Efficacy Study for Treatment of Dementia in Progressive S... | NCT00522015

Studies
Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy

NCT00522015

Sponsor

University Hospital Tuebingen

Status

Unknown status

Last Update Posted

Feb 18, 2008Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Progressive Supranuclear Palsy
Dementia

Interventions

rivastigmine

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
eudraCT no: 2006-006166-42

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Dec 2009

Completion Date

Feb 2010

First Submitted Date

Aug 27, 2007

First Submission Date that Met QC Criteria

Aug 27, 2007

First Posted Date

Aug 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2008

Last Update Posted Date

Feb 18, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	patients take 6 mg rivastigmine daily, if well tolerable increase to 12 mg rivastigmine maximum daily	Drug: rivastigmine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rivastigmine	Drug	rivastigmine 6 mg up to 12 mg daily; Taken in two doses from 3 mg to 6 mg Rivastigmine twice a day	1

Outcomes Module

Primary Outcomes

Measure	Description	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)"		6 month

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniela Berg, Doctor	Contact	+49 7071 29 80438		daniela.berg@uni-tuebingen.de
Inga Liepelt, Doctor	Contact	+ 49 7071 29 80424		inga.liepelt@uni-tuebingen.de

Overall Officials

Name	Affiliation	Role
Daniela Berg, Doctor	University Hospital Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Tuebingen	Recruiting	Tübingen	Baden-Wurttemberg	72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
D013494	Supranuclear Palsy, Progressive
D003704	Dementia

Ancestor Terms

ID	Term
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068836	Rivastigmine

Ancestor Terms

ID	Term
D048448	Phenylcarbamates
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided