Galantamine Executive Function in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00211588
• Other study ID #: GAL-EMR-4022
• Status: Active, not recruiting
• Phase: N/A
• First received: September 13, 2005
• Last updated: May 4, 2007
• Start date: June 2004
• Est. completion date: May 2007

Study information

• Verified date: May 2007
• Source: Memorial Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• Idiopathic Parkinson's Disease

Exclusion Criteria:

• dementia, depression, cardiac disease, gastrointestinal disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• galantamine

Locations

Country	Name	City	State
United States	Memorial Hospital of RI	Pawtucket	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Hospital of Rhode Island	Ortho-McNeil Neurologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement on cognitive measures		16 weeks
Secondary	No worsening of PD symptoms		16 weeks