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This study involves Parkinson's disease (PD). Symptoms include slow movement, tremor, and muscle rigidity. Current medications for the treatment of PD do not improve gait and balance difficulties in individuals with PD. Donepezil (study drug) has been found to reduce falls in individuals with PD. The mechanism in which this reduction of falls occurs is unclear. The investigators study will look at what aspects of gait and balance are improved by the study drug. The study drug is not approved to treat PD in the United States or other countries because we do not know enough about it.
Parkinson's disease (PD) is a common neuro-degenerative disease affecting about 2% of the adult population in the United States over the age of 65. Some of the most disabling symptoms of Parkinson's disease are balance and gait dysfunction, leading to falls. These symptoms do not respond to current dopamine directed therapies. Evidence from both pathologic studies and advanced imaging has demonstrated that a cholinergic deficiency in the thalamus and basal ganglia is found in individuals with PD who fall compared to non-fallers. The central acting acetylcholine esterase inhibitor, donepezil, has been demonstrated to decrease falls in individuals with PD. The mechanism by which falls decreased is unknown. Our open label pilot data indicates that donepezil can improve quantitative measures of balance in individuals with PD. Suggesting that improvements in balance in the mechanism by which donepezil reduces falls. Our goal is to determine whether donepezil will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donepezil, Then Placebo | Experimental | Donepezil 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6. After a washout period of 4 weeks, placebo 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6. |
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| Placebo, Then Donepezil | Experimental | Placebo 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6. After a washout period of 4 weeks, donepezil 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil | Drug | Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensory Organization Test - Composite Score | Balance was measured using the Sensory Organization test (SOT) on the NeuroCom Balance Master Clinical Research System platform (Neurocom International, Inc), which tests sway in 6 conditions, eyes open, eyes closed, and a moving visual surround first with a stable platform then with a moving platform. Center of Pressure (CoP) was calculated from the recordings. Forces and moments were recorded at 100Hz sampling frequency. A change score from the beginning of each treatment phase (placebo or active drug) to the end of the treatment phase. The SOT is scored on an interval scale with the highest possible score of 100 indicating no sway at all. The lowest possible score of 0 indicates the trial was stopped due to an impending fall. Higher scores are indicative of better balance (greater stability). | Change from Day 1 of each treatment phase to Day 42 of each treatment phase |
| Sensory Organization Test (SOT) - Condition 4 (Eyes Open, Moving Surround, Stable Platform). | Condition 4 of the Sensory Organization Test. The participants eyes are open as the surround moves and the platform remains stable. A change score from the beginning of each treatment phase (placebo or active drug) to the end of the treatment phase. The SOT is scored on an interval scale with the highest possible score of 100 indicating no sway at all. The lowest possible score of 0 indicates the trial was stopped due to an impending fall. Higher scores are indicative of better balance (greater stability). | Change from Day 1 of each treatment phase to Day 42 of each treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Trails B - A | The Trail Making Test (TMT) consists of two parts (A & B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test provides information about visual search speed, scanning, speed of processing, and executive functioning. Part A measures processing speed and part B measures executive functioning. The TMT is time to complete each part of the test in seconds. Higher scores indicate greater impairment. Subtracting part A from part B (Trails B-A) is theorized to reduce the influence of the working memory and visuo-spatial demands and, therefore, provides a relatively pure indicator of executive function. A change score from the beginning of each treatment phase (placebo or active drug) to the end of the treatment phase. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Kareus, MD | Movement Disorders Program - Parkinson's Center of Oregon - Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkinson's Center of Oregon - Oregon Health and Science University | Portland | Oregon | 97239 | United States |
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Participants were recruited through a large university movement disorders clinic in the Northwest. Inclusion criteria were idiopathic PD, treated with levodopa for at least a year, on a stable antiparkinson regiment for at least one month, abnormal dynamic posturography. Exclusion criteria: dementia (MMSE < 27), another medical condition affecting gait, unable to stand unassisted for 30 minutes, taking a cholinesterase inhibitor or anticholinergic medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Donepezil, Then Placebo | Donepezil: Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days. After a washout of 4 weeks, Placebo: Use 1 capsule (5 mg) once per day for first 21 days 10mg qday for 21 days. |
| FG001 | Placebo, Then Donepezil | Placebo: Use 1 capsule (5 mg) once per day for first 21 days 10mg qday for 21 days. After a washout of 4 weeks, Donepezil: Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (6 Weeks) |
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| Washout (4 Weeks) |
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| Second Intervention (6 Weeks) |
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Baseline characteristics are reported on all study completers (N = 10).
