Changes of cognitive function in patients with Alzheimer’s disease associated with or without white matter lesions after rivastigmine patch therapy
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0000551
- Lead Sponsor
- Dong-A University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
1. Age range : 50 - 90 years of age
2. AD in NINCDS-ADRDA criteria, mild to moderate probable AD with or without mild to moderate whiter matter lesions, excluding multiple large vessel infarcts or a single, strategically placed infarct (angular gyrus, thalamus, basal forebrain, territory of the posterior or anterior cerebral artery) on MRI scan (within 12 months)
3. MMSE score : 10 to 26 at screening
4. Hachinski scores = 4
5. Who have a reliable caregiver who met the patient at least once a week and was sufficiently familiar with the patient to provide the investigator with accurate information
6. Who are ambulatory or ambulatory-aided (i.e., walker or cane)
1.Subjects with any primary neurodegenerative disorder or psychiatric disorder other than AD (i.e., Parkinson’s disease, schizophrenia, or major depressive disorder)
2.Subjects with clinically significant laboratory abnormalities such as an abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or positive Venereal Disease Research Laboratory test
3.Subjects with any history of drug or alcohol addiction for the past 10 years
4.Subjects with any severe or unstable medical disease that may have prevented the patient from completing all study requirements (i.e., unstable or severe asthma or cardiovascular disease, active gastric ulcer, severe hepatic or renal disease)
5.Subjects with bradycardia with less than 50 beats per minute, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block
6. Subjects with any active skin lesion
7. Subjects with a history of allergy to topical products containing any of the constitution of the patches
8.Subjects who had known hypersensitivity to cholinesterase inhibitors
9. Subjects with any hearing or visual impairment that could disturb the efficient evaluation of the patient
10. Who had an involvement in other clinical trials or treated by any experimental drug within 4 weeks
11. probable AD with severe whiter matter lesion or with smultiple large vessel infarcts or a single, strategically placed infarct (angular gyrus, thalamus, basal forebrain, territory of the posterior or anterior cerebral artery) on MRI scan (within 12 months)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method he changes of cognitive function (as measured by ADAS-Cog) in the two group of patients with Alzheimer’s disease
- Secondary Outcome Measures
Name Time Method MMSE (Mini-Mental State Examination) ;Frontal Assessment Battery (FAB);Alzheimer’s Disease Cooperative Study - Activities of Daily Living (ADCS-ADL);Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI);Caregiver burden scale - Korean Version of mini-Zarit;Safeties (vital sign, weight, physcial examination, neurologic examination, adverse effects)