Galantamine Executive Function in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00211588
Recruitment Status : Unknown
Verified May 2007 by Memorial Hospital of Rhode Island.
Recruitment status was:  Active, not recruiting
First Posted : September 21, 2005
Last Update Posted : May 7, 2007
Ortho-McNeil Neurologics, Inc.
Information provided by:
Memorial Hospital of Rhode Island

September 13, 2005
September 21, 2005
May 7, 2007
June 2004
Not Provided
Improvement on cognitive measures [ Time Frame: 16 weeks ]
Improvement on cognitive measures
Complete list of historical versions of study NCT00211588 on Archive Site
No worsening of PD symptoms [ Time Frame: 16 weeks ]
No worsening of PD symptoms
Not Provided
Not Provided
Galantamine Executive Function in Parkinson's Disease
Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Parkinson's Disease
Drug: galantamine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
May 2007
Not Provided

Inclusion Criteria:

  • Idiopathic Parkinson's Disease

Exclusion Criteria:

  • dementia, depression, cardiac disease, gastrointestinal disease
Sexes Eligible for Study: All
60 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Memorial Hospital of Rhode Island
Ortho-McNeil Neurologics, Inc.
Principal Investigator: Joseph H Friedman, M.D. NeuroHealth
Study Director: Janet Grace, Ph.D. Memorial Hospital of RI
Memorial Hospital of Rhode Island
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP