Parkinson's DiseasePhase 4NCT00696215
The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease
A Phase 4 study testing rasagiline in people with Parkinson's Disease, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial summary
The objective of the study is to assess the effects of rasagiline on cognitive functions in patient with Parkinson's disease. Patients on any dopaminergic medications will be assigned to receive rasagiline 1 mg or placebo over 3 months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- rasagiline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jun 2007to Oct 2008
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients of any age
- Diagnosis of Idiopathic PD according to the UK Brain Bank Criteria for the clinical diagnosis of PD.
- Patients with cognitive impairment associated with PD, defined as:
- Subjective complaints of impaired cognitive functions such as forgetfulness, word finding difficulties or inattentiveness
- Presence of objectively demonstrable cognitive deficits in at least 2 out of the 4 cognitive domains typically impaired in PD. These include attention, executive functions, memory and visuo-spatial functions. The performance in the following test scores must be 1.5 standard deviations below the mean normative score for age and education of the patient: Digit Span for attention, Letter Fluency test for executive function, Logical Memory Sub-scale from the Wechsler Memory Scale-Revised and Line Orientation Test for visuo-spatial function.
- Patients with a Hoehn and Yahr stage I-III when "on"
- Literate patients who are able to follow test instructions
Who cannot join
- Diagnosis of dementia due to PD according to DSM IV criteria
- Diagnosis of current major depressive episode according to DSM IV criteria
- Presence of any other neurodegenerative disorder other than PD
- Presence of any unstable or untreated systemic disorder such as diabetes, cardiac failure, renal failure
- Use of any prohibited concomitant medication
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Marmara University
Istanbul
NESE TUNCER
- Recruiting
Raif Cakmur
Izmir
RAIF CAKMUR, PROF.DR
About this study
Official title: The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Over 3 Months
The objective of the study is to assess the effects of rasagiline on cognitive functions in patient with Parkinson's disease. Patients on any dopaminergic medications will be assigned to receive rasagiline 1 mg or placebo over 3 months. Cognitive functions will be assessed by selected neuropsychological tests representing each cognitive domain.
Read the detailed description
The primary objective of this study is to assess the effects of rasagiline on cognitive deficits in non-demented patients with PD. The secondary objective is to assess affective changes in this patient population. This will be a randomized, double-blind, placebo controlled study in 1-3 centers. Patients will be recruited from the Movement Disorders Outpatients Clinic, Department of Neurology, Istanbul Faculty of Medicine, Dokuz Eylul University and Marmara University. Eligible patients will be randomly assigned to rasagiline 1 mg or placebo. Patients will be treated with the study medication over 3 months. Cognitive and behavioral assessments will be performed at baseline, at 4 weeks and at the end of the study, at 12 weeks. A total of 40 PD patients with cognitive deficits, but without dementia will be recruited. No sample size calculation will be performed, a sample of convenience will be used.
- Conditions
- Parkinson's Disease
- Being tested
- placebo, rasagiline
- Keywords
- Parkinson's disease, rasagiline, cognition, MAO-B
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Placebo 1 mg once a day
rasagilineDrug
Also called Azilect
1mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: placebo |
| 2 | Active comparator | Rasagiline Receives: Drug: rasagiline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the total cognitive score. This will be calculated by adding the four cognitive sub-scores: attention, executive function, memory and visuo-spatial function.
Measured: 30 months
Secondary outcomes (1)
The four cognitive sub-scores as well as individual tests scores will be analyzed separately. The changes from baseline to the end of the study in the GDS, STAS and UPDRS part III scales will be analyzed.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJun 2007
- Primary completionJun 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Investigators
- MURAT EMRE, PROF, Principal investigator, ISTANBUL FACULTY OF MEDICINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696215
- Sponsor's protocol ID
- 11719A
- Status last verified
- Jun 2008
- First submitted
- 10 Jun 2008
- Last updated
- 12 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Over 3 Months
- ClinicalTrials.gov ID
- NCT00696215
- Acronym / sponsor ID
- 11719A
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, rasagiline, cognition, MAO-B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 12 Jun 2008 (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.
The objective of the study is to assess the effects of rasagiline on cognitive functions in patient with Parkinson's disease. Patients on any dopaminergic medications will be assigned to receive rasagiline 1 mg or placebo over 3 months. Cognitive functions will be assessed by selected neuropsychological tests representing each cognitive domain.
Detailed description
The primary objective of this study is to assess the effects of rasagiline on cognitive deficits in non-demented patients with PD. The secondary objective is to assess affective changes in this patient population. This will be a randomized, double-blind, placebo controlled study in 1-3 centers. Patients will be recruited from the Movement Disorders Outpatients Clinic, Department of Neurology, Istanbul Faculty of Medicine, Dokuz Eylul University and Marmara University. Eligible patients will be randomly assigned to rasagiline 1 mg or placebo. Patients will be treated with the study medication over 3 months. Cognitive and behavioral assessments will be performed at baseline, at 4 weeks and at the end of the study, at 12 weeks. A total of 40 PD patients with cognitive deficits, but without dementia will be recruited. No sample size calculation will be performed, a sample of convenience will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placebo |
| 2 | Active comparator | Drug: rasagilineRasagiline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients of any age
- Diagnosis of Idiopathic PD according to the UK Brain Bank Criteria for the clinical diagnosis of PD.
- Patients with cognitive impairment associated with PD, defined as:
- Patients with a Hoehn and Yahr stage I-III when "on"
- Literate patients who are able to follow test instructions
Key exclusion criteria (5 listed)
- Diagnosis of dementia due to PD according to DSM IV criteria
- Diagnosis of current major depressive episode according to DSM IV criteria
- Presence of any other neurodegenerative disorder other than PD
- Presence of any unstable or untreated systemic disorder such as diabetes, cardiac failure, renal failure
- Use of any prohibited concomitant medication
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 |
|---|---|---|
| placeboPlacebo 1 mg once a day | Drug | 1 |
| rasagilineAlso: Azilect1mg | Drug | 2 |
Primary outcome
The primary outcome measure will be the total cognitive score. This will be calculated by adding the four cognitive sub-scores: attention, executive function, memory and visuo-spatial function.
Time frame: 30 months
1 secondary outcome
The four cognitive sub-scores as well as individual tests scores will be analyzed separately. The changes from baseline to the end of the study in the GDS, STAS and UPDRS part III scales will be analyzed.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2008.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
MURAT EMRE, PROF principal investigator
ISTANBUL FACULTY OF MEDICINE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rasagiline in people with Parkinson's Disease, run by Istanbul University at 2 sites in Turkey (Türkiye).
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 7 inclusion and 5 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 12 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 MURAT EMRE, PROF. DR (90-21-2533-8575, muratemre@superonline.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure will be the total cognitive score. This will be calculated by adding the four cognitive sub-scores: attention, executive function, memory and visuo-spatial function. (time frame: 30 months). 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 12 Jun 2008.