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

University Hospital Tuebingen

Status and phase: Unknown; Phase 2

Conditions: Progressive Supranuclear Palsy; Dementia

Treatments: Drug: rivastigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT00522015

RIVA

eudraCT no: 2006-006166-42

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Active Comparator group

Description:

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

Treatment:

Drug: rivastigmine