Mild Cognitive ImpairmentPhase 4NCT00934375
A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment
A Phase 4 study testing Aricept (donepezil hydrochloride) in people with Mild Cognitive Impairment, run by Eisai Inc. at 49 sites in United States.
Trial summary
This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412). Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Aricept (donepezil hydrochloride)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 49 sitesUnited States
- Study dates
- Feb 2006to Sep 2007
- Phase
- Phase 4
- 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 45 to 90 years
- All sexes
- Adult, Older adult
Who may be able to join
- Age Range: Adult subjects (45 to 90 years of age inclusive)
- Sex distribution: Men and women. Women of child-bearing potential (<1 year post menopausal) must be practicing effective contraception and have negative serum B-HCG at Screening. [Women who are breast-feeding are excluded.]
- Subjects must have completed the one year, double-blind core trial (E2020-A001-412).
- A completed Diagnostic Worksheet at the end of the double-blind core trial (E2020-A001-412) indicating no conversion to Alzheimer's Disease or dementia.
- Health: Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
- The subject must be expected to complete the entire study.
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- Subjects must be sufficiently fluent in English.
- Subjects must have an informant who has daily contact with the subject (e.g., an average of 10 or more hours per week), can observe for possible adverse events and will accompany the subject to all visits.
- Clinical laboratory values must be within normal limits, or if abnormal, judged clinically insignificant by the investigator (not likely to cause cognitive impairment or medical instability).
Who cannot join
- Subjects who have not completed or have terminated early from the one year, double-blind core trial (E2020-A001-412).
- Any subject without a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412).
- Any subject with a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412) indicating conversion to Alzheimer's or other dementia.
- Subjects with uncontrolled hypertension (sitting systolic >= 160mmHg and/or diastolic >=95mmHg) as assessed by the investigator, regardless of whether or not the subject is taking anti-hypertensive medications.
- Subjects with a history of malignant neoplasms treated within five years prior to study entry (other than basal or squamous cell carcinoma of the skin); current evidence of malignant neoplasm; or recurrent or matastatic disease.
- Subjects who have suffered a severe infection or a major surgical procedure within three months prior to baseline.
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- Subjects who may not be able to comply with the protocol.
- Subjects with known hypersensitivity to piperidine derivatives or acetylcholinesterase(AChE)inhibitors.
- Subjects with diabetes mellitis not controlled by diet and/or medication with a random serum glucose value of >170mg/dl.
- Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
- Subjects who do not have a reliable informant (e.g., the informant has contact with the subject less than 10 hours per week).
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
United States49 sites
Neurology Neurodiagnostic Lab, LLC
Alabaster, Alabama, 35007
Neurological Associates of Albany, PC Neurology
Albany, New York, 12208
Clinical Trial Specialists
Bala-Cynwyd, Pennsylvania, 19004
Southwestern Vermont Medical Center - The Memory Clinc
Bennington, Vermont, 05201
Medical University of South Carolina-Alzheimer's Research
Charleston, South Carolina, 29406
The Ohio State University
Columbus, Ohio, 43210
North Broward Medical Center Memory Disorder Center
Deerfield Beach, Florida, 33064
The Neurology Center
Encinitas, California, 92024
Neurologic Consultants
Fort Lauderdale, Florida, 33308
Margolin Brain Institute
Fresno, California, 93720
Colaborative Neuroscience Network (CNS Network)
Garden Grove, California, 92845
Westmoreland Neurology Associates
Greensburg, Pennsylvania, 15601
Berma Research Group
Hialeah, Florida, 33016
Sunrise Clinical Research
Hollywood, Florida, 33021
The University of Texas Mental Sciences Instittute
Houston, Texas, 77030
Nerve Pro Research
Irvine, California, 92618
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046
Borgess Research Institute
Kalamazoo, Michigan, 49048
Comprehensive Neuroscience, Inc
Kenilworth, New Jersey, 07033
Optimum Health Services
La Mesa, California, 91942
Neurobehavioral Research Inc.
