Efficacy and safety of delta-9-tetrahydrocannabinol (delta-THC) in behavioural disturbances and pain in dementia - delta-THC in dementia

Radboud university medical center0 个研究点目标入组 150 人开始时间: 2012年3月13日最近更新: 2022年5月30日

适应症

试验速览

暂无简介。

•- 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.
•- Informed consent by the subject and subject’s informal caregiver.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•- 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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