Cognitive Decline in Non-demented PD
Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study
2 other identifiers
interventional
9
1 country
1
Brief Summary
The purpose of this study is to determine the relationship between attention and quality of life and how rivastigmine and atomoxetine alter attention in non-demented persons with Parkinson's disease (PD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2011
1 active site
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
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 19, 2011
CompletedFirst Posted
Study publicly available on registry
April 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
July 7, 2020
CompletedJuly 7, 2020
June 1, 2020
2 years
April 19, 2011
June 17, 2020
June 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Attention Network Effects
6 weeks
Secondary Outcomes (5)
Quality of Life
6 weeks
Stroop Color Word Test
6 weeks
Fatigue
6 weeks
Depression
6 weeks
Daytime Sleepiness
6 weeks
Study Arms (3)
atomoxetine
ACTIVE COMPARATORStrattera 10-30 mg b.i.d.
rivastigimine
ACTIVE COMPARATORExelon 1.5-4.5 mg b.i.d.
Placebo
PLACEBO COMPARATORsugar pill
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Parkinson's disease
- Respond to levodopa therapy
You may not qualify if:
- Dementia
- Psychiatric disorders including anxiety disorders, dissociative disorders, mood disorders, schizophrenia and related disorders, or ADD/ADHD
- Any clinically unstable disease such as cancer, HIV/AIDS, heart condition, liver disease, kidney or renal failure or others that might require hospitalization
- Evidence for another neurological disease (history of seizures, Alzheimer disease, multiple sclerosis or other movement disorders);
- Currently using any of the study drugs;
- Colorblindness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study did not enroll enough subjects to reach meaningful results at the time of original conduct. While study data are/were retained per investigator responsibility, sincere attempts to access these data for retrospective analysis were unsuccessful.
Results Point of Contact
- Title
- Diana Dimitrova
- Organization
- Oregon Health & Science University
Study Officials
- PRINCIPAL INVESTIGATOR
Jau-Shin Lou, MD, PhD
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 19, 2011
First Posted
April 25, 2011
Study Start
January 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
July 7, 2020
Results First Posted
July 7, 2020
Record last verified: 2020-06