Parkinsons Disease With DementiaPhase 4NCT00988117

The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking Problems

A Phase 4 study testing Rivastigmine Patch 9.5 cm2 in people with Parkinsons Disease With Dementia and Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 years and older
Conditions the study is for: Parkinsons Disease With Dementia, Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems
What is being tested?: Rivastigmine Patch 9.5 cm2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Apr 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must meet research criteria for Parkinson's Disease with Dementia (PDD)
Males and females, ages between 55 and 100
Able to undergo psychometric testing
Mini-Mental State Examination ≥ 21 and Clinical Dementia Rating < 2
Reliable informant with frequent contact with patient

Who cannot join

Non-English speaking, as cognitive tests will be in English
Evidence of other neurological or psychiatric disorders which preclude diagnosis of PDD (including, but not limited to, stroke, any psychotic disorder, severe bipolar or unipolar depression, seizure disorder, or head injury with loss of consciousness) within the past year
Concurrent treatment with any acetylcholinesterase inhibitors (including rivastigmine in pill or patch form), antipsychotic agents (excluding quetiapine in dosages of 150 mg and lower, abilify and geodon as these medications are commonly used in treatment of Parkinson's Disease (PD) psychosis and should not affect results of study), mood stabilizers (valproate or lithium) or benzodiazepines (other than temazepam or zolpidem)
Positive urine drug screen or suspected alcohol or substance abuse within last 1 year
Current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included
Systolic blood pressure over 180 or less than 90 mm Hg. Diastolic blood pressure not greater than 105 or less than 50 mm Hg

Show all 10Show fewer

ECG is abnormal and judged to be clinically significant by the investigator
Use of investigational drugs or participation in investigational drug studies within 30 days of screening
Geriatric Depression Score score > 15/30
Hachinski score > 4

Trial locations and contacts

1 site in 1 country.

United States1 site

UCalifornia SF
San Francisco, California, 94117

Other trials in United States

About this study

Official title: The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD)

This is an open-label study to investigate the effects of the rivastigmine patch on attention and behavior in Parkinson's disease when associated with memory and/or thinking problems. Rivastigmine (also sold under the name Exelon) is an FDA approved medication used for the treatment of mild to moderate Alzheimer's Disease (AD) and memory or thinking problems due to Parkinson's disease. Recently a rivastigmine patch was developed, which has shown similar effectiveness with fewer side effects and increased caregiver preference when compared to capsules. This is an open-label 12 week study where 15 subjects diagnosed with Parkinson's Disease who have mild to moderate memory and/or thinking complaints will be treated with the rivastigmine patch at UCSF. This study also analyzes the mechanism by which the rivastigmine patch works in people with Parkinson's disease and memory and/or thinking problems.

Read the detailed description

Participation in this study requires four visits: a screening visit to ensure eligibility, an initial/baseline visit where the medication is distributed at a dosage lower than the optimal recommended dosage, a four week follow-up visit where the dosage of the medication is increased to the optimal amount, and a final twelve week follow up visit.

In the screening visit the patient will undergo a neurological exam (including a review of their medical history and short physical exam), electrocardiogram ( a painless procedure that measures electrical activity of your heart), cognitive testing (such as memory and thinking tests), and a blood draw.
At the Baseline/Initial visit the patient will receive a brief physical exam, additional cognitive testing, and an MRI scan. Afterwards, the study drug will be distributed.
At the four week follow up visit the patient will be asked to do some abbreviated cognitive and neurological testing and the study drug will be re-distributed at the target dosage.
At the final twelve week visit the patient will receive additional cognitive and neurological testing, and an MRI scan.
Study compliance and adverse events will be reviewed every two weeks throughout the study, whether in person or over the phone.

Conditions: Parkinsons Disease With Dementia, Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems
Being tested: Rivastigmine Patch 9.5 cm2
Keywords: PDD, Parkinson's Disease with Dementia, rivastigmine, rivastigmine patch, open label, Parkinson's Disease, Parkinsons Disease, memory, Exelon, Exelon Patch
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rivastigmine Patch 9.5 cm2Drug
Subjects will be started on a 5cm2/24hr rivastigmine patch. After 4 weeks, the dose will be increased to a recommended target dose of 9.5cm2/24hr patch for 8 additional weeks.

