Dementia skin sensitization Rivastigmine transdermal patch Dementia
Conditions
Interventions
Experimental Drug
Rivastigmine Transdermal patch,
1 patch once daily,
dose 4.6 mg/24hr for 4 weeks then 9.5 mg/24hr upto 24 weeks
Sponsors
Berlin Pharmaceutical Industry Co., Ltd.
Center of Excellence in Stroke,
Thammasat University
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male and Female with Age >= 50 year old 2. Diagnosis of Dementia by DSM-V from AD with VCD or Propable PD requires treatment of Rivastigmine transdermal patch 3. Thai Mental State Examination (TMSE) score of 10 – 20 /30 or MoCA 24/30 4. Able to read and communication 5. Able to sign ICF by patients or patient representative
Exclusion criteria
Exclusion criteria: 1. Generalized Skin Diseases e.g. moderate-severe psoriasis, generalized eczema, allergy to transdermal patch, skin allergic diseases 2. Advanced, severe, or unstable diseases e.g. Uncontrolled Seizure disorders, Unstable Cardiovascular diseases, Major depressive episode etc. 3. Modified Hoehn and Yahr Staging 5 (UPDRS Part V)) and undergone stereotaxic brain surgery 4. Treatable dementia caused by hypothyroidism, syphilis, vitamin B12 or folate deficiency, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of site reaction 3 months, 6 months % of skin reaction | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of Rivastigmine transdermal patch 3 months, 6 months mean change of MOCA/TMSE scores,Drug compliance 1 month, 3 months, 6 months % compliance | — |
Contacts
Public ContactSombat Muengtaweepongsa
Faculty of Medicine, Thammasat University
Outcome results
None listed