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

NCT00988117 | Completed Phase 4 Results DMC

• 1 other identifier: CENA7 13D US45T
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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; Exelon; Exelon Patch

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Pre-post Change in Montreal Cognitive Assessment

  Baseline and 12 weeks

Study Arms (1)

Rivastigmine Patch 9.5 cm2

EXPERIMENTAL

Drug: Rivastigmine Patch 9.5 cm2

Interventions

Rivastigmine Patch 9.5 cm2 DRUG

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.

Rivastigmine Patch 9.5 cm2

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Novartis: collaborator

Study Sites (1)

UCalifornia SF

San Francisco, California, 94117, United States

Location

Related Publications (1)

• 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.

  PMID: 23847120 RESULT

Related Links

• Information about the Memory \& Aging Center at UCSF

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Bruce Miller
• Organization: UCaliforniaSF

bmiller@memory.ucsf.edu; kpossin@memory.ucsf.edu

415-476-5569

Study Officials

• Bruce Miller, M.D.

  UCalifornia SF

  PRINCIPAL INVESTIGATOR

• Joel Kramer, PsyD

  UCalifornia SF

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Memory & Aging Center

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: October 1, 2009
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 26, 2014
• Results First Posted: February 26, 2014

Record last verified: 2014-01

Locations

US (1)