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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01340885 |
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Date of registration:
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19/04/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cognitive Decline in Non-demented PD
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Scientific title:
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Cognitive Dysfunction in PD: Pathophysiology and Potential Treatments, a Pilot Study |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01340885 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Jau-Shin Lou, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: Strattera
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Drug: Exelon
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Other: Placebo
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Primary Outcome(s)
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Attention Network Effects
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Daytime Sleepiness
[Time Frame: 6 weeks]
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Quality of Life
[Time Frame: 6 weeks]
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Stroop Color Word Test
[Time Frame: 6 weeks]
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Depression
[Time Frame: 6 weeks]
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Fatigue
[Time Frame: 6 weeks]
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Secondary ID(s)
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PANUC - Lou
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5P50NS062684-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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