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

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. Identifier: NCT00522015
Recruitment Status : Unknown
Verified August 2007 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : August 29, 2007
Last Update Posted : February 18, 2008
Information provided by:
University Hospital Tuebingen

Brief 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

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Dementia Drug: rivastigmine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rivastigmine (Exelon®) for Treatment of Dementia in Patient With Progressive Supranuclear Paresis Open Label Phase 2 Study
Study Start Date : February 2008
Primary Completion Date : December 2009
Study Completion Date : February 2010

Arm Intervention/treatment
Active Comparator: 1
patients take 6 mg rivastigmine daily, if well tolerable increase to 12 mg rivastigmine maximum daily
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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. changes in speech function and improvement of quality of life [ Time Frame: 6 Month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00522015

Contact: Daniela Berg, Doctor +49 7071 29 80438
Contact: Inga Liepelt, Doctor + 49 7071 29 80424

University of Tuebingen Recruiting
Tuebingen, Baden Wuerttemberg, Germany, 72076
Contact: Daniela Berg, Doctor    +49 7071 29 80438   
Sponsors and Collaborators
University Hospital Tuebingen
Principal Investigator: Daniela Berg, Doctor University Hospital Tuebingen

Responsible Party: Professor Dr. Berg, University hospital of Tuebingen Identifier: NCT00522015     History of Changes
Other Study ID Numbers: RIVA
eudraCT no: 2006-006166-42
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: February 18, 2008
Last Verified: August 2007

Keywords provided by University Hospital Tuebingen:

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Basal Ganglia Diseases
Movement Disorders
Ocular Motility Disorders
Cranial Nerve Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents