NCT03774459已完成2 期
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Patients With Parkinson's Disease With Dementia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 25
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Patients with Parkinson's Disease with Dementia (PDD)
详细描述
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, three-arm, 14-week study in PD patients with dementia. The study includes a 2 week Screening / Baseline Observation Period and a 14-week Treatment Period (including a 2 week Titration Period), and a 2-week Safety Follow-Up Period
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease (PD) consistent with the UK Parkinson's Disease Society Brain Bank diagnostic criteria.
- •Diagnosis of probable PD dementia (PDD) according to the Movement Disorder Society Task Force clinical diagnostic criteria.
- •Montreal Cognitive Assessment (MoCA) score of 13 to 23, inclusive, at Screening.
- •Male or female and aged ≥ 50 years.
- •Caregivers and subjects (or legal representative) must understand and have signed approved informed consent.
- •Caregivers and subjects (or legal representative) must be able to understand study requirements and be willing to follow instructions.
- •Stable regimen of anti-Parkinson's disease medications (including levodopa, dopamine agonists, MAO-B inhibitors, or the COMT inhibitor entacapone), which has been stable for at least 4 weeks prior to Baseline.
- •Treatment with cholinesterase inhibitor (rivastigmine, donepezil and galantamine (Exelon®, Aricept®, or Reminyl®) will be permitted, provided the dose has been stable for a minimum of 8 weeks prior to randomization.
- •Subjects with history of depression on antidepressant medications will be allowed if depression is controlled and they have been on a stable daily dose of the antidepressant for ≥8 weeks before Baseline.
- •Contraception:
- •Women of childbearing potential must use an acceptable method of contraception starting 4 weeks prior to study drug administration and for a minimum of 4 weeks after study completion. Otherwise, women must be postmenopausal (at least one year absence of vaginal bleeding or spotting) as confirmed by FSH greater than or equal to 40 mIU/mL or 40 IU/L or be surgically sterile.
- •Men with a potentially fertile partner must have had a vasectomy or be willing to use an acceptable method of contraception for the duration of the study and for 3 months after study drug discontinuation.
排除标准
- •History of any significant neurologic or psychiatric disorder other than PD that can contribute to cognitive impairment.
- •Any other condition or clinically significant abnormal findings like severe co-morbidities e.g. history of stroke, poor kidney or liver function on the physical or neurological examination, medical and psychiatric history, at screening or at baseline that, in the opinion of the Investigator, would make the subject unsuitable for the study.
- •Potential symptomatic causes of cognitive impairment including but not limited to
- •abnormal thyroid function test at screening (TSH)
- •abnormal B12 level at screening
- •MRI findings (by history) pointing to a potential symptomatic cause of cognitive dysfunction, including significant vascular changes, or communicating hydrocephalus.
- •Treatment with memantine or amantadine. If appropriate the drugs can be discontinued for a minimum of 4 weeks prior to randomization.
- •Use of over the counter (OTC) or prescription medication for sleep on 2 or more occasions per week (less than that is allowed).
- •History of depression as measured by Beck Depression Inventory score >17 at screening.
- •Treatment with any other investigational drug or device within 4 weeks prior to screening.
- •Smoking > 1 pack of cigarettes per day (as assessed for the 4 weeks prior to screening).
- •Women who are pregnant or lactating.
- •Known allergy or sensitivity to ANAVEX2-73 or any of its components.
- •Suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) of type 4 or type 5, or any suicidal behavior, in the past 6 months. Type 4 indicates active suicidal ideation with some intent to act, without a specific plan. Type 5 indicates active suicidal ideation with a specific plan and intent.
- •Use of centrally acting anticholinergic drugs during the 4 weeks before randomization.
- •Medications used for overactive bladder will be allowed provided that the regimen has been stable 4 weeks prior to randomization.
- •Treatment with any dopamine receptor blocking medications with the exception of low dose quetiapine (≤50 mg/day). Pimavanserin (≤34 mg/day) will be allowed.
- •History of neurosurgical intervention (e.g., deep brain stimulation) for PD.
- •Unpredictable motor fluctuations that would interfere with administering cognitive assessments in the ON state.
研究组 & 干预措施
High dose ANAVEX2-73
Experimental
High dose ANAVEX2-73
干预措施: High dose ANAVEX2-73 (Drug)
Mid dose ANAVEX2-73
Experimental
Mid dose ANAVEX2-73
干预措施: Mid dose ANAVEX2-73 (Drug)
Placebo oral capsule
Placebo Comparator
Placebo oral capsule
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 14 weeks
Assess the safety and tolerability of ANAVEX2-73 compared to placebo
Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention
时间窗: 14 weeks
Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test
次要结局
- SDS-CL-25(14 weeks)
- MDS-UPDRS Part III Total Score (Motor Scores)(14 weeks)
研究者
研究点 (25)
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