Dementia patients who are indicated for Acetylcholinesterase Inhibitors
Conditions
Interventions
Single arm:Exelon Patch (rivastigmine transdermal system)
Sponsors
None listed
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Dementia patients who are indicated for AChIs are potentially eligible for this study, i.e. AD, are of mild to moderate severity (i.e. MMSE between 10-26); 2. Patients who are currently on a sub-maximal dose of oral AChIs (e.g. 5mg daily donepezil, 6mg daily rivastigmine, 16 mg daily galantamine) due to intolerability to a higher dose; 3. Patients who are intolerable to even low dose of oral AChIs and are thus not on any oral AChIs.
Exclusion criteria
Exclusion criteria: 1. Dementia patients who are already on and are tolerating well the maximal dose of oral AChIs; 2. Dementing illnesses (e.g. frontotemporal dementia, Huntington’s chorea, head trauma) other than AD and DLB; 3. Subjects with the following co-existing medical conditions: a. Uncontrolled epilepsy, convulsions, asthmatic; b. Current clinically significant psychiatric disease, as judged by DSM-IV criteria, in particular current major depression or schizophrenia. Subjects with moderate to severe or uncontrolled behavioral disturbances are excluded. Subjects with mild disturbances who are well controlled with stable use of medication may be included; c. Peptic ulcer: if the ulcer is considered to be still ‘active’, i.e., if treatment for this condition started <3 months ago or if treatment is not successful (symptoms still present), the subject is not eligible. d. Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances. e. Clinically significant urinary outflow obstruction. Those with prostatomegaly who is on long term foley catheterization can be included. 4. Current, clinically significant cardiovascular disease that would be expected to limit the subject’s ability to complete a 26-week trial. The following would usually be considered clinically significant cardiovascular disease: a. Cardiac surgery or myocardial infarction within the past 6 months; b. Unstable cardiac disease that required a change in medication within the last 3 months; c. Decompensated congestive heart failure, i.e., when symptoms occur in a subject on stable medication during rest or light exercise (NYHA III and IV); d. Cardiac disease potentially resulting in syncope, near syncope or other alternations of mental status. In addition, the following conditions should lead to exclusion: uncontrolled atrial fibrillation, bradycardia<50 beats/min., atrioventricular block great than first degree. e. Severe mitral, aortic valvular disease, or sick sinus syndrome; f. Uncontrolled high blood pressure (systolic blood pressure greater than 170 mmHg or diastolic blood pressure greater than 110 mmHg) or sustained hypertension. 5. Female subject childbearing potential without adequate contraception. Barrier, spermicidal and hormonal methods are considered adequate contraception. Females of childbearing potential must not be pregnant at screening and must agree not to become pregnant during the trial. Females who are breast feeding are also excluded; 6. History of severe drug allergy or hypersensitivity; including recorded hypersensitivity to cholinesterase inhibitors, choline agonists or similar agents or bromide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Global Impression of Change (CGIC) at 12 weeks and 26 weeks.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The Chinese version of mini-mental state examination (MMSE) and Lawton Instrumental Activities of Daily Living (IADL at 12 weeks, and 26 weeks.; | — |
Countries
China
Contacts
Public ContactProf. Vincent CT Mok
Outcome results
None listed