NCT04075435招募中早期 1 期
Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Total of clinician impression column on anxiety domain of the NPI-C
研究概览
简要总结
This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al., or MCI
- •MMSE score of 15-30 (inclusive)
- •Clinically significant degree of anxiety, as defined by a Clinical Impression total column score of ≥4 on the Anxiety domain of the NPI-C
- •A health care proxy available to sign consent on behalf of the participant (if applicable)
- •A caregiver who spends at least 10 hours per week with the subject who is able to attend all study visits
- •Participants and their study partner must be fluent in English
- •Must be 55-90 years old (inclusive)
排除标准
- •Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes.
- •Seizure disorder
- •Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as determined by the MINI
- •Current episode of major depression, as determined by the MINI
- •Active substance abuse or dependence within the past 6 months, as determined by the MINI
- •Delirium (as measured by the CAM)
- •Current inpatient hospitalization
- •Current regular use of cannabinoid products (>1 use per month)
- •Positive urine screen for THC at the screening or baseline visit
- •Allergy to coconut
- •Participants taking strong inhibitors or inducers of CYP3A4 (e.g. fluconazole, fluoxetine, fluvoxamine, ticlopidine, St. John's Wort, etc.), CYP2C19 (ketoconazole, erythromycin, etc.), or anti-epileptic drugs
研究组 & 干预措施
All subjects
Other
This arm will include all subjects, individuals will administer a high CBD, low THC full spectrum sublingual solution twice daily on a variable dosing schedule.
干预措施: high CBD/low THC sublingual solution (Drug)
结局指标
主要结局
Total of clinician impression column on anxiety domain of the NPI-C
时间窗: Continuous, weeks 0-8
Measure of Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale
次要结局
- Week 8 MMSE total score compared to baseline MMSE total score(longitudinal: screening/baseline and week8)
- Score on the confusion assessment method(Continuous screening weeks 0-8, dichotomous)
- Total score on the Generalized Anxiety Disorder 7 scale(Continuous, week 0-8)
- Number of serious adverse events(Continuous, weeks 0-8)
- Number and severity of side effects reported(Continuous, weeks 0-8)
研究者
Staci Gruber, Ph.D.
Directory, Cognitive and Clinical Neuroimaging Core; Director, Marijuana Investigations for Neuroscientific Discovery (MIND)
Mclean Hospital
研究点 (1)
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