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Mild Cognitive Impairment in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT01519271
Recruitment Status : Completed
First Posted : January 26, 2012
Results First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Parkinson's Disease
Mild Cognitive Impairment
Interventions Drug: Exelon Patch (rivastigmine transdermal system)
Drug: Placebo Patches
Enrollment 28
Recruitment Details Potential participants were a convenience sample of PD patients primarily from the Parkinson’s Disease and Movement Disorders Center at the University of Pennsylvania. Patients between the ages of 40 and 85 y with idiopathic PD for more than 2 years and reporting cognitive were screened for study participation.
Pre-assignment Details 48 participants assessed for eligibility, 28 randomized (17 did not meet inclusion/exclusion criteria and 3 refused to participate after screening)
Arm/Group Title Placebo First Then Rivastigmine Rivastigmine First Then Placebo
Hide Arm/Group Description

Placebo patches placed on skin daily in Phase 1 and Rivastigmine 5-10cm2 patches in Phase 2. Each phase lasted for 10 weeks.

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).

5-10cm2 rivastigmine patch daily first in phase 1 and placebo patch daily in phase 2. Each phase lasted for 10 weeks.

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).

Period Title: Phase 1
Started 14 14
Completed 14 13 [1]
Not Completed 0 1
[1]
1 participant discontinued participation in the middle of phase 1.
Period Title: Phase 2
Started 12 [1] 14
Completed 12 14
Not Completed 0 0
[1]
2 participants discontinued after Phase 1
Arm/Group Title Placebo Patch First Then 5-10cm2 Rivastigmine Patch 5-10cm2 Rivastigmine Patch First First Then Placebo Patch Total
Hide Arm/Group Description

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

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 )

Each phase lasted 10 weeks.

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).

Each phase lasted 10 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
66.1  (5.5) 62.6  (10.1) 64.3  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
2
  14.3%
4
  28.6%
6
  21.4%
Male
12
  85.7%
10
  71.4%
22
  78.6%
1.Primary Outcome
Title Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)
Hide Description

The ADCS-CGIC is the most commonly used measure of global change in dementia psychopharmacology studies. This assessment is a measure of change, thus it is not appropriate for baseline administration and only administered at the end of phase visit.

The scale rates total improvement on a 7 point scale:

  1. = Very much improved
  2. = Much improved
  3. = Minimally improved
  4. = No change
  5. = Minimally worse
  6. = Much worse
  7. = Very much worse

A participant scoring a 1 or 2 is considered a responder on the CGI scale.

Time Frame The ADCS-CGIC will be administered at the end of each study phase.
Hide Outcome Measure Data
Hide Analysis Population Description
Please note this study utilized the crossover design (i.e. participants were exposed to two phases of treatment, one with placebo and one with Exelon patch). The data are comparing differences in treatment groups. Over the course of this study 2 participants discontinued study participation.
Arm/Group Title Placebo Patch Exelon Patch (Rivastigmine Transdermal System)
Hide Arm/Group Description:
Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).

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 )

Overall Number of Participants Analyzed 26 28
Mean (Standard Deviation)
Unit of Measure: scores on the CGIC
3.92  (0.94) 3.48  (0.89)
2.Secondary Outcome
Title Montreal Cognitive Assessment (MoCA)
Hide Description The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.
Time Frame The MoCA was administered in the beginning and end of each study phase.
Hide Outcome Measure Data
Hide Analysis Population Description
Please note this study utilized the crossover design (i.e. participants were exposed to two phases of treatment, one with placebo and one with Exelon patch). The data are comparing differences in treatment groups.
Arm/Group Title Placebo Rivastigmine
Hide Arm/Group Description:
Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).

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 )

Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: Score on MoCA
Baseline 25.08  (2.7) 24.93  (2.5)
Week 16 24.73  (3.7) 25.6  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rivastigmine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Cohen's D
Estimated Value .35
Estimation Comments [Not Specified]
Time Frame Adverse events were recorded at every study visit post baseline (Phase 1: Week 4 and Week 10; Phase 2: Week 14, Week 18 and Week 24).
Adverse Event Reporting Description We used a modified version of the Treatment Emergent Symptom Scale (TESS) to assess psychiatric, cognitive, and motor adverse effects.
 
Arm/Group Title Placebo Patch Exelon Patch (Rivastigmine Transdermal System)
Hide Arm/Group Description Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).

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 )

All-Cause Mortality
Placebo Patch Exelon Patch (Rivastigmine Transdermal System)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Patch Exelon Patch (Rivastigmine Transdermal System)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Patch Exelon Patch (Rivastigmine Transdermal System)
Affected / at Risk (%) Affected / at Risk (%)
Total   9/26 (34.62%)   11/28 (39.29%) 
General disorders     
Pain *  4/26 (15.38%)  5/28 (17.86%) 
Other *  9/26 (34.62%)  11/28 (39.29%) 
Fatigue *  2/26 (7.69%)  4/28 (14.29%) 
Insomnia *  2/26 (7.69%)  4/28 (14.29%) 
Weight Loss   3/26 (11.54%)  1/28 (3.57%) 
Cognitive Impairment *  3/26 (11.54%)  0/28 (0.00%) 
Depression *  3/26 (11.54%)  0/28 (0.00%) 
Nervous system disorders     
Tremor   3/26 (11.54%)  5/28 (17.86%) 
Worse Balance   4/26 (15.38%)  4/28 (14.29%) 
Increased "off" time *  1/26 (3.85%)  3/28 (10.71%) 
Psychiatric disorders     
Visual Hallucinations *  2/26 (7.69%)  3/28 (10.71%) 
Skin and subcutaneous tissue disorders     
Rash *  2/26 (7.69%)  5/28 (17.86%) 
Vascular disorders     
Increased Blood Pressure   6/26 (23.08%)  8/28 (28.57%) 
Decreased Blood Pressure   3/26 (11.54%)  4/28 (14.29%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment

The small sample size may have limited our power to detect a treatment effect.

When the study was conducted, the maximum strength of the rivastigmine patch was 9.5 mg/24 h. Since then, a higher dose has been approved by the FDA.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniel Weintraub, MD
Organization: University of Pennsylvania
Phone: 215-349-8207
EMail: Daniel.Weintraub@UPHS.UPENN.EDU
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01519271     History of Changes
Other Study ID Numbers: 813803
First Submitted: January 10, 2012
First Posted: January 26, 2012
Results First Submitted: May 24, 2016
Results First Posted: April 7, 2017
Last Update Posted: April 7, 2017