Cholinergic Neurotransmission - A Common Underlying Mechanism of Cognitive and Gait Impairment in Parkinson Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Timed-Up-and-Go (TUG) duration [s]
研究概览
简要总结
This is a single-site non-randomized open label pilot study. The investigators will use accelerometer-based instrumented gait analysis and computerized cognitive testing to study the interaction of motor and cognitive dysfunction in Parkinson disease dementia (PDD), and the effect of rivastigmine on motor and cognitive performance. All study participants will be tested for motor and cognitive performance at baseline (arm 1). A subgroup of study participants will then be treated with rivastigmine for 12 weeks (arm 2), and the effect of this treatment on gait measures and cognitive measures will be analyzed at the follow-up visit 12 weeks after the baseline visit. Specifically, we will determine which components of motor and cognitive impairment are associated with each other, and which components of the two domains respond to rivastigmine-mediated stimulation of cholinergic neurotransmission.
详细描述
This is a single-site non-randomized open label clinical trial in patients with Parkinson disease (PD) and mild to moderate cognitive deficits, designed to 1) identify associations between cognitive impairment and gait impairment, and 2) identify cognitive domains and gait measures that improve after 12 weeks of treatment with rivastigmine. Aim 1 will be addressed with a cross-sectional approach (arm 1, baseline only, all participants), and aim 2 will be addressed with a longitudinal interventional approach (arm 2, 12 week-treatment with rivastigmine, subgroup of participants).
Patients with idiopathic Parkinson disease (PD) and mild to moderate cognitive deficits amounting to PD dementia (PDD) will be enrolled. At baseline (arm 1), all participants will perform the timed-up-and-go test (TUG), wearing a light-weight sensor device strapped to the lower back with a neoprene belt. Participants will also complete a computerized cognitive test battery (NeuroTrax Mild Cognitive Impairment & Early Dementia Battery by MindStreams). A subgroup of participants (arm 2) will then be treated with transdermal rivastigmine for 12 weeks, with dose increases every 4 weeks and titration up to 13.3 mg/24h, if tolerated. The same assessment (quantitative gait testing and NeuroTrax computerized cognitive test battery) will be repeated after 12 weeks, with the participant on a stable dose of transdermal rivastigmine.
The investigators will analyze correlation of iTUG measures and cognitive measures at baseline (cross-sectional analysis). The investigators will also analyze change in iTUG measures and cognitive measures between baseline and follow-up for the subgroup of participants in arm 2 (in other words, before and after rivastigmine treatment; longitudinal analysis).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Diagnosis of idiopathic Parkinson disease.
- •Mild to moderate cognitive impairment, as determined by a MoCA score of ≤ 25 and ≥
- •Patient passes the Evaluation to Sign Consent (ESC) or a legally authorized representative (LAR) is present at the time of enrollment and signs the informed consent form on behalf of the patient.
- •Patient is enrolled (or willing to be enrolled) in the University of Maryland Parkinson Disease and Movement Disorders Center PD Research Database (HP 42195)
排除标准
- •Advanced Parkinson disease (Hoehn & Yahr stage 5), with inability to walk unassisted.
- •Other medical condition(s) that significantly interfere(s) with gait and balance (e.g., advanced arthritis).
研究组 & 干预措施
Arm 2: rivastigmine (longitudinal)
As study intervention, a subgroup of participants will then be treated with transdermal rivastigmine patch for 12 weeks, with dose increases every 4 weeks and titration up to 13.3 mg/24h, if tolerated. For the arm 2 subgroup of participants, the same assessment that was performed at baseline (quantitative gait testing and NeuroTrax computerized cognitive test battery) will be repeated after 12 weeks, with the patient on a stable dose of transdermal rivastigmine.
干预措施: Rivastigmine transdermal patch (Drug)
结局指标
主要结局
Timed-Up-and-Go (TUG) duration [s]
时间窗: Data analysis will be completed within 6 months of completing study enrollment.
Time participant needs to complete the TUG.
NeuroTrax Executive Function score
时间窗: Data analysis will be completed within 6 months of completing study enrollment.
Result of the NeuroTrax computerized cognitive test of executive function.
次要结局
未报告次要终点
研究者
F. Rainer von Coelln, MD
Assistant Professor
University of Maryland, Baltimore