Galantamine Executive Function in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
galantamine
Sponsored by
About this trial
This is an interventional prevention trial for Parkinson's Disease focused on measuring cognition
Eligibility Criteria
Inclusion Criteria: Idiopathic Parkinson's Disease Exclusion Criteria: dementia, depression, cardiac disease, gastrointestinal disease
Sites / Locations
- Memorial Hospital of RI
Outcomes
Primary Outcome Measures
Improvement on cognitive measures
Secondary Outcome Measures
No worsening of PD symptoms
Full Information
NCT ID
NCT00211588
First Posted
September 13, 2005
Last Updated
May 4, 2007
Sponsor
Memorial Hospital of Rhode Island
Collaborators
Ortho-McNeil Neurologics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00211588
Brief Title
Galantamine Executive Function in Parkinson's Disease
Official Title
Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Memorial Hospital of Rhode Island
Collaborators
Ortho-McNeil Neurologics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to determine whether galantamine stabilizes or improves thinking abilities in individuals with Parkinson's disease. Individuals included in the study have minor complaints about thinking such as problems with concentration or memory but do not have dementia. This medication has been shown to have a positive effect on stabilizing memory in individuals with Alzheimer's disease. It is FDA approved for use in elderly individuals with Alzheimer's disease. It is hypothesized that galantamine will stabilize or improve executive and attentional functions in individuals with Parkinson's.
Detailed Description
While several cholinesterase inhibitors have effectiveness in Alzheimer's disease (AD), galantamine is unique since it has a dual mode of action: inhibition of acetylcholinesterase and modulation of nicotinic acetylcholine receptors.As Parkinson's disease (PD) impacts frontal systems, executive cognition rather than memory function (mediated by medial temporal) would be the targeted area for potential improvement. This single center, double blind, placebo controlled study compares a group of PD patients treated with galantamine to a group of PD patients who are not treated with this medication on a series of cognitive tasks that examine attention and executive control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
cognition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
galantamine
Primary Outcome Measure Information:
Title
Improvement on cognitive measures
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
No worsening of PD symptoms
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Idiopathic Parkinson's Disease
Exclusion Criteria:
dementia, depression, cardiac disease, gastrointestinal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph H Friedman, M.D.
Organizational Affiliation
NeuroHealth
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janet Grace, Ph.D.
Organizational Affiliation
Memorial Hospital of RI
Official's Role
Study Director
Facility Information:
Facility Name
Memorial Hospital of RI
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26040709
Citation
Buelow MT, Amick MM, Queller S, Stout JC, Friedman JH, Grace J. Feasibility of use of probabilistic reversal learning and serial reaction time tasks in clinical trials of Parkinson's disease. Parkinsonism Relat Disord. 2015 Aug;21(8):894-8. doi: 10.1016/j.parkreldis.2015.05.019. Epub 2015 May 27.
Results Reference
derived
Learn more about this trial
Galantamine Executive Function in Parkinson's Disease
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