Cannabidiol: Treatment for brain changes and depression in early-stage dementia

niversity of Wollongong0 个研究点目标入组 1 人开始时间: 2021年10月8日最近更新: 2023年9月26日

适应症

试验速览

暂无简介。

•1.Community-dwelling individuals who can provide written informed consent, with a clinician confirmed primary diagnosis of early dementia made within the past 24 months. Participants must have a nominated supporting person, preferably living with them (e.g. spouse) who can assist with daily medication monitoring.
•2.A Stage 3-5 rating on the Global Deterioration Scale (GDS)
•3.A score of 20-26 on the Mini Mental State Exam (MMSE);
•4.If taking general medications (e.g. Micardis, Advil), participants must have been taking them for a minimum of 6-12 weeks prior to the start of the trial, with no changes to medication regime during the 12-week trial period unless clinician-recommended changes are required for appropriate care.

•Participants will be excluded on the basis of:
•1.MRI contraindications, such as severe head injury, pace devices, coronary or peripheral artery stents, cochlear implants, renal insufficiency or claustrophobia;
•2.Allergies to the excipient used in the formulation of the capsules;
•3.Impaired liver or kidney or heart function;
•4.Active suicidal ideation;
•5.Intake of CBD, THC or cannabis within one month prior to participation;
•6.Prior extensive use of CBD, defined as use greater than weekly for more than 3 months in the two years prior to participation;
•7.A clinically relevant history of recreational cannabis use or other drugs of abuse, defined as more than three times a week for any continuous period of longer than 6 months in duration in the year prior to participation;
•8.Prior history of treatment for alcohol use disorder in the year prior to participation, or a current score of 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT);
•9.Any current or recent diagnoses of neurological disorders other than dementia, including epilepsy or Parkinson’s disease;
•10.Current use of medications that have clinically relevant interactions with the cytochrome P450 (CYP) 2C19 or CYP3A classes of liver enzymes prior to study inclusion (e.g. antipsychotics, antidepressants, anxiolytics);
•11.Participation in any other clinical drug trials within 30 days of the current study;
•12.Anticipated surgical needs within 3 months of participation.

发起方

niversity of Wollongong