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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
  Purpose

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 Intervention Phase
Progressive Supranuclear Palsy Dementia Drug: rivastigmine Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

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

Estimated Enrollment: 20
Study Start Date: February 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00522015


Contacts
Contact: Daniela Berg, Doctor +49 7071 29 80438 daniela.berg@uni-tuebingen.de
Contact: Inga Liepelt, Doctor + 49 7071 29 80424 inga.liepelt@uni-tuebingen.de

Locations
Germany
University of Tuebingen Recruiting
Tuebingen, Baden Wuerttemberg, Germany, 72076
Contact: Daniela Berg, Doctor    +49 7071 29 80438    daniela.berg@uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Daniela Berg, Doctor University Hospital Tuebingen
  More Information

Responsible Party: Professor Dr. Berg, University hospital of Tuebingen
ClinicalTrials.gov Identifier: NCT00522015     History of Changes
Other Study ID Numbers: RIVA
eudraCT no: 2006-006166-42
First Submitted: August 27, 2007
First Posted: August 29, 2007
Last Update Posted: February 18, 2008
Last Verified: August 2007

Keywords provided by University Hospital Tuebingen:
PSP
dementia
neuropsychology
treatment

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