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

Parkinsons Disease With Dementia Clinical Trial

Official title:

The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988117
• Other study ID #: CENA7 13D US45T
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2009
• Last updated: January 24, 2014
• Start date: April 2010
• Est. completion date: April 2011

Study information

• Verified date: January 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	UCalifornia SF	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Novartis

Country where clinical trial is conducted

United States, 

References & 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):138 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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).	Baseline and 12 weeks	No

External Links

•   Information about the Memory & Aging Center at UCSF