Alzheimer's DiseasePhase 3NCT00096473
Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease
A Phase 3 study testing Donepezil hydrochloride in people with Alzheimer's Disease and Dementia, run by Eisai Inc. at 42 sites in 6 countries.
Trial summary
Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- Donepezil hydrochloride
- How many people
- 229 participants
- Where
- 42 sitesin 6 countries
- Study dates
- Jan 2001to Sep 2005
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed Alzheimer's Disease with MMSE score 1~12
- Have not been treated by any medication for Alzheimer's Disease in past 3 months
- Live in community or Assisted Living Facility
- Healthy or with chronic diseases that are medically controlled or stabilized
- Able to swallow tablets
Who cannot join
- Any primary neurological or psychiatric diagnosis (including depressive disorder) other than Alzheimer's Disease
- Dementia caused by organic diseases other than Alzheimer's Disease
Trial locations and contacts
42 sites in 6 countries.
42 sites in 6 countries
United States28 sites
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Centerville, Ohio
Study site
Chicago, Illinois
Study site
Denver, Colorado
Study site
Fort Lauderdale, Florida
Study site
Fort Myers, Florida
Study site
Greenville, North Carolina
Study site
Houston, Texas
Study site
Jenkintown, Pennsylvania
Study site
Long Branch, New Jersey
Study site
Medford, Oregon
Study site
New Hyde Park, New York
Study site
New Orleans, Louisiana
Study site
North Miami, Florida
Study site
Northport, Alabama
Study site
Oklahoma City, Oklahoma
Study site
Phoenix, Arizona
Study site
Piscataway, New Jersey
Study site
Portland, Oregon
Study site
Raleigh, North Carolina
Study site
San Francisco, California
Study site
Santa Monica, California
Study site
Springfield, Massachusetts
Study site
St. Petersburg, Florida
Study site
Sun City, Arizona
Study site
Torrance, California
Study site
Tucson, Arizona
United Kingdom6 sites
Study site
Bath
Study site
Blackpool
Study site
Bradford
Study site
Saint Leonards-on-Sea, East Sussex
Study site
Swindon, Wilshire
Study site
West End, Southampton
Australia5 sites
Study site
Brisbane, Queensland
Study site
Heidelberg West, Victoria
Study site
Nedlands, Western Australia
Study site
Randwick, New South Wales
Study site
Woodville South, South Australia
About this study
Official title: A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period
Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. The purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe Alzheimer's disease.
Donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. This chemical helps a person's memory to work better.
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- Donepezil hydrochloride
- Keywords
- Alzheimer's Disease, dementia, acetylcholinesterase, donepezil, Aricept, memory loss, Severe dementia of the Alzheimer's type
- Medical subject headings
- Alzheimer Disease, Dementia, Pain, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil hydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessments of global and cognitive function of Severe AD patients
Secondary outcomes (2)
Assessment of behavior and performance on Activity of Daily Living in severe AD patients
Assessment of caregiver burden
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2004 (estimated)
- Study startJan 2001
- Primary completionJun 2005
- Study completionSep 2005
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.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Investigators
- Sharon Richardson, Ph.D., Study director, Eisai Inc.Honglan Li, Ph.D., Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096473
- Sponsor's protocol ID
- E2020-A001-315
- Status last verified
- Mar 2011
- First submitted
- 9 Nov 2004
- Last updated
- 1 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period
- ClinicalTrials.gov ID
- NCT00096473
- Acronym / sponsor ID
- E2020-A001-315
- Conditions
- Alzheimer's Disease, Dementia
- Keywords
- Alzheimer's Disease, dementia, acetylcholinesterase, donepezil, Aricept, memory loss, Severe dementia of the Alzheimer's type
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jan 2001
- Primary completion
- Jun 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 10 Nov 2004 (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.
Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. The purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe Alzheimer's disease.
Donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. This chemical helps a person's memory to work better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically diagnosed Alzheimer's Disease with MMSE score 1~12
- Have not been treated by any medication for Alzheimer's Disease in past 3 months
- Live in community or Assisted Living Facility
- Healthy or with chronic diseases that are medically controlled or stabilized
- Able to swallow tablets
Key exclusion criteria (2 listed)
- Any primary neurological or psychiatric diagnosis (including depressive disorder) other than Alzheimer's Disease
- Dementia caused by organic diseases other than Alzheimer's Disease
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 hydrochloride | Drug | – |
Primary outcome
Assessments of global and cognitive function of Severe AD patients
2 secondary outcomes
Assessment of behavior and performance on Activity of Daily Living in severe AD patients
Assessment of caregiver burden
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 1 Apr 2011.
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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.
Sharon Richardson, Ph.D. study director
Eisai Inc.
Honglan Li, Ph.D. study director
Eisai Inc.
42 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Donepezil hydrochloride in people with Alzheimer's Disease and Dementia, run by Eisai Inc. at 42 sites in 6 countries.
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 5 inclusion and 2 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 1 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, United Kingdom, Australia, Canada, France and 1 more country. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessments of global and cognitive function of Severe AD patients. 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 1 Apr 2011.