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

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Bruce Miller, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00988117
First received: September 29, 2009
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Parkinsons Disease With Dementia
Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems
Drug: Rivastigmine Patch 9.5 cm2
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Resting State Functional Activity Change From Baseline to 12 Weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    The Montreal Cognitive Assessment (MoCA) was used as measure of global cognitive function. Total scores range from 0 (worst) to 30 (best).


Enrollment: 15
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988117

Locations
United States, California
UCalifornia SF
San Francisco, California, United States, 94117
Sponsors and Collaborators
University of California, San Francisco
Novartis
Investigators
Principal Investigator: Bruce Miller, M.D. UCalifornia SF
Study Director: Joel Kramer, PsyD UCalifornia SF
  More Information

Additional Information:
Publications:
Responsible Party: Bruce Miller, Director of the Memory & Aging Center, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00988117     History of Changes
Other Study ID Numbers: CENA7 13D US45T
Study First Received: September 29, 2009
Results First Received: July 28, 2013
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Parkinson's Disease with Dementia
Parkinson's Disease
Parkinsons Disease
PDD
rivastigmine
rivastigmine patch
open label
memory
Exelon
Exelon Patch
exelon

Additional relevant MeSH terms:
Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014