World Health Organization site
Skip Navigation Links

Please fill this short user satisfaction survey


Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01340885
Date of registration: 19/04/2011
Prospective Registration: No
Primary sponsor: Oregon Health and Science University
Public title: Cognitive Decline in Non-demented PD
Scientific title: Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study
Date of first enrolment: January 2011
Target sample size: 9
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01340885
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Jau-Shin Lou, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Oregon Health and Science University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of Parkinson's disease

- Respond to levodopa therapy

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Parkinson's Disease
Intervention(s)
Drug: Strattera
Other: Placebo
Drug: Exelon
Primary Outcome(s)
Attention Network Effects [Time Frame: 6 weeks]
Secondary Outcome(s)
Daytime Sleepiness [Time Frame: 6 weeks]
Depression [Time Frame: 6 weeks]
Fatigue [Time Frame: 6 weeks]
Quality of Life [Time Frame: 6 weeks]
Stroop Color Word Test [Time Frame: 6 weeks]
Secondary ID(s)
5P50NS062684-02
PANUC - Lou
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Institute of Neurological Disorders and Stroke (NINDS)
Ethics review
Results
Results available: Yes
Date Posted: 07/07/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01340885
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history Please fill this short user satisfaction survey