Mild Cognitive Impairment in Parkinson's Disease

A Phase IV Randomized, Double-Blind, Placebo-Controlled, Crossover Single Site Study Of Exelon® Patch (Rivastigmine Transdermal System) For Mild Cognitive Impairment In Parkinson's Disease

Patrocinadores

Patrocinador principal: University of Pennsylvania

Fuente University of Pennsylvania
Resumen breve

Mild cognitive impairment, including difficulty with solving problems, planning, attention, or recalling information, can be a significant problem for individuals with Parkinson's disease. Even mild cognitive difficulties can lead to worse functioning, quality of life, depression, and difficulty for caregivers. Thus, ideally treatment at this stage would improve both cognitive symptoms and some of the other problems associated with these symptoms.

Despite the fact that mild cognitive impairment is a serious problem for Parkinson's disease patients little is known about how best to treat it. This study is a 24-week clinical trial to see if a Food and Drug Administration (FDA)-approved drug, the Exelon (rivastigmine) Patch, is useful in treating mild cognitive impairment in patients with Parkinson's disease. Currently, the Exelon (rivastigmine) Patch is FDA-approved for the treatment of mild to moderate dementia in Alzheimer and Parkinson's disease patients.

Descripción detallada

This study has 2 phases. Each phase will last 10 weeks and there will be a 4-week break between the 2 phases. Thus, you will be enrolled in the study for a total of 24 weeks. Over the course of the 24-week period we will schedule to see you in-person 6 times and check-in with you on the telephone 4 times, 2 times during each phase.

Phase I

Screening (may be the same day as the baseline visit) - Research personnel will determine if you are eligible to participate in this study.

Visit 1 - Baseline Visit, Start Study Medication

Phone Call 1 - Check in to see how you are feeling after starting the study medication

Visit 2 - 4 Weeks after Baseline, Increase Study Medication if tolerated

Phone Call 2 - Check in to see how you are feeling after increasing the study medication

Visit 3/ Phase I Termination Visit - 10 Weeks after Baseline (Phase I Termination Visit)

4 Week Break (no study medication)

Phase II

Visit 4/ Phase II Baseline - 14 Weeks after Baseline, Start Study Medication

Phone Call 3 - Check in to see how you are feeling after starting the study medication

Visit 5 - 18 Weeks after Baseline, Increase Study Medication

Phone Call 4 - Check in to see how you are feeling after increasing the study medication

Visit 6/Phase II and Study Termination Visit - 24 Weeks after Baseline

Visits 1, 3, 4, and 6 will last for about 2 ½ hours and visits 2 and 5 about 30 minutes. The 'check in' phone calls will last approximately 5-10 minutes.

After 24 weeks, your study participation will be over.

Estado general Completed
Fecha de inicio December 2011
Fecha de Terminación June 2014
Fecha de finalización primaria June 2014
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC) The ADCS-CGIC will be administered at the end of each study phase.
Resultado secundario
Medida Periodo de tiempo
Montreal Cognitive Assessment (MoCA) The MoCA was administered in the beginning and end of each study phase.
Inscripción 28
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Exelon Patch (rivastigmine transdermal system)

Descripción: The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia. 5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )

Etiqueta de grupo de brazo: Exelon Patch (rivastigmine transdermal system)

Tipo de intervención: Drug

Nombre de intervención: Placebo Patches

Descripción: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).

Etiqueta de grupo de brazo: Placebo Patch

Elegibilidad

Criterios:

Inclusion Criteria:

1. Participants must be experiencing symptoms of mild cognitive impairment; this will be determined by study personnel.

2. Participants must be on a sable medication regimen for 2 months prior to starting the study (necessary dose adjustments during the study are acceptable).

3. Participants are capable of giving informed consent supported by not meeting Parkinson's disease Dementia criteria; this will be determined by study personnel.

Exclusion Criteria:

1. Active suicide ideation.

2. Weighing less than 100 lbs (45 kgs).

3. History of Deep Brain Stimulation surgery.

4. Diagnosis of Dementia

5. Taking certain types of medications may be an exclusion criteria, this will be reviewed with all potential participants.

6. Females that are pregnant, planning to become pregnant, or are breastfeeding will not be included in the study. Females of childbearing potential will need to verify that they are not pregnant by a negative urine pregnancy test.

Género: All

Edad mínima: 40 Years

Edad máxima: 85 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Daniel Weintraub, MD Principal Investigator University of Pennsylvania
Ubicación
Instalaciones: University of Pennsylvania, Ralston House
Ubicacion Paises

United States

Fecha de verificación

February 2017

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Placebo Patch

Tipo: Placebo Comparator

Etiqueta: Exelon Patch (rivastigmine transdermal system)

Tipo: Active Comparator

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Crossover Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov