Delaying the Progression of Driving Impairment in Individuals With Mild Alzheimer's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
The purpose of the study is to determine whether memantine delays the progression of driving impairment in patients with mild Alzheimer's Disease (AD).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ages 60 years of age and older
- •Subjects must either be previously diagnosed with mild Alzheimer's Disease (AD) by a neurologist, psychiatrist, geriatrician, or be evaluated at a Memory Disorders Center prior to entry into the study
- •Subjects must have a score of ≥ 23 on the Mini-Mental State Examination (MMSE) at the Screening Visit
- •Subjects must receive a passing score on the DriveABLE test
- •Female subjects must be at least 2 years post-menopausal or surgically sterile
- •Written informed consent must be obtained from the subject prior to the initiation of any study specific procedures
排除标准
- •Subjects who have been treated with a depot neuroleptic within six (6) months of the Screening Visit
- •Subjects who fail the OPTEC vision test at the screening visit
- •Subjects who score > 7 on the Hachinski Test at the screening visit
- •Subjects with evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease (subjects with controlled hypertension, right bundle branch block [complete or partial] and pacemakers may be included in the study). Subjects with thyroid disease may also be included in the study, provided they are euthyroid on treatment. Subjects with controlled diabetes may also be included
- •Recent (< 2years) B12 or folate deficiency that was considered clinically significant
- •Subjects with evidence of other psychiatric/neurologic disorders including, but not limited to, stroke, Vascular Dementia, Lewy-Body Disease, Parkinson's Disease, seizure disorder, head injury with loss of consciousness within the past 5 years, any psychotic disorder, or bipolar disorder
- •Subjects who are taking, or have taken, amantadine, ketamine, dextromethorphan that cannot be discontinued or switched to an allowable alternative medication prior to the minimum allowable interval before Baseline
- •Subjects who have been in an investigational drug study or who have received treatment with an investigational drug within 30 days (or 5 half-lives, whichever is longer) of the Screening Visit
- •Any condition, which would make the subject, in the opinion of the investigator, unsuitable for the study
- •If subjects are taking Acetylcholinesterase inhibitors (AChEls), they must be on a stable dose for > 3 months prior to baseline. No initiation of AChEls is permitted; discontinuation and dose reduction are permitted
研究组 & 干预措施
Placebo
One tablet placebo morning and evening (BID) for 12 months
干预措施: Placebo (Drug)
Memantine
One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months.
干预措施: Memantine (Drug)
结局指标
主要结局
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).
时间窗: Baseline and 12 months
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.
次要结局
- Rey Complex Figure Test(baseline and 12 months)
- Trail Making Test - Part A(baseline and 12 months)
- Fuld Object Memory Evaluation(baseline and 12 months)
- Trail Making Test - Part B(baseline and 12 months)
- Mini Mental Status Exam(baseline and 12 months)
- Motor Free Visual Perception Test - Visual Closure Subtest(baseline and 12 months)
- Cognitive Dementia Rating Scale(baseline and 12 months)
- Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)(baseline and 12 months)
- Useful Field of View(baseline and 12 months)