Patients with possible or probable Alzheimer disease (AD)
Conditions
Interventions
Trade Name: Exelon
Product Name: Exelon
Pharmaceutical Form: Capsule*
INN or Proposed INN: rivastigmine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5, 3.0,-4
Sponsors
Karolinska University Hospital, Huddinge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with possible or probable AD, age 55-95 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Other types of dementia (i.e. Frontotemporal dementia, Pick´s disease, vascular dementia and others) Medical or neurological disease, current diagnosis of active uncontrolled peptic ulceratio within the last 3 months, significant hepatic or renal impairment, anemia, hypothyroidism, untrated vitamine B12 or folic acid deficiency, current maligniant disease or uncontrolled diabetes or othe diseases which will make the patients unsuitable for the trials according to the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): To evaluate the which doseescalating interval that will give the optimal treatment dose with a minimum of gastrointestinal side-effects. To evaluate the frequency and intesity of gastrointestina side-effects in patients with current or past infection with Helicobacter Pylori.;Main Objective: To investigate the optamal doseescaling regieme with the lowest possible gastrointestinal side-effects;Secondary Objective: To investigate if current or past infection with Helicobacter pylori will increase the risk of gastrointestinal side-effects of patients treated with rivastigmine. | — |
Countries
Sweden
Outcome results
None listed