Sharon Cohen, MD, FRCPC, Medical Director and Site Principal Investigator, 1 Valleybrook Drive, Suite 400, Toronto, Canada M3B 2S7, Tel: 416-386-9761; Fax: 416-386-0458,
J Prev Alzheimers Dis. 2023;10(4):771-777. doi: 10.14283/jpad.2023.123.
Lecanemab is a humanized IgG1 monoclonal antibody binding with high affinity to amyloid-beta protein protofibrils. In phase 3 development, lecanemab has been shown to reduce markers of amyloid in early Alzheimer's disease and reduce decline on clinical endpoints of cognition and function at 18 months.
To describe the health-related quality-of-life (HRQoL) results from Clarity AD which were exploratory outcomes in this trial.
Clarity AD was an 18-month, multi-center, double-blind, phase 3 trial.
Early Alzheimer's disease.
Individuals 50-90 years of age with a diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease and positron emission tomography or cerebrospinal fluid evidence of cerebral amyloid accumulation.
Placebo or lecanemab 10-mg/kg IV biweekly.
HRQoL was measured at baseline and every 6 months using the European Quality of Life-5 Dimensions (EQ-5D-5L; by subject) and Quality of Life in AD (QOL-AD; by subject and proxy). Study partner burden was measured using the Zarit Burden Interview (ZBI).
A total of 1795 participants were enrolled (lecanemab:898; placebo:897). At month 18, adjusted mean change from baseline in EQ-5D-5L and QOL-AD by subject showed 49% and 56% less decline, respectively. QOL-AD rated by study partner as proxy resulted in 23% less decline. ZBI adjusted mean change from baseline at 18 months resulted in 38% less increase of care partner burden. Individual HRQoL test items and dimensions also showed lecanemab benefit.
Lecanemab was associated with a relative preservation of HRQoL and less increase in caregiver burden, with consistent benefits seen across different quality of life scales and within scale subdomains. These benefits provide valuable patient reported outcomes which, together with previously reported benefits of lecanemab across multiple measures of cognition, function, disease progression, and biomarkers, demonstrate that lecanemab treatment may offer meaningful benefits to patients, care partners, and society.
Lecanemab 是一种与人源 IgG1 高度亲和力结合的单克隆抗体，能与淀粉样β蛋白原纤维结合。在 3 期开发中，lecanemab 已被证明可降低早期阿尔茨海默病的淀粉样蛋白标志物，并在 18 个月时降低认知和功能临床终点的下降。
描述 Clarity AD 中的健康相关生活质量（HRQoL）结果，这是该试验的探索性结果。
Clarity AD 是一项为期 18 个月、多中心、双盲、3 期临床试验。
早期阿尔茨海默病。
年龄在 50-90 岁之间，经诊断患有轻度认知障碍或轻度阿尔茨海默病痴呆，正电子发射断层扫描或脑脊液显示大脑淀粉样蛋白堆积。
安慰剂或 lecanemab 10-mg/kg IV 每两周一次。
使用欧洲生活质量 5 维度问卷（EQ-5D-5L；由受试者）和阿尔茨海默病生活质量问卷（QOL-AD；由受试者和代理），在基线和每 6 个月测量一次 HRQoL。使用 Zarit 负担访谈量表（ZBI）测量研究伙伴负担。
共纳入 1795 名参与者（lecanemab：898；安慰剂：897）。在第 18 个月时，与基线相比，EQ-5D-5L 和 QOL-AD 的调整后平均变化分别减少了 49%和 56%。研究伙伴作为代理评定的 QOL-AD 下降了 23%。18 个月时 ZBI 的调整后平均变化导致照顾者负担增加了 38%。单个 HRQoL 测试项目和维度也显示出 lecanemab 的益处。
Lecanemab 与 HRQoL 的相对保留和照顾者负担的增加相关，在不同的生活质量量表和量表内的子领域都有一致的益处。这些益处提供了有价值的患者报告结果，与之前报道的 lecanemab 在认知、功能、疾病进展和生物标志物等多个方面的益处一起，表明 lecanemab 治疗可能为患者、照顾者和社会带来有意义的益处。
