Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aricept (donepezil hydrochloride) | Drug | 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs) | Baseline, Week 6, Week 12 and Week 28. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anita Murthy | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Neurodiagnostic Lab, LLC | Alabaster | Alabama | 35007 | United States | ||
| Pivotal Research Centers |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Donepezil | 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug |
|
| Peoria |
| Arizona |
| 85381 |
| United States |
| Sun Health Research Institute | Sun City | Arizona | 85351 | United States |
| Northwest Neurospecialists, PLLC | Tucson | Arizona | 85741-3537 | United States |
| The Neurology Center | Encinitas | California | 92024 | United States |
| Margolin Brain Institute | Fresno | California | 93720 | United States |
| Colaborative Neuroscience Network (CNS Network) | Garden Grove | California | 92845 | United States |
| Nerve Pro Research | Irvine | California | 92618 | United States |
| Optimum Health Services | La Mesa | California | 91942 | United States |
| Pacific Research Network | San Diego | California | 92103 | United States |
| Neurological Research Institute | Santa Monica | California | 90404 | United States |
| CA Neuroscience Research | Sherman Oaks | California | 91403 | United States |
| Pacific Research Network | Vista | California | 92081 | United States |
| Yale University Alzheimers Disease Research Unit School of Medicine Department of Psychiatry | New Haven | Connecticut | 06510 | United States |
| North Broward Medical Center Memory Disorder Center | Deerfield Beach | Florida | 33064 | United States |
| Neurologic Consultants | Fort Lauderdale | Florida | 33308 | United States |
| Berma Research Group | Hialeah | Florida | 33016 | United States |
| Sunrise Clinical Research | Hollywood | Florida | 33021 | United States |
| Wien Center for Memory Disorders, Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Berma Research Group | Plantation | Florida | 33317 | United States |
| The Roskamp Institute | Sarasota | Florida | 34243 | United States |
| Comprehensive Neuroscience, Inc. | St. Petersburg | Florida | 33702 | United States |
| Stedman Clinical Trials, LLC | Tampa | Florida | 33613 | United States |
| USF Memory Disorder's Clinic | Tampa | Florida | 33613 | United States |
| USF Suncoast Gerontalogy Center | Tampa | Florida | 33617 | United States |
| Center for Clinical Trials. L.C. | Venice | Florida | 34285 | United States |
| Palm Beach Neurology | West Palm Beach | Florida | 33407 | United States |
| Lexington Clinic | Lexington | Kentucky | 40504 | United States |
| Borgess Research Institute | Kalamazoo | Michigan | 49048 | United States |
| St. Louis University - Clinical Trials Unit | St Louis | Missouri | 63104 | United States |
| Comprehensive Neuroscience, Inc | Kenilworth | New Jersey | 07033 | United States |
| Neurological Associates of Albany, PC Neurology | Albany | New York | 12208 | United States |
| Neurobehavioral Research Inc. | Lawrence | New York | 11559 | United States |
| New York University School of Medicine Aging and Dementia Research Center | New York | New York | 10016 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Monroe Community Hospital Program in Neurobehavioral Therapeutics | Rochester | New York | 14620 | United States |
| Behavioral Medical Research of Staten Island | Staten Island | New York | 10305 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Neurology Center of Ohio | Toledo | Ohio | 43623 | United States |
| Pahl Pharmaceutical Research, LLC | Oklahoma City | Oklahoma | 73118 | United States |
| Summit Research Network(Oregon) Inc. | Portland | Oregon | 97210 | United States |
| Clinical Trial Specialists | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Westmoreland Neurology Associates | Greensburg | Pennsylvania | 15601 | United States |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | United States |
| Medical University of South Carolina-Alzheimer's Research | Charleston | South Carolina | 29406 | United States |
| The University of Texas Mental Sciences Instittute | Houston | Texas | 77030 | United States |
| START Center | San Antonio | Texas | 78229-3900 | United States |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | United States |
| Southwestern Vermont Medical Center - The Memory Clinc | Bennington | Vermont | 05201 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Donepezil | 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day. |
| BG001 | Placebo | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events | Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs) | Posted | Number | Participants | Baseline, Week 6, Week 12 and Week 28. |
|
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donepezil | 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day. | 3 | 68 | 11 | 68 | ||
| EG001 | Placebo | 2 | 77 | 20 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Pelvic Fracture | Injury, poisoning and procedural complications |
| |||
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Abnormal dreams | Psychiatric disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Muscle Spasms | Musculoskeletal and connective tissue disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anita Murthy, Study Director | Eisai Inc. | 201-692-1100 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Any possibly/probably drug-related TEAE |
|
| Any TEAE causing discontinuation of study drug. |
|