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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by University Hospital Tuebingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00522015
First received: August 27, 2007
Last updated: February 14, 2008
Last verified: August 2007
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 27, 2007
Last Updated: February 14, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
PSP
dementia
neuropsychology
treatment

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

ClinicalTrials.gov processed this record on November 25, 2014