Exelon bei dementiellem Syndrom bei Patienten mit Progressiver Supranukleärer Parese -offene, prospektive Phase II-Studie

Conditions: Progressive supranuclear palsy (PSP) is a neurodegenerative disorder with hardly any therapeutical option to ameliorate the course of the disease. Results of first trials with physostigmine and donepezil did not point out a definite benefit. In contrast, first clinical observations concerning an effect with rivastigmine in PSP with dementia were promising. This may be due to the fact, that rivastigmine excerts a double action inhibiting both the acetylcholin- and the buturylcholinesterase.

Registration Number: EUCTR2006-006166-42-DE

Lead Sponsor: niversity of Tuebingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria for study participation are:
1) definite diagnosis of PSP and dementia
2) informed consent to study participation
3) MMST > 18, therefore ability to give informed consent
4) age over 50 years
5) existence of a caregiver who can be suppervise the process of study medication
6) ability to communicate verbally
7) no other diseases affecting the central nervous system
8) adequate capacity for study participation and steady state of health
9) ability for consent is controlled by an independent physician
10) written consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. history of addiction to alcohol or drugs
2. signs of psychosis
3. former history of ChEI medication
4. pregnancy and breast feeding
5. history of hypersensitivity aganst rivastigmine
6. severe liver insufficiency
7. history of sick-sinus-syndrom
8. bronchial asthma or obstructiv lung desease
9. activ gastric ulcer or duodenal ulcer
10. history of retention of urine
11. history of convulsion

anamnestisch erhobener Alkoholabusus
2.akute Psychose
3.Einnahme von Cholinesterasehemmern
4.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objective of the trial is to improve memory disturbances and to reduce the dysexecutive syndrom in patients with PSP and dementia in the course of a 24 weeks treatment phase with the ChEI rivastigmine. Also side effects should be dixcovered;Secondary Objective: We hypothesize that treatment with rivastigmine in patients with PSP and dementia will also<br>1) improve other cognitive functions, e.g. speech<br>2) reduce behavioural disturbances<br>3) increase quality of patient’s life<br>4) has an impact on the medication of motor symptoms. ;Primary end point(s): <br>1. verbal memory (see WMSR-test = Wechsler Gedächtnistest revidierte Fassung)<br>2. „logical memory II (see WMSR-test)<br>3. Tower of London -Test<br>4. CERAD: subtest„Verbale Flüssigkeit

Secondary Outcome Measures