Mild Cognitive Impairment in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519271
• Other study ID #: 813803
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2012
• Last updated: February 24, 2015
• Start date: December 2011
• Est. completion date: June 2014

Study information

• Verified date: January 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Exelon Patch (rivastigmine transdermal system)
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 )
• Placebo Patches
The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).

Locations

Country	Name	City	State
United States	University of Pennsylvania, Ralston House	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)	The ADCS-CGIC is the most commonly used measure of global change in dementia psychopharmacology studies.	The ADCS-CGIC will be administered at baseline, week 4, week 10, week 14, week 18, and week 24.	No
Secondary	Treatment Emergent Symptom Scale (TESS)	We previously used a modified TESS to assess psychiatric, cognitive, and motor adverse effects in psychiatric treatment studies in Parkinson's Disease.	The TESS be administered at week 4, week 10, week 14, week 18, and week 24.	Yes
Secondary	Montreal Cognitive Assessment (MoCA)	The MoCA will be used as the global cognitive screening instrument.	The MoCA will be administered at baseline, week 10, week 14, and week 24.	No
Secondary	Mind Streams Global Assessment Battery (GAB)	The GAB, which includes tests of memory, executive function, visual spatial function, verbal function, attention, information processing speed, and motor skills.	The GAB will be administered at baseline, week 10, week 14, and week 24.	No
Secondary	Clinical Dementia Rating (CDR)	The CDR will be used as an assessment of cognitive function and as a means of identifying potential participants with MCI.	The CDR will be administered at baseline, week 10, week 14, and week 24.	No
Secondary	Functional Activities Questionnaire (FAQ)	The FAQ assesses Individual Activities of Daily Living (IADLs).	The FAQ will be administered at baseline, week 10, week 14, and week 24.	No
Secondary	Assessment of Daily Function Questionnaire	The Assessment of Daily Function Questionnaire is specific to cognitive impairment.	The Assessment of Daily Function Questionnaire will be administered at baseline, week 10, week 14, and week 24.	No
Secondary	Parkinson Disease Questionnaire (PDQ-8)	The 8-item version of the PDQ-39 will serve as a disease-specific measure of health-related Quality of Life.)	The PDQ-8 will be administered at baseline, week 10, week 14, and week 24.	No
Secondary	Gordon Diagnostic System (GDS)	Attentional impairment specifically is a strong predictor of the ability to perform Activities of Daily Living in Parkinson's Disease. Therefore, we will add the GDS as a specific measure of attention.	The GDS will be administered at baseline, week 10, week 14, and week 24.	No
Secondary	Dementia Rating Scale (DRS-2)	The DRS-2 has been validated as an assessment instrument for Parkinson's Disease Dementia, discriminates between Parkinson's Disease-Mild Cognitive Impairment and Parkinson's Disease Dementia, predicts long-term conversion to Parkinson's Disease Dementia, and is sensitive to improvements in cognition and Activities of Daily Living function associated with treatment.	The DRS-2 will be administered at baseline, week 10, week 14, and week 24.	No
Secondary	Psychiatric Measures	The 15-item Geriatric Depression Scale (GDS-15), State Anxiety Inventory (SAI), Apathy Scale, and a modified Parkinson's Psychosis Rating Scale (PPRS) will be used as measures of severity of psychiatric symptoms and to probe the impact of rivastigmine treatment on psychiatric symptoms that are frequently co-morbid with cognitive impairment in Parkinson's Disease.	These instruments will be administered at baseline, week 10, week 14, and week 24.	No
Secondary	Measures of Parkinson's Disease Severity	The UPDRS motor component (Part III) and the Hoehn & Yahr stage will be used as measures of disease severity. The Schwab and England will be used as a measure of Activities of Daily Living.	The UPDRS will be administered at baseline, week 10, week 14, and week 24, and the Hoehn & Yahr stage and Schwab and England Scale will be administered at baseline only	No
Secondary	Everyday Cognition Battery (ECB) and Memory Acquisition-Transfer Task	The Everyday Cognition Battery will be administered as a performance-based measure of functional abilities. Likewise, the Memory Acquisition-Transfer Task, a computer-based measure of memory acquisition and transfer will be administered if time allows.	If time allows both measures will be administered at baseline, week 10, week 14, and week 24.	No