Parkinson's DiseasePhase 4NCT01382342
The Effect of Rasagiline on Cognition in Parkinson's Disease
A Phase 4 study testing Rasagiline in people with Parkinson's Disease, run by Brown University at 1 site in United States.
Trial summary
While Parkinson's disease has historically been defined in terms of its motor symptomatology, studies have shown that non-motor deficits form an important part of the syndrome. Cognitive deficits can occur even in the early stages of Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- 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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Feb 2014
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 40 or older
- able to speak and read English, at least 6 years of formal education
- a diagnosis of PD
- have a family member or caregiver willing to fill out study questionnaires
- Participants will have been on stable medication regimens (no new PD medications and no changes to existing PD medication dosages) for the 4 weeks prior to study enrollment.
- If participants are already taking other Parkinson's medications at time of study enrollment, the dosages of these medications must remain stable throughout study participation.
- Changes to existing Parkinson's disease medications dosages or addition of other medications to treat Parkinson's disease after study enrollment will result in removal from study.
- Participants are allowed to begin non-PD medications or to have changes to their existing non-PD medications if these additions and changes are deemed medically necessary.
Who cannot join
- currently taking any MAO inhibitor
- currently taking a cognition-enhancing medication such as a cholinesterase inhibitor medication or memantine
- dementia (Mini-Mental Status Exam score below 21/30), significant depression (Beck Depression Inventory- Short Form score >7)
- presence of a another neurodegenerative disorder besides PD
- unstable cardiac disorder, clinically significant hepatic
- lung or renal disease
- In addition, changes to dosages of PD-related medications or the addition of other PD medications during the 6 month study enrollment will result in dismissal from the study.
Trial locations and contacts
1 site in 1 country.
About this study
While Parkinson's disease has historically been defined in terms of its motor symptomatology, studies have shown that non-motor deficits form an important part of the syndrome. Cognitive deficits can occur even in the early stages of Parkinson's disease. These deficits are often subtle and do not rise to the level of impairment necessary for a diagnosis of dementia; however these deficits are discernable with neuropsychological testing and may produce subjective complaints of cognitive decline and mild functional difficulties in some patients. The traditional pharmacological interventions for Parkinson's disease have focused on controlling and alleviating motor symptoms with levodopa and dopamine agonists. However, these medications treat the symptoms of PD, but do not alter the course or progression of the underlying disorder. In contrast, rasagiline, an MAO-B inhibitor, has recently shown benefits consistent with a possible disease-modifying effect. Given the positive and intriguing findings seen with treatment with rasagiline, the investigators propose to study the effects of this medication on cognition in patients with mild to moderate stage Parkinson's disease.
Hypotheses:
- Rasagiline will improve cognitive function, as measured by performance on neuropsychological tests in PD patients who do not suffer from dementia.
- Rasagiline will not negatively affect neuropsychiatric functioning.
Read the detailed description
The results of our study found that while participants receiving rasagiline showed some improvements in their motor symptoms, as measured by the UPDRS, no significant changes were found on any of the neuropsychological measures after six months of treatment with rasagiline. Further, the participant group who received placebo also did not show significant change on any of the neuropsychological measures over the six month course of our study. Finally, the cognitive performance of our treatment and placebo groups did not differ significantly from one another at baseline or after six months of study participation.
- Conditions
- Parkinson's Disease
- Being tested
- Rasagiline, Placebo
- Keywords
- Parkinson's disease, cognition, executive function, rasagiline
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RasagilineDrug
Also called Azilect
1 mg daily
PlaceboDrug
1 mg daily
| Study group | Role | What they receive |
|---|---|---|
| rasagiline | Experimental | Participants in this arm will receive 1 mg of rasagiline daily for the six month duration of the study. Receives: Drug: Rasagiline |
| Placebo | Placebo comparator | Participants in this group will receive 1 mg of placebo daily for the six month duration of the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rey Auditory Verbal Learning Test
This is a 15 item supraspan verbal memory test. This measure assesses immediate memory span, new learning, susceptibility to interference, retention, and recognition memory.
Measured: Change in score from day 1 of study enrollment and score after 6 months of treatment
Secondary outcomes (7)
Controlled Oral Word Association Test
This test evaluates the spontaneous production of words beginning with a given letter of the alphabet under timed conditions. It is used to assess executive functioning.
Measured: day 1 of study enrollment and after 6 months of treatment
Animal Fluency
Participants are asked to produce as many animal names as they can in one minute. This measure assesses executive functioning.
Measured: day 1 of study enrollment and after 6 months of treatment
Judgement of Line Orientation from the Repeat Battery for the Assessment of Neuropsychological Status
This measure assesses spatial perception and orientation without requiring a motor output.
Measured: day 1 of study enrollment and after 6 months of treatment
Digit Span from the Wechsler Adult Intelligence Scale- Fourth Edition
This is a measure of attention and working memory which requires participants to repeat a series of digits forward, in reverse, and to sequence a series of digits.
Measured: day 1 of study enrollment and after 6 months of treatment
Trail Making Test
These are tests of speed for attention, sequencing, mental flexibility, and visual search.
