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Mild Cognitive Impairment in Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01519271
First received: January 10, 2012
Last updated: February 22, 2017
Last verified: February 2017
Results First Received: May 24, 2016  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
48 participants assessed for eligibility, 28 randomized (17 did not meet inclusion/exclusion criteria and 3 refused to participate after screening)

Reporting Groups
  Description
Placebo First Then Rivastigmine

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).

Rivastigmine First Then Placebo

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).


Participant Flow for 2 periods

Period 1:   Phase 1
    Placebo First Then Rivastigmine   Rivastigmine First Then Placebo
STARTED   14   14 
COMPLETED   14   13 [1] 
NOT COMPLETED   0   1 
[1] 1 participant discontinued participation in the middle of phase 1.

Period 2:   Phase 2
    Placebo First Then Rivastigmine   Rivastigmine First Then Placebo
STARTED   12 [1]   14 
COMPLETED   12   14 
NOT COMPLETED   0   0 
[1] 2 participants discontinued after Phase 1



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Patch First Then 5-10cm2 Rivastigmine Patch

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.

5-10cm2 Rivastigmine Patch First First Then Placebo Patch

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 Total of all reporting groups

Baseline Measures
   Placebo Patch First Then 5-10cm2 Rivastigmine Patch   5-10cm2 Rivastigmine Patch First First Then Placebo Patch   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   14   28 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.1  (5.5)   62.6  (10.1)   64.3  (8.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  14.3%      4  28.6%      6  21.4% 
Male      12  85.7%      10  71.4%      22  78.6% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)   [ Time Frame: The ADCS-CGIC will be administered at the end of each study phase. ]

2.  Secondary:   Montreal Cognitive Assessment (MoCA)   [ Time Frame: The MoCA was administered in the beginning and end of each study phase. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information
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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:  
Name/Title: Daniel Weintraub, MD
Organization: University of Pennsylvania
phone: 215-349-8207
e-mail: Daniel.Weintraub@UPHS.UPENN.EDU



Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01519271     History of Changes
Other Study ID Numbers: 813803
Study First Received: January 10, 2012
Results First Received: May 24, 2016
Last Updated: February 22, 2017