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| ID | Title | Description |
|---|---|---|
| BG000 | Total | Total of all study completers. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Sensory Organization Test - Composite Score | Balance was measured using the Sensory Organization test (SOT) on the NeuroCom Balance Master Clinical Research System platform (Neurocom International, Inc), which tests sway in 6 conditions, eyes open, eyes closed, and a moving visual surround first with a stable platform then with a moving platform. Center of Pressure (CoP) was calculated from the recordings. Forces and moments were recorded at 100Hz sampling frequency. A change score from the beginning of each treatment phase (placebo or active drug) to the end of the treatment phase. The SOT is scored on an interval scale with the highest possible score of 100 indicating no sway at all. The lowest possible score of 0 indicates the trial was stopped due to an impending fall. Higher scores are indicative of better balance (greater stability). | Posted | Mean | Standard Deviation | score on a scale | Change from Day 1 of each treatment phase to Day 42 of each treatment phase |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Donepezil | Donepezil: Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days in either the first or last 6 weeks of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment | Nausea, Diarrhea, Vomiting, or gastrointestinal discomfort |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amie Hiller, MD | Oregon Health & Science University | 503 721 1091 | peterami@ohsu.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | Use 1 capsule (5 mg) once per day for first 21 days than 10mg qday for 21 days. |
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| Change from Day 1 of each treatment phase to Day 42 of each treatment phase |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Unified Parkinson's Disease Rating Scale - Motor Section | This is the motor subsection of the Unified Parkinson's Disease Rating Scale (UPDRS) and is a commonly used tool to rate the symptoms of Parkinson's disease. Each item on the scale is rated from 0 (normal) to 4 (Can barely perform the task) several motor areas including speech, facial expression, tremor, rigidity, hand movements, agility, posture, and gait. Total score ranges from 0 to 108 with higher values on this scale represent a more severe stage of the disease. | Mean | Standard Deviation | units on a scale |
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| Parkinson's Disease Duration (years) | Number of years since self-reported diagnosis (Diagnosis Year - Screening Visit Year). | Mean | Standard Deviation | years |
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| Mini-Mental Status Exam (MMSE) | The Mini-Mental Status Exam (MMSE) is a widely used test of cognition the elderly. It includes tests of orientation to time and place, attention, memory, language, recall, complex commands, and visuo-spatial skills. Each item is score 0 (cannot do) to 1 (can do). All items are summed to a total score (Range 0 - 30). Those with scores 25-30 are not impaired, scores 20-25 are mildly impaired and may require some supervisions, scores 10-20 are moderately impaired, and below 10 are severely impaired and are likely to require 24-hour supervision and assistance with activities of daily living. | Mean | Standard Deviation | units on a scale |
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| Trials B-A | The Trail Making Test (TMT) consists of two parts (A & B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test provides information about visual search speed, scanning, speed of processing, and executive functioning. Part A measures processing speed and part B measures executive functioning. The TMT is time to complete each part of the test in seconds. Higher scores indicate greater impairment. Subtracting A from B (Trails B-A) is theorized to provide a relatively pure indicator of executive function. | Mean | Standard Deviation | seconds |
|
Donepezil: Use 1 capsule (5 mg) of donepezil once per day for 21 days
| OG001 | Placebo | Placebo: Use 1 capsule (5 mg) once per day for 21 days |
|
|
| Primary | Sensory Organization Test (SOT) - Condition 4 (Eyes Open, Moving Surround, Stable Platform). | Condition 4 of the Sensory Organization Test. The participants eyes are open as the surround moves and the platform remains stable. A change score from the beginning of each treatment phase (placebo or active drug) to the end of the treatment phase. The SOT is scored on an interval scale with the highest possible score of 100 indicating no sway at all. The lowest possible score of 0 indicates the trial was stopped due to an impending fall. Higher scores are indicative of better balance (greater stability). | Posted | Mean | Standard Error | units on a scale | Change from Day 1 of each treatment phase to Day 42 of each treatment phase |
|
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|
| Secondary | Trails B - A | The Trail Making Test (TMT) consists of two parts (A & B) in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. The test provides information about visual search speed, scanning, speed of processing, and executive functioning. Part A measures processing speed and part B measures executive functioning. The TMT is time to complete each part of the test in seconds. Higher scores indicate greater impairment. Subtracting part A from part B (Trails B-A) is theorized to reduce the influence of the working memory and visuo-spatial demands and, therefore, provides a relatively pure indicator of executive function. A change score from the beginning of each treatment phase (placebo or active drug) to the end of the treatment phase. | Posted | Mean | Standard Deviation | seconds | Change from Day 1 of each treatment phase to Day 42 of each treatment phase |
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| 0 |
| 18 |
| 0 |
| 18 |
| 6 |
| 18 |
| EG001 | Placebo | Placebo: Use 1 capsule (5 mg) once per day for first 21 days 10mg qday for 21 days in either the first or last 6 weeks of the study. | 0 | 16 | 0 | 16 | 1 | 16 |
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| Worsening Parkinsonism | Nervous system disorders | Non-systematic Assessment | Worsening freezing and balance |
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| Possible Transient ischemic attacks | Nervous system disorders | Non-systematic Assessment |
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| Fall | General disorders | Non-systematic Assessment | leading to hospitalization |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |