Parkinson's DiseasePhase 4NCT01519271
Mild Cognitive Impairment in Parkinson's Disease
A Phase 4 study testing Exelon Patch (rivastigmine transdermal system) in people with Parkinson's Disease and Mild Cognitive Impairment, run by University of Pennsylvania at 1 site in United States.
Trial summary
Mild cognitive impairment, including difficulty with solving problems, planning, attention, or recalling information, can be a significant problem for individuals with Parkinson's disease. Even mild cognitive difficulties can lead to worse functioning, quality of life, depression, and difficulty for caregivers. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson's Disease, Mild Cognitive Impairment
- What is being tested?
- Exelon Patch (rivastigmine transdermal system)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jun 2014
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be experiencing symptoms of mild cognitive impairment; this will be determined by study personnel.
- Participants must be on a sable medication regimen for 2 months prior to starting the study (necessary dose adjustments during the study are acceptable).
- Participants are capable of giving informed consent supported by not meeting Parkinson's disease Dementia criteria; this will be determined by study personnel.
Who cannot join
- Active suicide ideation.
- Weighing less than 100 lbs (45 kgs).
- History of Deep Brain Stimulation surgery.
- Diagnosis of Dementia
- Taking certain types of medications may be an exclusion criteria, this will be reviewed with all potential participants.
- Females that are pregnant, planning to become pregnant, or are breastfeeding will not be included in the study. Females of childbearing potential will need to verify that they are not pregnant by a negative urine pregnancy test.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Ralston House
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase IV Randomized, Double-Blind, Placebo-Controlled, Crossover Single Site Study Of Exelon® Patch (Rivastigmine Transdermal System) For Mild Cognitive Impairment In Parkinson's Disease
Mild cognitive impairment, including difficulty with solving problems, planning, attention, or recalling information, can be a significant problem for individuals with Parkinson's disease. Even mild cognitive difficulties can lead to worse functioning, quality of life, depression, and difficulty for caregivers. Thus, ideally treatment at this stage would improve both cognitive symptoms and some of the other problems associated with these symptoms.
Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease patients little is known about how best to treat it. This study is a 24-week clinical trial to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine) Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease. Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to moderate dementia in Alzheimer and Parkinson's disease patients.
Read the detailed description
This study has 2 phases. Each phase will last 10 weeks and there will be a 4-week break between the 2 phases. Thus, you will be enrolled in the study for a total of 24 weeks. Over the course of the 24-week period we will schedule to see you in-person 6 times and check-in with you on the telephone 4 times, 2 times during each phase.
Phase I
Screening (may be the same day as the baseline visit) - Research personnel will determine if you are eligible to participate in this study.
Visit 1 - Baseline Visit, Start Study Medication
Phone Call 1 - Check in to see how you are feeling after starting the study medication
Visit 2 - 4 Weeks after Baseline, Increase Study Medication if tolerated
Phone Call 2 - Check in to see how you are feeling after increasing the study medication
Visit 3/ Phase I Termination Visit - 10 Weeks after Baseline (Phase I Termination Visit)
4 Week Break (no study medication)
Phase II
Visit 4/ Phase II Baseline - 14 Weeks after Baseline, Start Study Medication
Phone Call 3 - Check in to see how you are feeling after starting the study medication
Visit 5 - 18 Weeks after Baseline, Increase Study Medication
Phone Call 4 - Check in to see how you are feeling after increasing the study medication
Visit 6/Phase II and Study Termination Visit - 24 Weeks after Baseline
Visits 1, 3, 4, and 6 will last for about 2 ½ hours and visits 2 and 5 about 30 minutes. The 'check in' phone calls will last approximately 5-10 minutes.
After 24 weeks, your study participation will be over.
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Being tested
- Exelon Patch (rivastigmine transdermal system), Placebo Patches
- Keywords
- Parkinson's Disease, Mild Cognitive Impairment, Cognition, Memory, Attention, Exelon, Rivastigmine
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exelon Patch (rivastigmine transdermal system)Drug
The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.
5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )
Placebo PatchesDrug
The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
| Study group | Role | What they receive |
|---|---|---|
| Placebo Patch | Placebo comparator | Not described Receives: Drug: Placebo Patches |
| Exelon Patch (rivastigmine transdermal system) | Active comparator | Not described Receives: Drug: Exelon Patch (rivastigmine transdermal system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)
The ADCS-CGIC is the most commonly used measure of global change in dementia psychopharmacology studies. This assessment is a measure of change, thus it is not appropriate for baseline administration and only administered at the end of phase visit.
The scale rates total improvement on a 7 point scale:
- = Very much improved
- = Much improved
- = Minimally improved
- = No change
- = Minimally worse
- = Much worse
- = Very much worse
A participant scoring a 1 or 2 is considered a responder on the CGI scale.
Measured: The ADCS-CGIC will be administered at the end of each study phase.