Lawrence, New York, 11559
Lexington Clinic
Lexington, Kentucky, 40504
Wien Center for Memory Disorders, Mount Sinai Medical Center
Miami Beach, Florida, 33140
Yale University Alzheimers Disease Research Unit School of Medicine Department of Psychiatry
New Haven, Connecticut, 06510
New York University School of Medicine Aging and Dementia Research Center
New York, New York, 10016
Columbia University
New York, New York, 10032
Pahl Pharmaceutical Research, LLC
Oklahoma City, Oklahoma, 73118
Pivotal Research Centers
Peoria, Arizona, 85381
Berma Research Group
Plantation, Florida, 33317
Summit Research Network(Oregon) Inc.
Portland, Oregon, 97210
Monroe Community Hospital Program in Neurobehavioral Therapeutics
Rochester, New York, 14620
START Center
San Antonio, Texas, 78229-3900
Pacific Research Network
San Diego, California, 92103
Neurological Research Institute
Santa Monica, California, 90404
The Roskamp Institute
Sarasota, Florida, 34243
CA Neuroscience Research
Sherman Oaks, California, 91403
St. Louis University - Clinical Trials Unit
St Louis, Missouri, 63104
Comprehensive Neuroscience, Inc.
St. Petersburg, Florida, 33702
Behavioral Medical Research of Staten Island
Staten Island, New York, 10305
Sun Health Research Institute
Sun City, Arizona, 85351
Stedman Clinical Trials, LLC
Tampa, Florida, 33613
USF Memory Disorder's Clinic
Tampa, Florida, 33613
USF Suncoast Gerontalogy Center
Tampa, Florida, 33617
Neurology Center of Ohio
Toledo, Ohio, 43623
Northwest Neurospecialists, PLLC
Tucson, Arizona, 85741-3537
Center for Clinical Trials. L.C.
Venice, Florida, 34285
Pacific Research Network
Vista, California, 92081
Palm Beach Neurology
West Palm Beach, Florida, 33407
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
About this study
This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Aricept (donepezil hydrochloride), placebo
- Keywords
- Mild Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aricept (donepezil hydrochloride)Drug
Also called donepezil hydrochloride
5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Aricept (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.
Number of Participants With Treatment-Emergent Adverse Events
Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)
Measured: Baseline, Week 6, Week 12 and Week 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startFeb 2006
- Primary completionSep 2007
- Study completionSep 2007
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 Mild Cognitive ImpairmentStudies 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
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anita Murthy, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934375
- Sponsor's protocol ID
- E2020-A001-414
- Status last verified
- Dec 2013
- First submitted
- 14 May 2009
- Last updated
- 14 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT00934375
- Acronym / sponsor ID
- E2020-A001-414
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Posted 8 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Aricept (donepezil hydrochloride) |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age Range: Adult subjects (45 to 90 years of age inclusive)
- Sex distribution: Men and women. Women of child-bearing potential (<1 year post menopausal) must be practicing effective contraception and have negative serum B-HCG at Screening. [Women who are breast-feeding are excluded.]
- Subjects must have completed the one year, double-blind core trial (E2020-A001-412).
- A completed Diagnostic Worksheet at the end of the double-blind core trial (E2020-A001-412) indicating no conversion to Alzheimer's Disease or dementia.
- Health: Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
Key exclusion criteria (11 listed)
- Subjects who have not completed or have terminated early from the one year, double-blind core trial (E2020-A001-412).
- Any subject without a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412).
- Any subject with a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412) indicating conversion to Alzheimer's or other dementia.
- Subjects with uncontrolled hypertension (sitting systolic >= 160mmHg and/or diastolic >=95mmHg) as assessed by the investigator, regardless of whether or not the subject is taking anti-hypertensive medications.
- Subjects with a history of malignant neoplasms treated within five years prior to study entry (other than basal or squamous cell carcinoma of the skin); current evidence of malignant neoplasm; or recurrent or matastatic 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 |
|---|---|---|
| Aricept (donepezil hydrochloride)Also: donepezil hydrochloride5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day. | Drug | 1 |
| placebo | Drug | 2 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Baseline, Week 6, Week 12 and Week 28.
Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- 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.
Anita Murthy study director
Eisai Inc.
49 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 Aricept (donepezil hydrochloride) in people with Mild Cognitive Impairment, run by Eisai Inc. at 49 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 9 inclusion and 11 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 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 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?
Yes. Results are posted in the registry (first posted 8 Jul 2009). 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 Treatment-Emergent Adverse Events (time frame: Baseline, Week 6, Week 12 and Week 28.). 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 14 Jan 2014.