Alzheimer's DiseaseNCT01251718
Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease
An observational study of Alzheimer's Disease, run by Eisai Co., Ltd. at 106 sites in Japan.
Trial summary
To investigate the clinical safety and effectiveness of donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- donepezil hydrochloride
- Type of treatment
- Pill or oral medicine
- How many people
- 894 participants
- Where
- 106 sitesJapan
- Study dates
- 1 Dec 2010to 18 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Alzheimer's Disease
Who may be able to join
- Patients diagnosed as Alzheimer's Disease by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
- Patients diagnosed as mild or moderate Alzheimer's Disease, applicable to Functional Assessment Staging (FAST) score 4 or 5.
Who cannot join
- Patients who used Aricept within 3 months prior to dosing.
- Patients registered this survey before.
- Patients with a history of hypersensitivity to any ingredients of Aricept or piperidine derivatives.
Trial locations and contacts
106 sites in 1 country.
106 sites in 1 country
Japan106 sites
Study site
Adachi City, Tokyo
Study site
Aioi, Hyōgo
Study site
Akashi, Hyōgo
Study site
Akita
Study site
Amagasaki, Hyōgo
Study site
Anjo, Aichi-ken
Study site
Bunkyo, Tokyo
Study site
Chiba
Study site
Daisen, Akita
Study site
Ebina, Kanagawa
Study site
Fujioka, Gunma
Study site
Fukaya, Saitama
Study site
Fukuoka
Study site
Fukushima
Study site
Fukuyama, Hiroshima
Study site
Gifu
Study site
Hachiōji, Tokyo
Study site
Hagi, Yamaguchi
Study site
Hakodate, Hokkaido
Study site
Hamamatsu, Shizuoka
Study site
Hannō, Saitama
Study site
Himeji, Hyōgo
Study site
Hirosaki, Aomori
Study site
Hiroshima
Study site
Ichihara, Chiba
Study site
Iida, Nagano
Study site
Ikoma, Nara
Study site
Iruma, Saitama
Study site
Iwaki, Fukushima
Study site
Iyo, Ehime
Study site
Izumisano, Osaka
Study site
Kagoshima
Study site
Kaizuka, Osaka
Study site
Kanazawa, Ishikawa-ken
Study site
Kashihara, Nara
Study site
Kashiwa, Chiba
Study site
Katsushika-ku, Tokyo
Study site
Kawasaki, Kanagawa
Study site
Kinokawa, Wakayama
Study site
Kita, Kagawa-ken
Study site
Kitakyushu, Fukuoka
Study site
Kitamorokata, Miyazaki
Study site
Kobe, Hyōgo
Study site
Kochi
Study site
Koshigaya, Saitama
Study site
Kurashiki, Okayama-ken
Study site
Kurayoshi, Tottori
Study site
Kure, Hiroshima
Study site
Kyoto
Study site
Machida, Tokyo
Study site
Masuda, Shimane
Study site
Matsubara, Osaka
Study site
Matsumoto, Nagano
Study site
Matsuyama, Ehime
Study site
Meguro City, Tokyo
Study site
Minato, Tokyo
Study site
Mitoyo, Kagawa-ken
Study site
Miyoshi, Hiroshima
Study site
Mizunami, Gifu
Study site
Moriya, Ibaraki
Study site
Nagoya, Aichi-ken
Study site
Nakano City, Tokyo
Study site
Nankoku, Kochi
Study site
Nanto, Toyama
Study site
Nara
Study site
Nayoro, Hokkaido
Study site
Niigata
Study site
Niihama, Ehime
Study site
Obihiro, Hokkaido
Study site
Ōita
Study site
Okaya, Nagano
Study site
Okayama
Study site
Omuta, Fukuoka
Study site
Osaka
Study site
Ōtake, Hiroshima
Study site
Otaru, Hokkaido
Study site
Saiki, Oita Prefecture
Study site
Sakai, Osaka
Study site
Sakura, Chiba
Study site
Sapporo, Hokkaido
Study site
Sasebo, Nagasaki
Study site
Sayama, Osaka
Study site
Sayama, Saitama
Study site
Sendai, Miyagi
Study site
Setagaya City, Tokyo
Study site
Shinjuku, Tokyo
Study site
Shizuoka
Study site
Shūnan, Yamaguchi
Study site
Suita, Osaka
Study site
Sunagawa, Hokkaido
Study site
Suzuka, Mie-ken
Study site
tabashi City, Tokyo
Study site
Taitō City, Tokyo
Study site
Tendō, Yamagata
Study site
Tōon, Ehime
Study site
Toshima City, Tokyo
Study site
Towada, Aomori
Study site
Tsu, Mie-ken
Study site
Ube, Yamaguchi
Study site
Uji, Kyoto
Study site
Ukiha, Fukuoka
Study site
Yamanashi
Study site
Yokkaichi, Mie-ken
Study site
Yokohama, Kanagawa
Study site
Yokosuka, Kanagawa
Study site
Yufu, Oita Prefecture
About this study
Official title: Post-marketing Surveillance of Donepezil Hydrochloride- Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease
To investigate the clinical safety and effectiveness of donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Being tested
- donepezil hydrochloride
- Keywords
- Donepezil hydrochloride, Alzheimer's Disease
- 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
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 |
|---|---|---|
| Donepezil Hydrochloride | Not described Receives: Drug: donepezil hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-Jcog (test of cognitive function)
Measured: 36 month (12 weeks and every 6 months)
Secondary outcomes (1)
Adverse events/adverse drug reactions
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study start1 Dec 2010
- Primary completion14 Oct 2015
- Study completion18 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- 894 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shoya Yamakawa, Study director, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251718
- Sponsor's protocol ID
- ART06T
- Status last verified
- Jan 2017
- First submitted
- 1 Dec 2010
- Last updated
- 24 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance of Donepezil Hydrochloride- Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01251718
- Acronym / sponsor ID
- ART06T
- Conditions
- Alzheimer's Disease
- Keywords
- Donepezil hydrochloride, Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 894 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2010 (actual)
- Primary completion
- 14 Oct 2015 (actual)
- Study completion
- 18 Feb 2016 (actual)
- First posted
- 2 Dec 2010 (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 clinical safety and effectiveness of donepezil hydrochloride administration in patients with mild or moderate Alzheimer's Disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donepezil Hydrochloride | – | Drug: donepezil hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Alzheimer's Disease
Key inclusion criteria (2 listed)
- Patients diagnosed as Alzheimer's Disease by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
- Patients diagnosed as mild or moderate Alzheimer's Disease, applicable to Functional Assessment Staging (FAST) score 4 or 5.
Key exclusion criteria (3 listed)
- Patients who used Aricept within 3 months prior to dosing.
- Patients registered this survey before.
- 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 hydrochlorideInitial 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 | Donepezil Hydrochloride |
Primary outcome
ADAS-Jcog (test of cognitive function)
Time frame: 36 month (12 weeks and every 6 months)
1 secondary outcome
Adverse events/adverse drug reactions
Time frame: 36 months
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 24 Jul 2023.
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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.
Shoya Yamakawa study director
Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
106 sites 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 Disease, run by Eisai Co., Ltd. at 106 sites 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 2 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites 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?
ADAS-Jcog (test of cognitive function) (time frame: 36 month (12 weeks and every 6 months)). 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 24 Jul 2023.