Measured: day 1 of study enrollment and after 6 months of treatment
Digit Symbol Modalities Test
This test assesses cognitive processing speed, and visuomotor coordination and is one of the most sensitive measures of cognitive dysfunction available.
Measured: day 1 of study enrollment and after 6 months of treatment
Parkinson's Disease Quality of Life Questionnaire
The 39-item Parkinson's disease questionnaire (PDQ-39) is one of the most often used instruments to measure treat¬ment effect on quality of life in PD.
Measured: day 1 of study enrollment and after 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2014
- Study completionFeb 2014
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 Brown 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Principal investigator, Laura L. Frakey, Brown University
- Investigators
- Laura L. Frakey, Ph.D., Principal investigator, Brown UniversityJoseph Friedman, MD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382342
- Sponsor's protocol ID
- TNSAZL0016
- Status last verified
- Feb 2015
- First submitted
- 23 Jun 2011
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rasagiline on Cognition in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01382342
- Acronym / sponsor ID
- TNSAZL0016
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, cognition, executive function, rasagiline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- Jun 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Jun 2011 (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.
While Parkinson's disease has historically been defined in terms of its motor symptomatology, studies have shown that non-motor deficits form an important part of the syndrome. Cognitive deficits can occur even in the early stages of Parkinson's disease. These deficits are often subtle and do not rise to the level of impairment necessary for a diagnosis of dementia; however these deficits are discernable with neuropsychological testing and may produce subjective complaints of cognitive decline and mild functional difficulties in some patients. The traditional pharmacological interventions for Parkinson's disease have focused on controlling and alleviating motor symptoms with levodopa and dopamine agonists. However, these medications treat the symptoms of PD, but do not alter the course or progression of the underlying disorder. In contrast, rasagiline, an MAO-B inhibitor, has recently shown benefits consistent with a possible disease-modifying effect. Given the positive and intriguing findings seen with treatment with rasagiline, the investigators propose to study the effects of this medication on cognition in patients with mild to moderate stage Parkinson's disease.
Hypotheses:
- Rasagiline will improve cognitive function, as measured by performance on neuropsychological tests in PD patients who do not suffer from dementia.
- Rasagiline will not negatively affect neuropsychiatric functioning.
Detailed description
The results of our study found that while participants receiving rasagiline showed some improvements in their motor symptoms, as measured by the UPDRS, no significant changes were found on any of the neuropsychological measures after six months of treatment with rasagiline. Further, the participant group who received placebo also did not show significant change on any of the neuropsychological measures over the six month course of our study. Finally, the cognitive performance of our treatment and placebo groups did not differ significantly from one another at baseline or after six months of study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rasagiline | Experimental | Drug: RasagilineParticipants in this arm will receive 1 mg of rasagiline daily for the six month duration of the study. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this group will receive 1 mg of placebo daily for the six month duration of the study. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 40 or older
- able to speak and read English, at least 6 years of formal education
- a diagnosis of PD
- have a family member or caregiver willing to fill out study questionnaires
- Participants will have been on stable medication regimens (no new PD medications and no changes to existing PD medication dosages) for the 4 weeks prior to study enrollment.
Key exclusion criteria (7 listed)
- currently taking any MAO inhibitor
- currently taking a cognition-enhancing medication such as a cholinesterase inhibitor medication or memantine
- dementia (Mini-Mental Status Exam score below 21/30), significant depression (Beck Depression Inventory- Short Form score >7)
- presence of a another neurodegenerative disorder besides PD
- unstable cardiac disorder, clinically significant hepatic
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 |
|---|---|---|
| RasagilineAlso: Azilect1 mg daily | Drug | rasagiline |
| Placebo1 mg daily | Drug | Placebo |
Primary outcome
Rey Auditory Verbal Learning Test
Time frame: Change in score from day 1 of study enrollment and score after 6 months of treatment
This is a 15 item supraspan verbal memory test. This measure assesses immediate memory span, new learning, susceptibility to interference, retention, and recognition memory.
7 secondary outcomes
Controlled Oral Word Association Test
Time frame: day 1 of study enrollment and after 6 months of treatment
Animal Fluency
Time frame: day 1 of study enrollment and after 6 months of treatment
Judgement of Line Orientation from the Repeat Battery for the Assessment of Neuropsychological Status
Time frame: day 1 of study enrollment and after 6 months of treatment
Digit Span from the Wechsler Adult Intelligence Scale- Fourth Edition
Time frame: day 1 of study enrollment and after 6 months of treatment
Trail Making Test
Time frame: day 1 of study enrollment and after 6 months of treatment
Digit Symbol Modalities Test
Time frame: day 1 of study enrollment and after 6 months of treatment
Parkinson's Disease Quality of Life Questionnaire
Time frame: day 1 of study enrollment and after 6 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
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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.
Laura L. Frakey, Ph.D. principal investigator
Brown University
Joseph Friedman, MD principal investigator
Brown University
1 site 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 Brown University at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 5 Feb 2015. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rey Auditory Verbal Learning Test (time frame: Change in score from day 1 of study enrollment and score after 6 months of treatment). 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 5 Feb 2015.