Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Galantamine Executive Function in Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Memorial Hospital of Rhode Island.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ortho-McNeil Neurologics, Inc.
Information provided by:
Memorial Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT00211588
First received: September 13, 2005
Last updated: May 4, 2007
Last verified: May 2007

September 13, 2005
May 4, 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 ClinicalTrials.gov 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Parkinson's Disease
Drug: galantamine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
May 2007
Not Provided

Inclusion Criteria:

  • Idiopathic Parkinson's Disease

Exclusion Criteria:

  • dementia, depression, cardiac disease, gastrointestinal disease
Both
60 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00211588
GAL-EMR-4022
Yes
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