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
  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:


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
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

No publications provided

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
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014