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

February 14, 2008 updated by: University Hospital Tuebingen

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Baden Wuerttemberg
      • Tuebingen, Baden Wuerttemberg, Germany, 72076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Exelon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in speech function and improvement of quality of life
Time Frame: 6 Month
6 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Daniela Berg, Doctor, University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 27, 2007

First Posted (Estimate)

August 29, 2007

Study Record Updates

Last Update Posted (Estimate)

February 18, 2008

Last Update Submitted That Met QC Criteria

February 14, 2008

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIVA
  • eudraCT no: 2006-006166-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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