Alzheimer's disease MedDRA version: 7 Level: VTc Classification code 10012271
Conditions
Interventions
Trade Name: Aricept
Product Name: Aricept (donepezil hydrochloride)
Product Code: E2020
Pharmaceutical Form: Tablet
INN or Proposed INN: donepezil
Current Sponsor code: E2020
Other descriptive name: 2
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 50 years or over, both men and women. Women of childbearing potential or =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients used in the formulation of donepezil Patients with active or clinically significant conditions affecting absorption, distribution or metabolism of the study medication. Patients who have been treated with a cholinesterase inhibitor in the 3 months prior to screening visit. Patients treated with any investigational drug within 30 days of screening visit. Patients without a reliable caregiver, or patients or caregivers who are unwilling or unable to complete any of the outcome measures and fulfill the requirements of this study. Nursing home patients will be excluded from entering the study. Likewise, patients for whom institutionalization is being considered within the next 3 months should also be excluded. Patients with clinically significant obstructive pulmonary disease or asthma. Patients with a recent (< 2 years) haematologic/oncologic disorders. Evidence of active clinically significant and unstable gastrointestinal, endocrine or cardiovascular system disease. Evidence of severe hepatic or renal impairment. Patients with a current DSM-lV diagnosis of Major Depressive Disorder (MDD), or any current primary psychiatric diagnosis other than Alzheimer’s disease (as per DSM-lV). Patients who, in the judgment of the investigator, represent a suicide risk. Patients with dementia complicated by other organic disease or Alzheimer’s disease with delirium (DSM 290.30 or 290.11) are excluded. Depression or delusions are common in Alzheimer’s disease, but patients with pronounced severe symptoms such that they warrant an alternative concurrent diagnosis, should be excluded. Patients with a known or suspected history of alcoholism or drug abuse (within the past 10 years). Any condition which would make the patient or the caregiver, in the opinion of the investigator or sponsor, unsuitable for the study. Patients who have taken or are taking any unapproved prior or concomitant medication as defined in the protocol. Patients with a history of seizures or seizure disorders. Patients must be able to swallow tablet medication. No crushing of tablets is allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of donepezil on cognition (MMSE) in patients who are currently being treated with memantine, and are switched to donepezil because treatment with memantine is lacking efficacy or is not well tolerated ;Secondary Objective: To evaluate the effects of donepezil on other clinically relevant measures including behaviour (NPI), physician and caregiver satisfaction/ease of use, global function (CGI-I), social behaviour (Caregiver Diary), safety and tolerability in this patient group.;Primary end point(s): Mini Mental State Examination (MMSE): The MMSE is a brief test to assess the cognitive status of the patient. The 30-point test includes items that evaluate orientation to time and place, immediate and delayed recall, attention and language. The MMSE will be administered by the same trained rater at each visit. | — |
Countries
Czech Republic, Finland, Germany, Spain
Outcome results
None listed