Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy

Dementia Clinical Trial

— psp  

Official title:

Rivastigmine (Exelon®) for Treatment of Dementia in Patient With Progressive Supranuclear Paresis Open Label Phase 2 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00522015
• Other study ID #: RIVA
• Secondary ID: eudraCT no: 2006
• Status: Recruiting
• Phase: Phase 2
• First received: August 27, 2007
• Last updated: February 14, 2008
• Start date: February 2008
• Est. completion date: February 2010

Study information

• Verified date: August 2007
• Source: University Hospital Tuebingen
• Contact: Daniela Berg, Doctor
• Phone: +49 7071 29 80438
• Email: daniela.berg[@]uni-tuebingen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Drug:
• rivastigmine
rivastigmine 6 mg up to 12 mg daily; Taken in two doses from 3 mg to 6 mg Rivastigmine twice a day

Locations

Country	Name	City	State
Germany	University of Tuebingen	Tuebingen	Baden Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in neuropsychological assessments for memory and executive function, e.g. tested by "Tower of London Test, CERAD Battery and Logical Memory Test (WMSR)"		6 month
Secondary	changes in speech function and improvement of quality of life		6 Month