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

Primary Purpose

Parkinsons Disease With Dementia, Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rivastigmine Patch 9.5 cm2
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinsons Disease With Dementia focused on measuring PDD, Parkinson's Disease with Dementia, rivastigmine, rivastigmine patch, open label, Parkinson's Disease, Parkinsons Disease, memory, Exelon, Exelon Patch

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • UCalifornia SF

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rivastigmine Patch 9.5 cm2

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).

Full Information

First Posted
September 29, 2009
Last Updated
January 24, 2014
Sponsor
University of California, San Francisco
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00988117
Brief Title
The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking Problems
Official Title
The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Exelon, Exelon Patch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivastigmine Patch 9.5 cm2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rivastigmine Patch 9.5 cm2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Resting State Functional Activity Change From Baseline to 12 Weeks
Description
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.
Time Frame
Baseline and 12 weeks
Title
Pre-post Change in Continuous Performance Test of Attention (Median Reaction Time)
Description
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.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Pre-post Change in Montreal Cognitive Assessment
Description
The Montreal Cognitive Assessment (MoCA) was used as measure of global cognitive function. Total scores range from 0 (worst) to 30 (best).
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Miller, M.D.
Organizational Affiliation
UCalifornia SF
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joel Kramer, PsyD
Organizational Affiliation
UCalifornia SF
Official's Role
Study Director
Facility Information:
Facility Name
UCalifornia SF
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23847120
Citation
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.
Results Reference
result
Links:
URL
http://memory.ucsf.edu/
Description
Information about the Memory & Aging Center at UCSF

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

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