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Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy (psp)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00522015
First Posted: August 29, 2007
Last Update Posted: February 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Tuebingen
August 27, 2007
August 29, 2007
February 18, 2008
February 2008
December 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00522015 on ClinicalTrials.gov Archive Site
changes in speech function and improvement of quality of life [ Time Frame: 6 Month ]
Same as current
Not Provided
Not Provided
 
Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy
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
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Progressive Supranuclear Palsy
  • Dementia
Drug: rivastigmine
rivastigmine 6 mg up to 12 mg daily; Taken in two doses from 3 mg to 6 mg Rivastigmine twice a day
Other Name: Exelon
Active Comparator: 1
patients take 6 mg rivastigmine daily, if well tolerable increase to 12 mg rivastigmine maximum daily
Intervention: Drug: rivastigmine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
February 2010
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00522015
RIVA
eudraCT no: 2006-006166-42
Yes
Not Provided
Not Provided
Professor Dr. Berg, University hospital of Tuebingen
University Hospital Tuebingen
Not Provided
Principal Investigator: Daniela Berg, Doctor University Hospital Tuebingen
University Hospital Tuebingen
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP