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

History of Changes

Purpose

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	Intervention
Parkinson's Disease	Drug: galantamine


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Galantamine Galantamine hydrobromide

U.S. FDA Resources

Further study details as provided by Memorial Hospital of Rhode Island:

Primary Outcome Measures:

Improvement on cognitive measures [ Time Frame: 16 weeks ]

Secondary Outcome Measures:

No worsening of PD symptoms [ Time Frame: 16 weeks ]


Estimated Enrollment:	90
Study Start Date:	June 2004
Estimated Study Completion Date:	May 2007

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.

Eligibility


Ages Eligible for Study:	60 Years to 85 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Idiopathic Parkinson's Disease

Exclusion Criteria:

dementia, depression, cardiac disease, gastrointestinal disease

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211588

Locations


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.

Investigators


Principal Investigator:	Joseph H Friedman, M.D.	NeuroHealth
Study Director:	Janet Grace, Ph.D.	Memorial Hospital of RI

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00211588 History of Changes
Other Study ID Numbers:	GAL-EMR-4022
Study First Received:	September 13, 2005
Last Updated:	May 4, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Hospital of Rhode Island:


cognition

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 27, 2016

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