Study groups in NCT00988117
Study group	Role	What they receive
Rivastigmine Patch 9.5 cm2	Experimental	Not described Receives: Drug: Rivastigmine Patch 9.5 cm2

What is being measured

The primary outcome is the main question the study is designed to answer.

Resting State Functional Activity Change From Baseline to 12 Weeks
Fractional amplitude of low frequency fluctuations (fALFF) was used to measure brain activity. This metric is derived from task-free functional magnetic resonance imaging (fMRI) and represents the power of regional spontaneous and intrinsic brain activity at the local, voxel-wise level while the subject is at rest. More specifically, the amplitude of low-frequency fluctuations (ALFF) is the total power in the low-frequency range, and fALFF is calculated by dividing ALFF by the total power across all measurable frequencies. Whereas ALFF values increase near blood vessels and cerebrospinal fluid (CSF), likely due to pulsations in those areas, fALFF is less susceptible to artifactual signals. We measured change in these ratio scores post-treatment minus baseline and present in z-score units.
Measured: Baseline and 12 weeks
Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time)
On the Continuous Performance Test (CPT), subjects press the spacebar quickly when they see a target image (a white star; 150 trials), and withhold response when they see a non-target image (5 randomly sampled white shapes; 150 trials). The inter-stimulus interval is randomly sampled from 1.5s, 2.5s, or 4s. Performance is measured by the median reaction time (milliseconds) on accurate target trials.
Measured: Baseline and 12 weeks

Secondary outcomes (1)

Pre-post Change in Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) was used as measure of global cognitive function. Total scores range from 0 (worst) to 30 (best).
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Apr 2011

First posted1 Oct 2009 (estimated)
Study startApr 2010
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Parkinsons Disease With DementiaStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00988117
Sponsor's protocol ID: CENA7 13D US45T
Status last verified: Jan 2014
First submitted: 29 Sep 2009
Last updated: 26 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Possin KL, Kang GA, Guo C, Fine EM, Trujillo AJ, Racine CA, Wilheim R, Johnson ET, Witt JL, Seeley WW, Miller BL, Kramer JH. Rivastigmine is associated with restoration of left frontal brain activity in Parkinson's disease. Mov Disord. 2013 Sep;28(10):1384-90. doi: 10.1002/mds.25575. Epub 2013 Jul 11.
PubMed 23847120

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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[18F]ACI-15916 PET in α-synucleinopathies
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Not yet recruiting
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All Parkinsons Disease With Dementia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD)
ClinicalTrials.gov ID: NCT00988117
Acronym / sponsor ID: CENA7 13D US45T
Conditions: Parkinsons Disease With Dementia, Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems
Keywords: PDD, Parkinson's Disease with Dementia, rivastigmine, rivastigmine patch, open label, Parkinson's Disease, Parkinsons Disease, memory
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: Novartis
Study start: Apr 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 1 Oct 2009 (estimated)
Results: Posted 26 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In the screening visit the patient will undergo a neurological exam (including a review of their medical history and short physical exam), electrocardiogram ( a painless procedure that measures electrical activity of your heart), cognitive testing (such as memory and thinking tests), and a blood draw.
At the Baseline/Initial visit the patient will receive a brief physical exam, additional cognitive testing, and an MRI scan. Afterwards, the study drug will be distributed.
At the four week follow up visit the patient will be asked to do some abbreviated cognitive and neurological testing and the study drug will be re-distributed at the target dosage.
At the final twelve week visit the patient will receive additional cognitive and neurological testing, and an MRI scan.
Study compliance and adverse events will be reviewed every two weeks throughout the study, whether in person or over the phone.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rivastigmine Patch 9.5 cm2	Experimental	Drug: Rivastigmine Patch 9.5 cm2

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Must meet research criteria for Parkinson's Disease with Dementia (PDD)
Males and females, ages between 55 and 100
Able to undergo psychometric testing
Mini-Mental State Examination ≥ 21 and Clinical Dementia Rating < 2
Reliable informant with frequent contact with patient

Key exclusion criteria (10 listed)

