This trial is active, not recruiting.

Condition parkinson's disease
Treatment galantamine
Sponsor Memorial Hospital of Rhode Island
Collaborator Ortho-McNeil Neurologics, Inc.
Start date June 2004
End date May 2007
Trial size 90 participants
Trial identifier NCT00211588, GAL-EMR-4022


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

Improvement on cognitive measures
time frame: 16 weeks

Secondary Outcomes

No worsening of PD symptoms
time frame: 16 weeks

Eligibility Criteria

Male or female participants from 60 years up to 85 years old.

Inclusion Criteria: - Idiopathic Parkinson's Disease Exclusion Criteria: - dementia, depression, cardiac disease, gastrointestinal disease

Additional Information

Official title Investigator Initiated Study: Galantamine CR Potential Enhancement of Attentional and Executive Function in Non-Demented Patients With Parkinson's Disease
Principal investigator Joseph H Friedman, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2007.
Information provided to ClinicalTrials.gov by Memorial Hospital of Rhode Island.