Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy
to show that 1. patients improve and stabilize after 12 -24 week treatment with rivastigmine in memory function 2. use of rivastigmine has a positive effect on apathy in PSP patients 3. therapy with rivastigmine has a no positive benefit on speech and overall results of the MMST 4. changes in motor activity are associated with changes in language and overall results of the in...
Brief Summary
Official Title: “Rivastigmine (Exelon®) for Treatment of Dementia in Patient With Progressive Supranuclear Paresis Open Label Phase 2 Study”
to show that
1. patients improve and stabilize after 12 -24 week treatment with rivastigmine in memory function
2. use of rivastigmine has a positive effect on apathy in PSP patients
3. therapy with rivastigmine has a no positive benefit on speech and overall results of the MMST
4. changes in motor activity are associated with changes in language and overall results of the in MMST
- Study Type: Interventional
- Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: December 2009
Intervention(s) in this Clinical Trial
- Drug: rivastigmine
- rivastigmine 6 mg up to 12 mg daily; Taken in two doses from 3 mg to 6 mg Rivastigmine twice a day
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- patients take 6 mg rivastigmine daily, if well tolerable increase to 12 mg rivastigmine maximum daily
Outcome Measures for this Clinical Trial
Primary Measures
- improvement in neuropsychological assessments for memory and executive function, e.g. tested by "Tower of London Test, CERAD Battery and Logical Memory Test (WMSR)"
- Time Frame: 6 month
- Time Frame: 6 month
Secondary Measures
- changes in speech function and improvement of quality of life
- Time Frame: 6 Month
- Time Frame: 6 Month
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- diagnosis of PSP
- willingness to participate in the study
- informed consent
- ability to speak
- no further CNS diseases
- written informed consent
- stable state of health
- ability to give informed consent, will checked by an independent physician
Exclusion Criteria:
- alcohol abuses
- acute psychosis
- pregnancy or lactation
- known previous drug reaction or hypersensitivity of rivastigmine or other carbamate derivatives
- liver failure
- known sick sinus syndrome or excitation disturbance
- known ulcus ventriculi or duodenal ulcer
- known asthma or COPD
- seizures
- renal failure
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: University Hospital Tuebingen Other
Overall Clinical Trial Officials and Contacts
Daniela Berg, Doctor Principal Investigator University Hospital Tuebingen
Overall Contact: Daniela Berg, Doctor +49 7071 29 80438 daniela.berg@uni-tuebingen.de
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00522015
Study ID Number: RIVA
ClinicalTrials.gov Identifier: NCT00522015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00522015
