| المؤلفون: |
Bartschi JG; School of Psychology, Faculty of the Arts, Social Sciences and Humanities, University of Wollongong, Wollongong, Australia.; Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, Australia.; Australian Center for Cannabinoid Clinical and Research Excellence (ACRE), New Lambton Heights, Australia., Greenwood LM; Australian Center for Cannabinoid Clinical and Research Excellence (ACRE), New Lambton Heights, Australia.; Research School of Psychology, The Australian National University, Canberra, Australia., Montgomery A; Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, Australia.; School of Nursing, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, Australia., Dortants L; School of Psychology, Faculty of the Arts, Social Sciences and Humanities, University of Wollongong, Wollongong, Australia.; Australian Center for Cannabinoid Clinical and Research Excellence (ACRE), New Lambton Heights, Australia., Weston-Green K; Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, Australia.; Australian Center for Cannabinoid Clinical and Research Excellence (ACRE), New Lambton Heights, Australia.; School of Medicine and Molecular Horizons, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, Australia., Huang XF; Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, Australia.; Australian Center for Cannabinoid Clinical and Research Excellence (ACRE), New Lambton Heights, Australia.; School of Medicine and Molecular Horizons, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, Australia., Pai N; Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, Australia.; School of Medicine and Molecular Horizons, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, Australia.; Southern Hospitals Network, Illawarra-Shoalhaven Local Health District, Warrawong, Australia., Potter J; Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, Australia.; School of Medicine and Molecular Horizons, Faculty of Science, Medicine and Health, University of Wollongong, Wollongong, Australia.; Southern Hospitals Network, Illawarra-Shoalhaven Local Health District, Warrawong, Australia., Schira MM; School of Psychology, Faculty of the Arts, Social Sciences and Humanities, University of Wollongong, Wollongong, Australia., Croft R; School of Psychology, Faculty of the Arts, Social Sciences and Humanities, University of Wollongong, Wollongong, Australia.; Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, Australia., Solowij N; School of Psychology, Faculty of the Arts, Social Sciences and Humanities, University of Wollongong, Wollongong, Australia.; Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, Australia.; Australian Center for Cannabinoid Clinical and Research Excellence (ACRE), New Lambton Heights, Australia. |
| مستخلص: |
Rationale: The slowing of disease progression in dementia in the early stages of diagnosis is paramount to improving the quality of life for those diagnosed and their support networks. Accumulating evidence suggests that CBD, a constituent of Cannabis sativa , is associated with neuroprotective, neuroendocrine, and psychotherapeutic effects, suggesting that it may be beneficial to dementia treatment. However, no published human study to date has examined this possibility. This trial aims to determine whether daily treatment with CBD over a 12-week period is associated with improved neurobiological, behavioral, and psychological outcomes in individuals living with early-stage dementia. Methods: Sixty participants with early-stage dementia will be recruited for a randomized, double-blind, placebo-controlled clinical trial. Participants will be randomized into either 99.9% pure CBD or placebo treatment conditions and administered two capsules per day for 12 weeks. Participants will commence a 200 mg/day dose for 2 weeks before escalating to 300 mg/day for the remaining 10 weeks. Neuroimaging and blood-based neuroendocrine profiles will be assessed at baseline and post-treatment. Psychological and behavioral symptoms will be assessed at baseline, 6 weeks, and post-treatment. Monitoring of health and side-effects will be conducted through weekly home visits. Discussion: This study is among the first to investigate the effects of isolated CBD in improving neuroanatomical and neuroendocrine changes, alongside psychological symptoms, during the early stages of dementia diagnosis. The outcomes of this trial have the capacity to inform a potential novel and accessible treatment approach for individuals living with early-stage dementia, and in turn, improve quality of life, prognoses, and treatment outcomes. Trial Registration: This trial has been registered with the Therapeutic Goods Administration (CT-2020-CTN-03849-1v2) and the Australian and New Zealand Clinical Trials Registry (ACTRN12621001364864). |
