Alzheimer's disease MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease
Conditions
Interventions
Trade Name: ARICEPT
Pharmaceutical Form: Capsule*
CAS Number: 120011703
Other descriptive name: DONEPEZIL HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is an ambulatory male or female and =55 years of age on the day of signing the consent form. 2. If female, patient is not of reproductive potential. 3. Patient has a diagnosis of probable AD according to Criteria for Clinical Diagnosis of Alzheimer’s Disease (NINCDS-ADRDA) criteria (Appendix 6.1). 4. Patient has a Mini-Mental State Examination (MMSE) score between 18 and 26, inclusive. 5. Patient has a Modified Hachinski Ischemic Scale (MHIS) score of =4. 6. Patient has a reliable informant/caregiver. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has used any of the following medications within 6 months prior to Screening Visit OR patient has ever continuously used for greater than 6 weeks OR patient has ever discontinued use due to an adverse experience: a. Tacrine (COGNEX®, Parke-Davis); b. Donepezil (Aricept®, Eisai-Pfizer); c. Rivastigmine (Exelon®, Novartis); d. Galantamine (Razadyne®, Takeda-Ortho Mcneil); e. Memantine HCL (Namenda®, Forest). 2. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent or has participated in a vaccine trial for Alzheimer's disease within the last 18 months. 3. Patient has a history or current evidence of any clinically significant condition (e.g. recent infection), therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient to participate. 4. Patient has a history or current evidence of a neurological disorder, other than AD, that in the opinion of the primary investigator may be a contributing cause of patient's cognitive impairment, including, but not limited to: a. Vascular disorder (e.g. ischemic or hemorrhagic stroke resulting in persistent neurological or cognitive deficits), b. Neurodegenerative disorder (e.g., Parkinson’s disease, progressive supranuclear palsy, Huntington’s disease, amyotrophic lateral sclerosis, Frontotemporal dementia; dementia with Lewy Bodies; amyotrophic lateral sclerosis), c. Normal Pressure Hydrocephalus (NPH) d. Epilepsy (two or more unprovoked seizures), e. Tumor (NOTE: stable, asymptomatic tumors are not exclusionary) f. Auto-immune disorder (e.g., multiple sclerosis), g. CNS infection (e.g. encephalitis, syphilis), h. Alcohol or other drug-induced dementia i. Significant head trauma with loss of consciousness that led to marked, persistent, cognitive impairment. 5. Patient currently has in the opinion of the investigator a clinically significant or unstable metabolic, immune, endocrinologic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder, including, but not limited to a. angina, b. congestive heart failure, c. cardiogenic syncope, d. any symptomatic arrhythmia requiring medical intervention e. insulin dependent diabetes, f. history of HIV seropositivity, or g. any condition that would pose a risk to the patient if they were to participate in the study or that might confound the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of donepezil over a 4-week treatment period in improving cognitive function in patients with mild-to-moderate AD as assessed by the composite score on the CogState computerized neuropsychological battery. ;Secondary Objective: 1. To evaluate the efficacy of donepezil over a 2-week, 8-week, and 12-week treatment period in improving cognitive function in patients with mild-to-moderate AD as assessed by the composite score on the CogState computerized neuropsychological battery. 2. To evaluate the efficacy of donepezil over a 4-week, 8-week, and 12-week treatment period in improving cognitive function in patients with mild-to-moderate AD as measured by the total score from the 11 tasks of the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog). ;Primary end point(s): CogState and ADAS-Cog | — |
Countries
Hungary, Lithuania
Outcome results
None listed