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Galantamine Executive Function in Parkinson's Disease

NCT ID: NCT00211588

Last Updated: 2007-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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galantamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Idiopathic Parkinson's Disease

Exclusion Criteria

* dementia, depression, cardiac disease, gastrointestinal disease
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ortho-McNeil Neurologics, Inc.

INDUSTRY

Sponsor Role collaborator

Memorial Hospital of Rhode Island

OTHER

Sponsor Role lead

Principal Investigators

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Joseph H Friedman, M.D.

Role: PRINCIPAL_INVESTIGATOR

NeuroHealth

Janet Grace, Ph.D.

Role: STUDY_DIRECTOR

Memorial Hospital of RI

Locations

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Memorial Hospital of RI

Pawtucket, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26040709 (View on PubMed)

Other Identifiers

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GAL-EMR-4022

Identifier Type: -

Identifier Source: org_study_id