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

Primary Purpose

Progressive Supranuclear Palsy, Dementia

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
rivastigmine
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Supranuclear Palsy focused on measuring PSP, dementia, neuropsychology, treatment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of TuebingenRecruiting

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

patients take 6 mg rivastigmine daily, if well tolerable increase to 12 mg rivastigmine maximum daily

Outcomes

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)"

Secondary Outcome Measures

changes in speech function and improvement of quality of life

Full Information

First Posted
August 27, 2007
Last Updated
February 14, 2008
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT00522015
Brief Title
Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy
Acronym
psp
Official Title
Rivastigmine (Exelon®) for Treatment of Dementia in Patient With Progressive Supranuclear Paresis Open Label Phase 2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2009 (undefined)
Study Completion Date
February 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
to show that patients improve and stabilize after 12 -24 week treatment with rivastigmine in memory function use of rivastigmine has a positive effect on apathy in PSP patients therapy with rivastigmine has a no positive benefit on speech and overall results of the MMST changes in motor activity are associated with changes in language and overall results of the in MMST

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Supranuclear Palsy, Dementia
Keywords
PSP, dementia, neuropsychology, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
patients take 6 mg rivastigmine daily, if well tolerable increase to 12 mg rivastigmine maximum daily
Intervention Type
Drug
Intervention Name(s)
rivastigmine
Other Intervention Name(s)
Exelon
Intervention Description
rivastigmine 6 mg up to 12 mg daily; Taken in two doses from 3 mg to 6 mg Rivastigmine twice a day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
changes in speech function and improvement of quality of life
Time Frame
6 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Berg, Doctor
Phone
+49 7071 29 80438
Email
daniela.berg@uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Inga Liepelt, Doctor
Phone
+ 49 7071 29 80424
Email
inga.liepelt@uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Berg, Doctor
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tuebingen
City
Tuebingen
State/Province
Baden Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Berg, Doctor
Phone
+49 7071 29 80438
Email
daniela.berg@uni-tuebingen.de

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy

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