ACTRN12624000747527招募中2 期
KTX-201: A Multi-centre, Phase 2a, Double-blind, Placebo-controlled, Randomised Study to Examine the Safety, Tolerability, and Efficacy of KNX100 in the Treatment of Subjects with Agitation Associated with Dementia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 90 Years（—）
- 性别
- All
入选标准
- •1. Mini-mental state examination (MMSE) score of 10 to 24 (inclusive) at the screening visit
- •2. Current diagnosis of dementia (Alzheimer’s disease, Frontotemporal dementia, Lewy body dementia, multi-infarct dementia or vascular dementia) according to the criteria of the DSM 5 TR.
- •3. Clinically significant agitation meeting the International Psychogeriatric Association Provisional Criteria for Agitation in Cognitive Impairment. Has clinically significant agitation/aggression as assessed using the NPI-12
- •4. Live at home and have a consenting caregiver/study partner
排除标准
- •1. Have medical history of distressing psychotic symptoms (delusion and/or hallucinations) that required psychiatric hospitalisation
- •2. Have a clinically significant medical condition, psychiatric or neurological disease (other than the allowable study dementias), or other brain disorders
- •3. malignancy within the past 5 years, clinically significant systemic illness, infection or other significant abnormalities as determined by the investigator
研究者
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