Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy

NCT00522015 | Unknown Phase 2 DMC

• 2 other identifiers: RIVAeudraCT no: 2006-006166-42
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

to show that

1. 1.patients improve and stabilize after 12 -24 week treatment with rivastigmine in memory function
2. 2.use of rivastigmine has a positive effect on apathy in PSP patients
3. 3.therapy with rivastigmine has a no positive benefit on speech and overall results of the MMST
4. 4.changes in motor activity are associated with changes in language and overall results of the in MMST

Conditions

Progressive Supranuclear Palsy; Dementia

Keywords

PSP; dementia; neuropsychology; treatment

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• changes in speech function and improvement of quality of life

  6 Month

Study Arms (1)

1

ACTIVE COMPARATOR

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

Drug: rivastigmine

Interventions

rivastigmine DRUG

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

Also known as: Exelon

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University of Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Dementia

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Daniela Berg, Doctor

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 29, 2007
• Study Start: February 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: February 18, 2008

Record last verified: 2007-08

Locations

DE (1)