Non-English speaking, as cognitive tests will be in English
Evidence of other neurological or psychiatric disorders which preclude diagnosis of PDD (including, but not limited to, stroke, any psychotic disorder, severe bipolar or unipolar depression, seizure disorder, or head injury with loss of consciousness) within the past year
Concurrent treatment with any acetylcholinesterase inhibitors (including rivastigmine in pill or patch form), antipsychotic agents (excluding quetiapine in dosages of 150 mg and lower, abilify and geodon as these medications are commonly used in treatment of Parkinson's Disease (PD) psychosis and should not affect results of study), mood stabilizers (valproate or lithium) or benzodiazepines (other than temazepam or zolpidem)
Positive urine drug screen or suspected alcohol or substance abuse within last 1 year
Current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included

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
Rivastigmine Patch 9.5 cm2Subjects will be started on a 5cm2/24hr rivastigmine patch. After 4 weeks, the dose will be increased to a recommended target dose of 9.5cm2/24hr patch for 8 additional weeks.	Drug	Rivastigmine Patch 9.5 cm2

Primary outcome

Resting State Functional Activity Change From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
Fractional amplitude of low frequency fluctuations (fALFF) was used to measure brain activity. This metric is derived from task-free functional magnetic resonance imaging (fMRI) and represents the power of regional spontaneous and intrinsic brain activity at the local, voxel-wise level while the subject is at rest. More specifically, the amplitude of low-frequency fluctuations (ALFF) is the total power in the low-frequency range, and fALFF is calculated by dividing ALFF by the total power across all measurable frequencies. Whereas ALFF values increase near blood vessels and cerebrospinal fluid (CSF), likely due to pulsations in those areas, fALFF is less susceptible to artifactual signals. We measured change in these ratio scores post-treatment minus baseline and present in z-score units.
Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time)
Time frame: Baseline and 12 weeks
On the Continuous Performance Test (CPT), subjects press the spacebar quickly when they see a target image (a white star; 150 trials), and withhold response when they see a non-target image (5 randomly sampled white shapes; 150 trials). The inter-stimulus interval is randomly sampled from 1.5s, 2.5s, or 4s. Performance is measured by the median reaction time (milliseconds) on accurate target trials.

1 secondary outcome

Pre-post Change in Montreal Cognitive Assessment
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 26 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rivastigmine	15	14

Primary outcome: Resting State Functional Activity Change From Baseline to 12 Weeks

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: z-score

Measure	Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours n = 12
left inferior frontal gyrus / premotor fALFF chang	1.13 (1)
left supplementary motor area fALFF change	.79 (1)

Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours: Tscore: 5.19, p <0.01, t-test, 2 sided

Population analysed: All patients who completed the study were included.

Primary outcome: Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time)

Time frame: Baseline and 12 weeks. Median (Full Range). Unit: milliseconds

Measure	Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours n = 10
Baseline	579 (108)
Post-treatment	571 (108)

Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours: pearson's r correlation coefficient: -.82, p <.01, Regression, Linear
Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours: pearson's correlation coefficient: -.35, p = .36, Regression, Linear

Population analysed: Data were missing for two of the patients on the CPT post-treatment due to a computer error.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rivastigmine 4.6mg/24 Hours	0 of 15 (0%)	1 of 15 (6.7%)	Not reported
Rivastigmine 9.5 mg/24 Hours	0 of 14 (0%)	2 of 14 (14.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23847120Possin KL, Kang GA, Guo C, Fine EM, Trujillo AJ, Racine CA, Wilheim R, Johnson ET, Witt JL, Seeley WW, Miller BL, Kramer JH. Rivastigmine is associated with restoration of left frontal brain activity in Parkinson's disease. Mov Disord. 2013 Sep;28(10):1384-90. doi: 10.1002/mds.25575. Epub 2013 Jul 11.
Information about the Memory \& Aging Center at UCSFLink provided by the sponsor.

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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.

Bruce Miller, M.D. principal investigator

UCalifornia SF

Joel Kramer, PsyD study director

UCalifornia SF

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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: finished, as of the sponsor's last update on 26 Feb 2014. 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. 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?

Yes. Results are posted in the registry (first posted 26 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Resting State Functional Activity Change From Baseline to 12 Weeks (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00988117, which also lists 1 linked publication.

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 26 Feb 2014.