Memory LossPhase 4NCT00293176
The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
A Phase 4 study testing Donepezil Hydrochloride in people with Memory Loss, run by Eisai Inc. at 54 sites in United States.
Trial summary
To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Memory Loss
- What is being tested?
- Donepezil Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 821 participants
- Where
- 54 sitesUnited States
- Study dates
- Dec 2003to Mar 2007
- Phase
- Phase 4
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Memory complaint
- Mini Mental Status Exam (MMSE) score 24-28 inclusive
- General cognition and function performance sufficiently preserved such that a diagnosis of Alzheimer's disease (AD) cannot be made
- Generally healthy and ambulatory
- Sufficiently fluent in English
Who cannot join
- Diagnosis of probable or possible AD
- Neurological disorders
- History of malignant cancers
- Previously have taken donepezil or other acetylcholinesterase (ChE) inhibitors for more than 1 month or in the past 3 months prior to study entry
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
United States54 sites
Study site
Albany, New York
Study site
Albaster, Alabama
Study site
Bennington, Vermont
Study site
Boynton Beach, Florida
Study site
Centerville, Ohio
Study site
Charlottesville, Virginia
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Denver, Colorado
Study site
Elkhart, Indiana
Study site
Farmington Hills, Michigan
Study site
Fort Meyers, Florida
Study site
Fresno, California
Study site
Garden Grove, California
Study site
Greensberg, Pennsylvania
Study site
Hollywood, Florida
Study site
Houston, Texas
Study site
Irvine, California
Study site
Jacksonville, Florida
Study site
Kalamazoo, Michigan
Study site
Kenilworth, New Jersey
Study site
Las Vegas, Nevada
Study site
Lexington, New York
Study site
Long Branch, New Jersey
Study site
Madison, Tennessee
Study site
Medford, Oregon
Study site
Melbourne, Florida
Study site
Mesa, Arizona
Study site
New Haven, Connecticut
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
No. Charleston, North Carolina
Study site
North Miami, Florida
Study site
Ocala, Florida
Study site
Peoria, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
Providence, Rhode Island
Study site
Rochester, New York
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Francisco, California
Study site
Sarasota, Florida
Study site
Seattle, Washington
Study site
Snellville, Georgia
Study site
St. Petersburg, Florida
Study site
Staten Island, New York
Study site
Sun City, Arizona
Study site
Tampa, Florida
Study site
Toledo, Ohio
Study site
Tucson, Arizona
Study site
Venice, Florida
Study site
West Palm Beach, Florida
Study site
Wichita Falls, Texas
About this study
Official title: A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.
- Conditions
- Memory Loss
- Being tested
- Donepezil Hydrochloride, Placebo
- Keywords
- Cognitive impairment, Memory Loss
- Medical subject headings
- Memory Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil HydrochlorideDrug
Subects will receive a starting dose of 5 mg orally. Dose-escalation from 5 mg to 10 mg will occur at the Week 9 Visit.
PlaceboDrug
Subjects will receive matching placebo tablets.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Donepezil Hydrochloride |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of cognitive and global function in subjects with MCI.
Secondary outcomes (1)
Behavioral, global and cognitive outcomes; Neuroimaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startDec 2003
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory LossStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 821 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Investigators
- Anita Murthy, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293176
- Sponsor's protocol ID
- E2020-A001-412
- Status last verified
- Mar 2011
- First submitted
- 16 Feb 2006
- 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 One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
- ClinicalTrials.gov ID
- NCT00293176
- Acronym / sponsor ID
- E2020-A001-412
- Conditions
- Memory Loss
- Keywords
- Cognitive impairment, Memory Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 821 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Dec 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 17 Feb 2006 (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 efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Donepezil Hydrochloride |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Memory complaint
- Mini Mental Status Exam (MMSE) score 24-28 inclusive
- General cognition and function performance sufficiently preserved such that a diagnosis of Alzheimer's disease (AD) cannot be made
- Generally healthy and ambulatory
- Sufficiently fluent in English
Key exclusion criteria (4 listed)
- Diagnosis of probable or possible AD
- Neurological disorders
- History of malignant cancers
- Previously have taken donepezil or other acetylcholinesterase (ChE) inhibitors for more than 1 month or in the past 3 months prior to study entry
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 HydrochlorideSubects will receive a starting dose of 5 mg orally. Dose-escalation from 5 mg to 10 mg will occur at the Week 9 Visit. | Drug | 1 |
| PlaceboSubjects will receive matching placebo tablets. | Drug | 2 |
Primary outcome
Assessment of cognitive and global function in subjects with MCI.
1 secondary outcome
Behavioral, global and cognitive outcomes; Neuroimaging
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.
Anita Murthy study director
Eisai Inc.
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil Hydrochloride in people with Memory Loss, run by Eisai Inc. at 54 sites in United States.
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 4 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 54 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Assessment of cognitive and global function in subjects with MCI.. 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.