Alzheimer'
Conditions
Interventions
Intervention of medicine, 1. Patients will be started using 4.5mg rivastigmine, and will be increased 4.5mg additionally every four weeks until a maintenance dose is reached. Maintenance dose is 18
Sponsors
Ichihino Memorial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Those who fall into the following criteria will be included in this study: 1) Patients themselves or their proxies can voluntarily provide informed consent to participate in this study 2) At age of 50 or older 3) Patients meet the probable AD criteria (using NIA-AA, 2011), and are diagnosed as having mild or moderate Alzheimer's disease 4) Either untreated or treated with medication for AD (using donepezil, galanthamine, or memantine) and willing to use rivastigmine instead, and meet one of the following conditions: a) using the medicine over a half year, but shows no improvement in symptoms b) experiencing side effects such as nausea, vomiting, or diarrhea for a long period of time and hard to continue with the medication, or c) experiencing a decrease in medication compliance.
Exclusion criteria
Exclusion criteria: Patients who fall into one of the following criteria will be excluded from this study: 1) Patients with neurodegenerative disease, schizophrenia, bipolar disorder, or other disease classified in DSM-IV Axis I 2) Patients with DLB, or other systemic disease or neurological disorder (dysthyroidism, vitamin B12 or folic acid deficiency, after head injury, Huntington disease, Parkinson's disease, intradural hematoma, normal pressure hydrocephalus, brain tumor, syphilis, etc.) 3) Patients diagnosed as having VD, or possible VD based on NINDS-AIREN diagnostic criteria 4) Patients with severe cardiovascular disorder 5) Patients with bradycardia (< 50bpm), sick sinus syndrome, or conduction disturbance 6) Patients with acute, severe, or unstable symptoms of asthma 7) Patients showing hypersensitiveness to components of rivastigmine or to carbamate derivative 8) Patients after operation of gastrectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Amount of change of blood active and inactive ghrelin * Change of BuChE activity | — |
Secondary
| Measure | Time frame |
|---|---|
| * Mean amount of weekly food intake * Amount of change of body weight * Psychological attitude including appetite * Cognitive ability assessed by HDS-R * Adverse event | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Support Business for Clinical Research on Medicines
Outcome results
None listed