Galantamine Executive Function in Parkinson's Disease

• Sponsor: Memorial Hospital of Rhode Island (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00211588
• Collaborator: Ortho-McNeil Neurologics, Inc. (Industry)
• Enrollment: 90
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 2.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: galantamine	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Jun 1, 2004
• Anticipated Study Completion Date: May 1, 2007

Outcome Measures

Primary Outcome Measures

1. Improvement on cognitive measures [16 weeks]

Secondary Outcome Measures

1. No worsening of PD symptoms [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Idiopathic Parkinson's Disease

Exclusion Criteria:

• dementia, depression, cardiac disease, gastrointestinal disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00211588
• Other Study ID Numbers: GAL-EMR-4022
• First Posted: Sep 21, 2005
• Last Update Posted: May 7, 2007
• Last Verified: May 1, 2007

• Keywords provided by , ,: cognition
• Additional relevant MeSH terms: Parkinson Disease; Galantamine

Study Results

No Results Posted as of May 7, 2007