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: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

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
    

Secondary Measures

• changes in speech function and improvement of quality of life
  • Time Frame: 6 Month
    

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

Lead Sponsor: University Hospital Tuebingen

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

Information obtained from ClinicalTrials.gov on January 08, 2009

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