Secondary outcomes (1)
Montreal Cognitive Assessment (MoCA)
The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.
Measured: The MoCA was administered in the beginning and end of each study phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2014
- Study completionJun 2014
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.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Weintraub, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519271
- Sponsor's protocol ID
- 813803
- Status last verified
- Feb 2017
- First submitted
- 10 Jan 2012
- Last updated
- 7 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Randomized, Double-Blind, Placebo-Controlled, Crossover Single Site Study Of Exelon® Patch (Rivastigmine Transdermal System) For Mild Cognitive Impairment In Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01519271
- Acronym / sponsor ID
- 813803
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Keywords
- Parkinson's Disease, Mild Cognitive Impairment, Cognition, Memory, Attention, Exelon, Rivastigmine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Posted 7 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mild cognitive impairment, including difficulty with solving problems, planning, attention, or recalling information, can be a significant problem for individuals with Parkinson's disease. Even mild cognitive difficulties can lead to worse functioning, quality of life, depression, and difficulty for caregivers. Thus, ideally treatment at this stage would improve both cognitive symptoms and some of the other problems associated with these symptoms.
Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease patients little is known about how best to treat it. This study is a 24-week clinical trial to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine) Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease. Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to moderate dementia in Alzheimer and Parkinson's disease patients.
Detailed description
This study has 2 phases. Each phase will last 10 weeks and there will be a 4-week break between the 2 phases. Thus, you will be enrolled in the study for a total of 24 weeks. Over the course of the 24-week period we will schedule to see you in-person 6 times and check-in with you on the telephone 4 times, 2 times during each phase.
Phase I
Screening (may be the same day as the baseline visit) - Research personnel will determine if you are eligible to participate in this study.
Visit 1 - Baseline Visit, Start Study Medication
Phone Call 1 - Check in to see how you are feeling after starting the study medication
Visit 2 - 4 Weeks after Baseline, Increase Study Medication if tolerated
Phone Call 2 - Check in to see how you are feeling after increasing the study medication
Visit 3/ Phase I Termination Visit - 10 Weeks after Baseline (Phase I Termination Visit)
4 Week Break (no study medication)
Phase II
Visit 4/ Phase II Baseline - 14 Weeks after Baseline, Start Study Medication
Phone Call 3 - Check in to see how you are feeling after starting the study medication
Visit 5 - 18 Weeks after Baseline, Increase Study Medication
Phone Call 4 - Check in to see how you are feeling after increasing the study medication
Visit 6/Phase II and Study Termination Visit - 24 Weeks after Baseline
Visits 1, 3, 4, and 6 will last for about 2 ½ hours and visits 2 and 5 about 30 minutes. The 'check in' phone calls will last approximately 5-10 minutes.
After 24 weeks, your study participation will be over.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Patch | Placebo comparator | Drug: Placebo Patches |
| Exelon Patch (rivastigmine transdermal system) | Active comparator | Drug: Exelon Patch (rivastigmine transdermal system) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be experiencing symptoms of mild cognitive impairment; this will be determined by study personnel.
- Participants must be on a sable medication regimen for 2 months prior to starting the study (necessary dose adjustments during the study are acceptable).
- Participants are capable of giving informed consent supported by not meeting Parkinson's disease Dementia criteria; this will be determined by study personnel.
Key exclusion criteria (6 listed)
- Active suicide ideation.
- Weighing less than 100 lbs (45 kgs).
- History of Deep Brain Stimulation surgery.
- Diagnosis of Dementia
- Taking certain types of medications may be an exclusion criteria, this will be reviewed with all potential participants.
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 |
|---|---|---|
| Exelon Patch (rivastigmine transdermal system)The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia. 5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours ) | Drug | Exelon Patch (rivastigmine transdermal system) |
| Placebo PatchesThe placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine). | Drug | Placebo Patch |
Primary outcome
Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)
Time frame: The ADCS-CGIC will be administered at the end of each study phase.
The ADCS-CGIC is the most commonly used measure of global change in dementia psychopharmacology studies. This assessment is a measure of change, thus it is not appropriate for baseline administration and only administered at the end of phase visit. The scale rates total improvement on a 7 point scale: 1. = Very much improved 2. = Much improved 3. = Minimally improved 4. = No change 5. = Minimally worse 6. = Much worse 7. = Very much worse A participant scoring a 1 or 2 is considered a responder on the CGI scale.
1 secondary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: The MoCA was administered in the beginning and end of each study phase.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Published Study AbstractLink 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.
Daniel Weintraub, MD principal investigator
University of Pennsylvania
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 Exelon Patch (rivastigmine transdermal system) in people with Parkinson's Disease and Mild Cognitive Impairment, run by University of Pennsylvania 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 3 inclusion and 6 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 7 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 7 Apr 2017). 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?
Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC) (time frame: The ADCS-CGIC will be administered at the end of each study phase.). 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 7 Apr 2017.