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

January 24, 2014 updated by: Bruce Miller, University of California, San Francisco

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94117
        • UCalifornia SF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rivastigmine Patch 9.5 cm2
Drug: Rivastigmine Patch 9.5 cm2
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pre-post Change in Montreal Cognitive Assessment
Time Frame: Baseline and 12 weeks
The Montreal Cognitive Assessment (MoCA) was used as measure of global cognitive function. Total scores range from 0 (worst) to 30 (best).
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novartis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bruce Miller, M.D., UCalifornia SF
  • Study Director: Joel Kramer, PsyD, UCalifornia SF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CENA7 13D US45T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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