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

16:40 EDT 25th October 2014 | BioPortfolio

Summary

This is an open-label study to investigate the effects of the rivastigmine patch on attention and behavior in Parkinson's disease with Dementia (PDD). Rivastigmine is an FDA approved medication used for the treatment of mild to moderate Alzheimer's Disease (AD) and dementia 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 for the treatment of AD, but has had poor documentation when tested in PDD. This is an open-label 12 week study where 15 subjects diagnosed with PDD (people who have known Parkinson's Disease and 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 PDD.

Description

Upon referral to this study, subjects will undergo screening to ensure they meet inclusion criteria. At screening, participants will undergo an interview (prior medical & psychiatric history), neuropsychological testing, and physical & neurological exam, including UPDRS to measure parkinsonian symptoms and Hachinski score to measure cerebrovascular disease. At the end of the screening visit, the neurologist will evaluate whether the participant meets PDD research criteria and will also re-review the inclusion/exclusion criteria to ensure that the participants meets criteria for the study. All participants will undergo vital signs and an ECG to ensure minimal cardiovascular risk prior to receiving rivastigmine. Appropriate lab work will also be performed to exclude other potential causes of cognitive impairment.

At baseline visits, participants will undergo a short neurological exam, an MRI scan, attention testing, and a detailed behavioral assessment, after which they 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. At this visit a short neurological exam will also be conducted. After 12 weeks, participants will again undergo a short neurological exam, an fMRI scan, attention testing and a behavioral assessment. Adverse events and compliance will be assessed every 2 weeks of the study.

Informants will be asked to complete questionnaires regarding the primary participant at the baseline and 12 week visits.

Study Design

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

Conditions

Parkinsons Disease With Dementia

Intervention

Rivastigmine Patch 9.5 cm2

Location

UCalifornia SF
San Francisco
California
United States
94117

Status

Recruiting

Source

University of California, San Francisco

Results (where available)

View Results

Links

Clinical Trials [429 Associated Clinical Trials listed on BioPortfolio]

Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type

This study will assess the efficacy of a higher dose of rivastigmine patch (15 cm2) compared to a lower dose of the rivastigmine patch (5 cm2), in patients with severe dementia of the Alzh...

Long-Term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-Severe Dementia Associated With Parkinson's Disease (PDD)

The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underl...

Convenience, Tolerability, and Safety of Change in the Administration of Rivastigmine From Capsules to a Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

This study will use two doses of rivastigmine transdermal patch (5cm2, 10cm2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without ...

Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline

The purpose of this study is to support the optimal use of rivastigmine patch in long-term treatment of AD in patients demonstrating cognitive decline at the target maintenance dose of riv...

Exelon Patch and Combination With Memantine Comparative Trial

The primary objective is to compare the tolerability between rivastigmine patch monotherapy and combination therapy with memantine in patients with Alzheimer's disease (AD). The secondary ...

PubMed Articles [15524 Associated PubMed Articles listed on BioPortfolio]

Long-term Safety of Rivastigmine in Parkinson Disease Dementia: An Open-Label, Randomized Study.

This study investigated the long-term safety of rivastigmine (12 mg/d capsules, 9.5 mg/24 h patch) and effects on motor symptoms in patients with mild-to-moderately severe Parkinson disease dementia.

Alpha rhythm oscillations and MMSE scores are differently modified by transdermal or oral rivastigmine in patients with Alzheimer's disease.

Alzheimer's disease (AD) is the most common cause of dementia in older patients. Rivastigmine, a reversible cholinesterase inhibitor, has been shown to improve the clinical manifestations of AD by del...

Apathy and Dementia. Nosology, Assessment and Management.

Apathy, characterized by lack of motivation and loss of initiative, is a non-cognitive symptom that affects a high proportion, but not all, of patients with all forms of dementia. To explore the pheno...

Cognitive Function in Early Clinical Phase Huntington Disease after Rivastigmine Treatment.

In Huntington disease (HD) patients receiving rivastigmine treatment improvement of behavioral symptoms and of cognitive function (assessed with screening diagnostic instruments) has been reported. Th...

The Impact of Dementia Development Concurrent with Parkinson's Disease: A New Perspective.

Dementia is the leading cause of disability worldwide among chronic disease in the elderly and is a major contributor to mortality. Importantly, dementia that develops as a comorbid condition signific...

Medical and Biotech [MESH] Definitions

An electrophysiologic technique for studying cells, cell membranes, and occasionally isolated organelles. All patch-clamp methods rely on a very high-resistance seal between a micropipette and a membrane; the seal is usually attained by gentle suction. The four most common variants include on-cell patch, inside-out patch, outside-out patch, and whole-cell clamp. Patch-clamp methods are commonly used to voltage clamp, that is control the voltage across the membrane and measure current flow, but current-clamp methods, in which the current is controlled and the voltage is measured, are also used.

A medicated adhesive patch placed on the skin to deliver a specific dose of medication into the bloodstream.

Skin tests in which the sensitizer is applied to a patch of cotton cloth or gauze held in place for approximately 48-72 hours. It is used for the elicitation of a contact hypersensitivity reaction.

A familial disorder inherited as an autosomal dominant trait and characterized by the onset of progressive CHOREA and DEMENTIA in the fourth or fifth decade of life. Common initial manifestations include paranoia; poor impulse control; DEPRESSION; HALLUCINATIONS; and DELUSIONS. Eventually intellectual impairment; loss of fine motor control; ATHETOSIS; and diffuse chorea involving axial and limb musculature develops, leading to a vegetative state within 10-15 years of disease onset. The juvenile variant has a more fulminant course including SEIZURES; ATAXIA; dementia; and chorea. (From Adams et al., Principles of Neurology, 6th ed, pp1060-4)

Heterogeneous group of neurodegenerative disorders characterized by frontal and temporal lobe atrophy associated with neuronal loss, gliosis, and dementia. Patients exhibit progressive changes in social, behavioral, and/or language function. Multiple subtypes or forms are recognized based on presence or absence of TAU PROTEIN inclusions. FTLD includes three clinical syndromes: FRONTOTEMPORAL DEMENTIA, semantic dementia, and PRIMARY PROGRESSIVE NONFLUENT APHASIA.

More From BioPortfolio on "The Effects of the Rivastigmine Patch on Parkinson's Disease With Dementia (PDD)"

Search BioPortfolio:
Loading
Advertisement

Relevant Topic

Alzheimer's Disease
Latest News Clinical Trials Research Drugs Reports Corporate
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Advertisement