NCT00211588

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

May 7, 2007

Status Verified

May 1, 2007

First QC Date

September 13, 2005

Last Update Submit

May 4, 2007

Conditions

Parkinson's Disease

Keywords

cognition

Outcome Measures

Primary Outcomes (1)

  • Improvement on cognitive measures

    16 weeks

Secondary Outcomes (1)

  • No worsening of PD symptoms

    16 weeks

Interventions

galantamineDRUG

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkinson's Disease

You may not qualify if:

  • dementia, depression, cardiac disease, gastrointestinal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hospital of RI

Pawtucket, Rhode Island, 02860, United States

Location

Related Publications (1)

  • 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.

    PMID: 26040709DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Amaryllidaceae AlkaloidsAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Joseph H Friedman, M.D.

    NeuroHealth

    PRINCIPAL INVESTIGATOR

  • Janet Grace, Ph.D.

    Memorial Hospital of RI

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 2004

Study Completion

May 1, 2007

Last Updated

May 7, 2007

Record last verified: 2007-05

Locations

US(1)