Alzheimer's DeseaseNCT02162251
Post-marketing Surveillance of Donepezil Hydrochloride Investigation of the Safety and Effectiveness of Combination Therapy of Donepezil Hydrochloride and Memantine Hydrochloride in Patients With Alzheimer's Disease
An observational study of Alzheimer's Desease, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
To investigate the safety and effectiveness about administration of both donepezil hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Desease
- What is being tested?
- Donepezil Hydrochloride
- Type of treatment
- Pill or oral medicine
- How many people
- 3,482 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jun 2013to 15 Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with Alzheimer's Disease
Who may be able to join
- Patients diagnosed with Alzheimer's Disease who are to be administered both donepezil hydrochloride and memantine hydrochloride in clinical practice.
Who cannot join
- Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the safety and effectiveness about administration of both donepezil hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical practice.
- Conditions
- Alzheimer's Desease
- Being tested
- Donepezil Hydrochloride
- Keywords
- Alzheimer's Disease, donepezil hydrochloride
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil HydrochlorideDrug
Also called Aricept
Initial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms.
| Study group | Role | What they receive |
|---|---|---|
| E2020 | Not described Receives: Drug: Donepezil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigations on adverse events and adverse drug reactions
Measured: Up to 12 months
Secondary outcomes (2)
Severity of dementia based on the Functional Assessment Staging Test (FAST)
FAST is a seven stage system based on level of functioning and daily activities. It focuses more on an individual's level of functioning and activities of daily living versus cognitive decline
Measured: Baseline, Month 3, Month 6, and Month 12
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
The MMSE is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening.
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study start1 Jun 2013
- Primary completion1 May 2015
- Study completion15 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DeseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162251
- Sponsor's protocol ID
- ART07T
- Status last verified
- Dec 2016
- First submitted
- 10 Jun 2014
- Last updated
- 7 Sep 2018
- Results posted
- No
Publications
Geriatric Medicine 55(1): 87-100, 2017.
Geriatric Medicine 55(11): 1251-1264, 2017.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance of Donepezil Hydrochloride Investigation of the Safety and Effectiveness of Combination Therapy of Donepezil Hydrochloride and Memantine Hydrochloride in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02162251
- Acronym / sponsor ID
- ART07T
- Conditions
- Alzheimer's Desease
- Keywords
- Alzheimer's Disease, donepezil hydrochloride
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,482 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 15 Apr 2016 (actual)
- First posted
- 12 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety and effectiveness about administration of both donepezil hydrochloride and menatine hydrochloride in patients with Alzheimer's Disease in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E2020 | – | Drug: Donepezil Hydrochloride |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Alzheimer's Disease
Key inclusion criteria (1 listed)
- Patients diagnosed with Alzheimer's Disease who are to be administered both donepezil hydrochloride and memantine hydrochloride in clinical practice.
Key exclusion criteria (1 listed)
- Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.
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 |
|---|---|---|
| Donepezil HydrochlorideAlso: AriceptInitial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms. | Drug | E2020 |
Primary outcome
Investigations on adverse events and adverse drug reactions
Time frame: Up to 12 months
2 secondary outcomes
Severity of dementia based on the Functional Assessment Staging Test (FAST)
Time frame: Baseline, Month 3, Month 6, and Month 12
Change From Baseline in the Mini-Mental State Examination (MMSE) Score
Time frame: Baseline and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Results publicationGeriatric Medicine 55(1): 87-100, 2017.
- Results publicationGeriatric Medicine 55(11): 1251-1264, 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Desease, run by Eisai Co., Ltd. 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 1 inclusion and 1 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 7 Sep 2018. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Investigations on adverse events and adverse drug reactions (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02162251, which also lists 2 linked publications.
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 7 Sep 2018.