Mild Cognitive Impairment in Parkinson’s Disease

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: June 2014

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Placebo Comparator: Placebo Patch
  • Active Comparator: Exelon Patch (rivastigmine transdermal system)

Outcome Measures for this Clinical Trial

Primary Measures

  • Alzheimer’s Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)
    • Time Frame: The ADCS-CGIC will be administered at baseline, week 4, week 10, week 14, week 18, and week 24.
      Safety Issue?: No

Secondary Measures

  • Treatment Emergent Symptom Scale (TESS)
    • Time Frame: The TESS be administered at week 4, week 10, week 14, week 18, and week 24.
      Safety Issue?: Yes
  • Montreal Cognitive Assessment (MoCA)
    • Time Frame: The MoCA will be administered at baseline, week 10, week 14, and week 24.
      Safety Issue?: No
  • Mind Streams Global Assessment Battery (GAB)
    • Time Frame: The GAB will be administered at baseline, week 10, week 14, and week 24.
      Safety Issue?: No
  • Clinical Dementia Rating (CDR)
    • Time Frame: The CDR will be administered at baseline, week 10, week 14, and week 24.
      Safety Issue?: No
  • Functional Activities Questionnaire (FAQ)
    • Time Frame: The FAQ will be administered at baseline, week 10, week 14, and week 24.
      Safety Issue?: No
  • Assessment of Daily Function Questionnaire
    • Time Frame: The Assessment of Daily Function Questionnaire will be administered at baseline, week 10, week 14, and week 24.
      Safety Issue?: No
  • Parkinson Disease Questionnaire (PDQ-8)
    • Time Frame: The PDQ-8 will be administered at baseline, week 10, week 14, and week 24.
      Safety Issue?: No
  • Gordon Diagnostic System (GDS)
    • Time Frame: The GDS will be administered at baseline, week 10, week 14, and week 24.
      Safety Issue?: No
  • Dementia Rating Scale (DRS-2)
    • Time Frame: The DRS-2 will be administered at baseline, week 10, week 14, and week 24.
      Safety Issue?: No
  • Psychiatric Measures
    • Time Frame: These instruments will be administered at baseline, week 10, week 14, and week 24.
      Safety Issue?: No
  • Measures of Parkinson’s Disease Severity
    • Time Frame: 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
      Safety Issue?: No
  • Everyday Cognition Battery (ECB) and Memory Acquisition-Transfer Task
    • Time Frame: If time allows both measures will be administered at baseline, week 10, week 14, and week 24.
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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 regiment 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • University of Pennsylvania
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Daniel Weintraub, MD, Principal Investigator, University of Pennsylvania
  • Overall Contact(s)
    • Eugenia Mamikonyan, MS, 215-615-3085, Eugenia.Mamikonyan@uphs.upenn.edu

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01519271