Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5P50NS062684-02 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Cognitive dysfunction can occur in early stage of Parkinson's disease (PD) and increases as PD progresses. Attention deficits in PD patients with dementia strongly predict the impairment of their daily living activities.
Previous studies have shown that atomoxetine improves PD executive dysfunction and rivastigmine improves attention deficits in PD patients with dementia without worsening the motor symptoms.
The aim of this study is to examine the effect of atomoxetine and rivastigmine on attention and quality of life in PD patients without disabling cognitive impairment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| atomoxetine | Active Comparator | Strattera 10-30 mg b.i.d. |
|
| rivastigimine | Active Comparator | Exelon 1.5-4.5 mg b.i.d. |
|
| Placebo | Placebo Comparator | sugar pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strattera | Drug | 10-30 mg b.i.d. for 6 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Attention Network Effects | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | PDQ-39 | 6 weeks |
| Stroop Color Word Test | 6 weeks | |
| Fatigue |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jau-Shin Lou, MD, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine | Strattera 10-30 mg b.i.d. Strattera: 10-30 mg b.i.d. for 6 weeks |
| FG001 | Rivastigimine | Exelon 1.5-4.5 mg b.i.d. Exelon: 1.5-4.5 mg b.i.d. for 6 weeks |
| FG002 | Placebo | sugar pill Placebo: 2-6 pills for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine | Strattera 10-30 mg b.i.d. Strattera: 10-30 mg b.i.d. for 6 weeks |
| BG001 | Rivastigimine | Exelon 1.5-4.5 mg b.i.d. Exelon: 1.5-4.5 mg b.i.d. for 6 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Attention Network Effects | 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. | Posted | 6 weeks |
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atomoxetine | Strattera 10-30 mg b.i.d. Strattera: 10-30 mg b.i.d. for 6 weeks |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Dimitrova | Oregon Health & Science University | 503-494-7269 | dimitrov@ohsu.edu |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| D000068836 | Rivastigmine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D048448 | Phenylcarbamates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Exelon | Drug | 1.5-4.5 mg b.i.d. for 6 weeks |
|
|
| Placebo | Other | 2-6 pills for 6 weeks |
|
|
| 6 weeks |
| Depression | 6 weeks |
| Daytime Sleepiness | 6 weeks |
| BG002 | Placebo | sugar pill Placebo: 2-6 pills for 6 weeks |
| BG003 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
sugar pill
Placebo: 2-6 pills for 6 weeks
|
| Secondary | Quality of Life | PDQ-39 | 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. | Posted | 6 weeks |
|
|
| Secondary | Stroop Color Word Test | 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. | Posted | 6 weeks |
|
|
| Secondary | Fatigue | 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. | Posted | 6 weeks |
|
|
| Secondary | Depression | 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. | Posted | 6 weeks |
|
|
| Secondary | Daytime Sleepiness | 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. | Posted | 6 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Rivastigimine | Exelon 1.5-4.5 mg b.i.d. Exelon: 1.5-4.5 mg b.i.d. for 6 weeks | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Placebo | sugar pill Placebo: 2-6 pills for 6 weeks | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002219 |
| Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D002241 | Carbohydrates |