Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy

NCT ID: NCT00522015

Last Updated: 2008-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Progressive Supranuclear Palsy Dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

rivastigmine

Intervention Type DRUG

rivastigmine 6 mg up to 12 mg daily; Taken in two doses from 3 mg to 6 mg Rivastigmine twice a day

Interventions

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rivastigmine

rivastigmine 6 mg up to 12 mg daily; Taken in two doses from 3 mg to 6 mg Rivastigmine twice a day

Intervention Type DRUG

Other Intervention Names

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Exelon

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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University hospital of Tuebingen

Principal Investigators

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Daniela Berg, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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University of Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Daniela Berg, Doctor

Role: CONTACT

+49 7071 29 80438

Inga Liepelt, Doctor

Role: CONTACT

+ 49 7071 29 80424

Facility Contacts

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Daniela Berg, Doctor

Role: primary

+49 7071 29 80438

Other Identifiers

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eudraCT no: 2006-006166-42

Identifier Type: -

Identifier Source: secondary_id

RIVA

Identifier Type: -

Identifier Source: org_study_id

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