Parkinson's Disease
Conditions
Keywords
attention, mild cognitive impairment, dementia
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).
Detailed description
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.
Interventions
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Attention Network Effects | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daytime Sleepiness | 6 weeks | — |
| Quality of Life | 6 weeks | PDQ-39 |
| Stroop Color Word Test | 6 weeks | — |
| Fatigue | 6 weeks | — |
| Depression | 6 weeks | — |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Atomoxetine Strattera 10-30 mg b.i.d.
Strattera: 10-30 mg b.i.d. for 6 weeks | 0 |
| Rivastigimine Exelon 1.5-4.5 mg b.i.d.
Exelon: 1.5-4.5 mg b.i.d. for 6 weeks | 0 |
| Placebo sugar pill
Placebo: 2-6 pills for 6 weeks | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Attention Network Effects
Time frame: 6 weeks
Population: 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.
Secondary
Daytime Sleepiness
Time frame: 6 weeks
Population: 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.
Secondary
Depression
Time frame: 6 weeks
Population: 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.
Secondary
Fatigue
Time frame: 6 weeks
Population: 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.
Secondary
Quality of Life
PDQ-39
Time frame: 6 weeks
Population: 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.
Secondary
Stroop Color Word Test
Time frame: 6 weeks
Population: 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.