | Sham comparator | Behavioral: ControlThe control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive adherence instructionInstruction with educational brochure | Behavioural | Intensive adherence instruction |
| ControlInstruction as per usual practice | Behavioural | Control |
Primary outcome
Number of Participants With Medication Continuation
Time frame: 48 weeks
Number of Participants who Continue the Medication for 48 weeks
3 secondary outcomes
Reasons for Discontinuation
Time frame: 48 weeks
Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics
Time frame: 48 weeks
Adverse Events
Time frame: Week 2, 12, 24, 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tetsumasa Kamei principal investigator
Shonan Fujisawa Tokushukai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Medication Continuation (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.