Progressive Supranuclear PalsyPhase 2pspNCT00522015
Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy
A Phase 2 study testing rivastigmine in people with Progressive Supranuclear Palsy and Dementia, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Progressive Supranuclear Palsy, Dementia
- What is being tested?
- rivastigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to Feb 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- known ulcus ventriculi or duodenal ulcer
- known asthma or COPD
- seizures
- renal failure
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Tuebingen
Tübingen, Baden-Wurttemberg, 72076
Daniela Berg, Doctor, +49 7071 29 80438, daniela.berg@uni-tuebingen.de
About this study
Official title: Rivastigmine (Exelon®) for Treatment of Dementia in Patient With Progressive Supranuclear Paresis Open Label Phase 2 Study
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
- Conditions
- Progressive Supranuclear Palsy, Dementia
- Being tested
- rivastigmine
- Keywords
- PSP, dementia, neuropsychology, treatment
- Medical subject headings
- Supranuclear Palsy, Progressive, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rivastigmineDrug
Also called Exelon
rivastigmine 6 mg up to 12 mg daily; Taken in two doses from 3 mg to 6 mg Rivastigmine twice a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | patients take 6 mg rivastigmine daily, if well tolerable increase to 12 mg rivastigmine maximum daily Receives: Drug: rivastigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in neuropsychological assessments for memory and executive function, e.g. tested by "Tower of London Test, CERAD Battery and Logical Memory Test (WMSR)"
Measured: 6 month
Secondary outcomes (1)
changes in speech function and improvement of quality of life
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startFeb 2008
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Supranuclear PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Daniela Berg, Doctor, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522015
- Sponsor's protocol ID
- RIVA
- Other IDs
- eudraCT no: 2006-006166-42
- Acronym
- psp
- Status last verified
- Aug 2007
- First submitted
- 27 Aug 2007
- Last updated
- 18 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rivastigmine (Exelon®) for Treatment of Dementia in Patient With Progressive Supranuclear Paresis Open Label Phase 2 Study
- ClinicalTrials.gov ID
- NCT00522015
- Acronym / sponsor ID
- psp / RIVA
- Conditions
- Progressive Supranuclear Palsy, Dementia
- Keywords
- PSP, dementia, neuropsychology, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2009
- Study completion
- Feb 2010
- First posted
- 29 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: rivastigminepatients take 6 mg rivastigmine daily, if well tolerable increase to 12 mg rivastigmine maximum daily |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- diagnosis of PSP
- willingness to participate in the study
- informed consent
- ability to speak
- no further CNS diseases
Key exclusion criteria (10 listed)
- alcohol abuses
- acute psychosis
- pregnancy or lactation
- known previous drug reaction or hypersensitivity of rivastigmine or other carbamate derivatives
- liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rivastigmineAlso: Exelonrivastigmine 6 mg up to 12 mg daily; Taken in two doses from 3 mg to 6 mg Rivastigmine twice a day | Drug | 1 |
Primary outcome
improvement in neuropsychological assessments for memory and executive function, e.g. tested by "Tower of London Test, CERAD Battery and Logical Memory Test (WMSR)"
Time frame: 6 month
1 secondary outcome
changes in speech function and improvement of quality of life
Time frame: 6 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Berg, Doctor principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rivastigmine in people with Progressive Supranuclear Palsy and Dementia, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Berg, Doctor (+49 7071 29 80438, daniela.berg@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in neuropsychological assessments for memory and executive function, e.g. tested by "Tower of London Test, CERAD Battery and Logical Memory Test (WMSR)" (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2008.