NL-OMON39470已完成2 期
Efficacy and safety of delta-9-tetrahydrocannabinol (delta-THC) in behavioural disturbances in dementia - delta-THC in dementia
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Subject has possible or probable dementia, type AD, VaD or AD/VaD, according to the criteria of NINCDS-ADRDA/NINCDS-AIREN or based on an expert panel decision.;- Clinical Dementia Rating (CDR) score 1 to 3 (mild to severe dementia).;- Clinically relevant behavioural disturbances existing at least one month prior to screening, defined as a score of >= 10 on the NPI, including presence of the domain agitation/aggression or motor disturbance.;- if applicable: subject agrees with temporarily stopping analgesic drugs for the duration of the study;- Informed consent by the subject and subject*s informal caregiver.
排除标准
- •- Dementia other than AD, VaD or AD/VaD;- Major psychiatric disorder ;- History of, or current drug abuse.;- Current alcohol abuse or unwillingness to use no more than 2 alcoholic consumptions daily ;- Severe (and/or unstable) concomitant or intercurrent illness;- Clinical or biochemical evidence of liver disease (ALT or AST >= twice the upper limit of normal) or known allergy to acetaminophen.;- Use of tricyclic antidepressants (TCA), carbamazepine or fluoxetine.;- Changes in dosage of antipsychotics, benzodiazepines or cholinesterase inhibitors within 2 weeks prior to intervention.
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