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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The purpose of the study is to determine whether memantine delays the progression of driving impairment in patients with mild Alzheimer's Disease (AD).
It is well known, and of great concern to both patients and families, that individuals with Alzheimer's disease (AD) eventually become driving impaired. Drivers with dementia are estimated to be 2-8 times more likely to be involved in an automobile crash as unimpaired peers. Approximately half of individuals with mild AD have the skills needed to drive safely. Formal driver evaluation may be necessary to make this distinction. Some reviews in the literature have suggested that individuals identified as high risk, such as those with AD, be advised by their physicians to cease driving altogether. Other studies suggest that these individuals may continue to drive for up to 4 years following diagnosis. Memantine may be effective in delaying the progression of driving impairment in individuals with mild AD. If the investigators can demonstrate a significant delay in the decline in the driving ability, this could extend their driving time and therefore be of immense benefit to patients and their caregivers.
Comparison(s): Subjects treated with memantine over a period of 12 months, compared to subjects on placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | One tablet placebo morning and evening (BID) for 12 months |
|
| Memantine | Active Comparator | One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Measure is the Number of Subjects in Each Group Who Are Able to Pass the DriveABLE On-Road Test at Month 12 (Endpoint). | The DriveABLE On-Road Test utilizes a standardized road course and standardized scoring procedures designed to identify driving errors indicative of decline in competence scores. This road test takes approximately 30-45 minutes and covers a distance of approximately 9 miles. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fuld Object Memory Evaluation | Ten common objects in a bag were presented to determine whether the subject could identify objects by touch. The subject was not told that memory of this event would be tested. The subject names each object and then pulls it out of the bag to see if he is correct. After distracting the subject, by asking the patient to say words rapidly from a single category (rapid verbal retrieval), the subject is asked to recall the objects from the bag. The subject was then offered two more chances to learn and recall them (store and retrieve) by reminding the subject of omitted items after each recall, with rapid verbal retrieval preventing rehearsal before each recall opportunity. Retrieval scores were summed over the three trials with the range of possible scores being 0-30. Lower scores indicate more severe impairment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J Holland, MD | Charles E, Schmidt College of Medicine at Florida Atlantic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles E. Schmidt College of Medicine, Florida Atlantic University | Boca Raton | Florida | 33431 | United States |
Prior to randomization, subjects completed a screening visit to discuss/sign informed consent and determine study eligibility. Of the 60 subjects screened, 17 were excluded due to not passing the screening visit driving test, scoring out of the inclusion criteria range on screening visit assessments or meeting an exclusion criteria.
Recruitment dates July 2007 - September 2011 Newspaper print ads, physician referral, subject referral, press releases
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| ID | Title | Description |
|---|---|---|
| FG000 | Memantine | Memantine : Memantine (Namenda)10mg BID for 12 months |
| FG001 | Placebo | Placebo : Placebo BID for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Memantine | Memantine : Memantine (Namenda)10mg BID for 12 months |
| BG001 | Placebo | Placebo : Placebo BID for 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Primary Outcome Measure is the Number of Subjects in Each Group Who Are Able to Pass the DriveABLE On-Road Test at Month 12 (Endpoint). | The DriveABLE On-Road Test utilizes a standardized road course and standardized scoring procedures designed to identify driving errors indicative of decline in competence scores. This road test takes approximately 30-45 minutes and covers a distance of approximately 9 miles. | One subject in the placebo group could not complete the driving test at 12 months due to his vision being below the legal limit to drive. | Posted | Number | participants | Baseline and 12 months |
|
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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 | Memantine | Memantine : Memantine (Namenda)10mg BID for 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mouth Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Holland, MD | Charles E. Schmidt College of Medicine, Florida Atlantic University | 561-297-0164 | holland@fau.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | One tablet placebo morning and evening (BID) for 12 months |
|
| baseline and 12 months |
| Rey Complex Figure Test | This is a measure of visual-spatial and constructional ability as well as higher order cognitive processes including planning, organizing, and problem solving. Subjects are asked to copy a complicated drawing. 18 elements are scored from 0-2 depending on accuracy/distortion and location of the reproduction. The maximum score is 36 points. Lower scores indicate more severe impairment | baseline and 12 months |
| Trail Making Test - Part A | A simple test of visual tracking. The score is the time in seconds required to complete. Higher scores indicate lower functioning. | baseline and 12 months |
| Trail Making Test - Part B | This tests cognitive flexibility and set-shifting. It is considered to be a test of executive functioning and has been shown to correlate with on-road driving ability. The score is the time in seconds required to complete each part. Higher scores indicate decreased functioning. | baseline and 12 months |
| Mini Mental Status Exam | Scores range from 0-30 with lower scores indicating decreased functioning. | baseline and 12 months |
| Useful Field of View | The Useful Field of View is a computer-administered test that measures higher order processing skills such as divided attention and visual processing speed. Scores can be predictive of ability to perform many everyday activities, such as driving a vehicle. Speed of visual processing is measured as the examinee identifies a target, but must also localize a simultaneously presented target displayed in the periphery of the computer monitor. Scores range from 1 to 4 with 1 being no impairment, 2= mild, 3= moderate and 4=serious impairment. | baseline and 12 months |
