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

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: galantamine Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease
Study Start Date : June 2004
Estimated Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Improvement on cognitive measures [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. No worsening of PD symptoms [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Idiopathic Parkinson's Disease

Exclusion Criteria:

  • dementia, depression, cardiac disease, gastrointestinal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00211588

United States, Rhode Island
Memorial Hospital of RI
Pawtucket, Rhode Island, United States, 02860
Sponsors and Collaborators
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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00211588     History of Changes
Other Study ID Numbers: GAL-EMR-4022
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 7, 2007
Last Verified: May 2007

Keywords provided by Memorial Hospital of Rhode Island:

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents