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

Sponsor:	University of California, San Francisco
Collaborator:	Novartis
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00988117

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 IV

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:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease Perry syndrome

MedlinePlus related topics: Anxiety Dementia Memory Parkinson's Disease

Drug Information available for: Rivastigmine SDZ-ENA 713

U.S. FDA Resources

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

Primary Outcome Measures:

Resting state functional network activity (degree of fit in the dorsolateral frontal-parietal network) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
The Attention Network Test (overall reaction time) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Fluctuations in attention (One Day Fluctuation Assessment Scale) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Neuropsychiatric symptoms (Neuropsychiatric Inventory total score) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in everyday functions (Functional Assessment Questionnaire) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Caregiver assessment of cognitive and functional changes (Clinical Dementia Rating) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Assessment of depression (Geriatric Depression Scale) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Assessment of anxiety levels (Beck Anxiety Inventory) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Assessment of global decline (Clinical Global Impression of Change) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	November 2009
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (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 intial/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.
At each visit the study partner will be asked to complete an interview and questionnaires about the patient's memory and thinking.
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 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

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:

Information about the Memory & Aging Center at UCSF This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bruce Miller, M.D. / Director of the Memory & Aging Center, UCSF, UCalifornia SF
ClinicalTrials.gov Identifier:	NCT00988117 History of Changes
Other Study ID Numbers:	CENA7 13D US45T
Study First Received:	September 29, 2009
Last Updated:	February 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:

PDD
Parkinson's Disease with Dementia
rivastigmine
rivastigmine patch
open label
Parkinson's Disease

Parkinsons Disease
memory
Exelon
Exelon Patch
exelon

Additional relevant MeSH terms:

Dementia
Parkinson Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases
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 February 09, 2012