| Motor Free Visual Perception Test - Visual Closure Subtest | This is an 11 item multiple choice test of visual perception. Scores range from 0-11. This test measures visual perception deficits separate from motor skill abilities. Higher scores indicate more severe impairment. | baseline and 12 months |
| Cognitive Dementia Rating Scale | This scale is used to stage severity of dementia. Scores are on a five-point scale in which 0 indicates no cognitive impairment, .5 = very mild dementia,1 = mild, 2 = moderate and 3= severe. | baseline and 12 months |
| Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) | The ADAS-Cog is a performance based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's disease. The cognitive subscale comprises 11 items which measure word recall (0-10), ability to follow single and multi-step commands (0-5), constructional praxis (0-5), ideational praxis (0-5), naming objects(0-5), word recognition (0-12), orientation (0-8), comprehension of spoken language (0-5), word finding difficulty(0-5) and ability to remember test instructions (0-5). 0 = no impairment with higher scores indicating more severe impairment. | baseline and 12 months |
| Physician Decision: Medication Noncompli |
|
| Withdrawal by Subject |
|
| Death |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo : Placebo BID for 12 months |
|
|
| Secondary | Fuld Object Memory Evaluation | Ten common objects in a bag were presented to determine whether the subject could identify objects by touch. The subject was not told that memory of this event would be tested. The subject names each object and then pulls it out of the bag to see if he is correct. After distracting the subject, by asking the patient to say words rapidly from a single category (rapid verbal retrieval), the subject is asked to recall the objects from the bag. The subject was then offered two more chances to learn and recall them (store and retrieve) by reminding the subject of omitted items after each recall, with rapid verbal retrieval preventing rehearsal before each recall opportunity. Retrieval scores were summed over the three trials with the range of possible scores being 0-30. Lower scores indicate more severe impairment. | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 months |
|
|
|
| Secondary | Rey Complex Figure Test | This is a measure of visual-spatial and constructional ability as well as higher order cognitive processes including planning, organizing, and problem solving. Subjects are asked to copy a complicated drawing. 18 elements are scored from 0-2 depending on accuracy/distortion and location of the reproduction. The maximum score is 36 points. Lower scores indicate more severe impairment | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 months |
|
|
|
| Secondary | Trail Making Test - Part A | A simple test of visual tracking. The score is the time in seconds required to complete. Higher scores indicate lower functioning. | Posted | Mean | Standard Deviation | seconds | baseline and 12 months |
|
|
|
| Secondary | Trail Making Test - Part B | This tests cognitive flexibility and set-shifting. It is considered to be a test of executive functioning and has been shown to correlate with on-road driving ability. The score is the time in seconds required to complete each part. Higher scores indicate decreased functioning. | Posted | Mean | Standard Deviation | seconds | baseline and 12 months |
|
|
|
| Secondary | Mini Mental Status Exam | Scores range from 0-30 with lower scores indicating decreased functioning. | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 months |
|
|
|
| Secondary | Useful Field of View | The Useful Field of View is a computer-administered test that measures higher order processing skills such as divided attention and visual processing speed. Scores can be predictive of ability to perform many everyday activities, such as driving a vehicle. Speed of visual processing is measured as the examinee identifies a target, but must also localize a simultaneously presented target displayed in the periphery of the computer monitor. Scores range from 1 to 4 with 1 being no impairment, 2= mild, 3= moderate and 4=serious impairment. | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 months |
|
|
|
| Secondary | Motor Free Visual Perception Test - Visual Closure Subtest | This is an 11 item multiple choice test of visual perception. Scores range from 0-11. This test measures visual perception deficits separate from motor skill abilities. Higher scores indicate more severe impairment. | Posted | Mean | Standard Deviation | number incorrect | baseline and 12 months |
|
|
|
| Secondary | Cognitive Dementia Rating Scale | This scale is used to stage severity of dementia. Scores are on a five-point scale in which 0 indicates no cognitive impairment, .5 = very mild dementia,1 = mild, 2 = moderate and 3= severe. | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 months |
|
|
|
| Secondary | Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) | The ADAS-Cog is a performance based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's disease. The cognitive subscale comprises 11 items which measure word recall (0-10), ability to follow single and multi-step commands (0-5), constructional praxis (0-5), ideational praxis (0-5), naming objects(0-5), word recognition (0-12), orientation (0-8), comprehension of spoken language (0-5), word finding difficulty(0-5) and ability to remember test instructions (0-5). 0 = no impairment with higher scores indicating more severe impairment. | Posted | Mean | Standard Deviation | units on a scale | baseline and 12 months |
|
|
|
| 2 |
| 22 |
| 6 |
| 22 |
| EG001 | Placebo | Placebo : Placebo BID for 12 months | 3 | 21 | 9 | 21 |
| Myocardial Infarction | Cardiac disorders |
|
| Generalized Weakness | General disorders |
|
| Stroke | Vascular disorders |
|
| Rectal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Fatigue | General disorders |
|
| Headache | Nervous system disorders |
|
| Decreased Appetite | Gastrointestinal disorders |
|
| Insomnia | Nervous system disorders |
|
| Depression | Psychiatric disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Constipation | Gastrointestinal disorders |
|
| Hypothyroidism | Endocrine disorders |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| 2) Commands - Baseline |
|
| 2) Commands - 12 Months |
|
| 3) Constructional Praxis - Baseline |
|
| 3) Constructional Praxis - 12 Months |
|
| 4) Ideational Praxis - Baseline |
|
| 4) Ideational Praxis - 12 months |
|
| 5) Naming - Baseline |
|
| 5) Naming - 12 months |
|
| 6) Orientation - Baseline |
|
| 6) Orientation - 12 Months |
|
| 7) Word Recognition - Baseline |
|
| 7) Word Recognition - 12 Months |
|
| 8) Remember Test Instructions - Baseline |
|
| 8) Remember Test Instructions - 12 Months |
|
| 9) Spoken Language - Baseline |
|
| 9) Spoken Language - 12 Months |
|
| 10) Word Finding - Baseline |
|
| 10) Word Finding - 12 Months |
|
| 11) Comprehension - Baseline |
|
| 11) Comprehension - 12 Months |
|