在基于人群的认知衰老研究中参加donanemab试验的资格
Katherine E Jones1, Jeremiah A Aakre2, Anna M Castillo2
1Department of Neurology, Mayo Clinic, Rochester, MN, USA; Wake Forest University, Winston-Salem, NC, USA.
The journal of prevention of Alzheimer's disease
|February 18, 2025
概括
很少有轻度认知障碍或阿尔茨海默病的参与者符合donanemab试验标准. 主要的排除包括神经成像发现,中枢神经系统条件和以前的恶性病史.
科学领域:
- 神经学 神经学
- 神经成像是一种神经成像.
- 临床试验 临床试验
背景情况:
- 阿尔茨海默病 (AD) 诊断依赖于临床综合征,粉样蛋白负担和病理.
- 多纳尼马布是一种针对聚合性粉样β斑块的研究性抗体.
- 获得第三阶段试验资格需要特定的生物标志物和临床资料.
研究的目的:
- 评估梅奥诊所衰老研究的参与者是否有资格参加donanemab第3期试验.
- 确定影响轻度认知障碍 (MCI) 或轻度AD痴呆症患者试验资格的关键排除标准.
主要方法:
- 对817名患有MCI或轻度AD痴呆症的参与者 (60-85岁) 的回顾性分析.
- 应用微型精神状态检查 (MMSE) 标准 (20-28) 和排除成像禁忌.
- 评估粉样PET和PET (18F-flortaucipir) 状态,以及其他特定于试验的标准.
主要成果:
- 最初对817名参与者的查将样本减少到769名.
- 275个含有粉胺PET的,其中130个具有并发性tauPET.
- 只有23% (13在56名粉样蛋白阳性参与者中与tau PET) 满足了所有donanemab试验资格标准.
结论:
- 很大一部分患有MCI或轻度AD痴呆症的个体不符合donanemab第3期试验的资格标准.
- 神经成像发现,中枢神经系统排除和恶性瘤史是被取消资格的主要原因.
- 改进资格标准可能是必要的,以扩大参与阿尔茨海默病研究的试验.
相关概念视频
01:26Alzheimer's Disease: Overview
429
Alzheimer's Disease (AD) is a continually advancing neurodegenerative disorder, distinguished by escalating memory loss, cognitive dysfunction, and dementia. The disease unfolds in three stages: preclinical, mild cognitive impairment (MCI), and dementia. Its onset is insidious, and the progression gradual, with the cause not well explained by other disorders.
The clinical diagnosis of AD hinges on the presence of memory and other cognitive impairments. Biomarkers, such as changes in Aβ...
The clinical diagnosis of AD hinges on the presence of memory and other cognitive impairments. Biomarkers, such as changes in Aβ...
429
01:22Alzheimer's Disease: Treatment
150
Alzheimer's Disease (AD), a neurodegenerative disorder, is pathologically identified by amyloid plaques and neurofibrillary tangles composed of tau protein. AD pharmacotherapy aims to manage cognitive symptoms, delay disease progression, and treat behavioral symptoms. The treatment is primarily symptomatic and palliative, with no definitive disease-modifying therapy available. Cholinesterase inhibitors, including donepezil (Aricept), rivastigmine (Exelon), and galantamine (Razadyne), are...
150
01:30Cognitive Development During Adulthood
45
Cognitive development continues throughout adulthood, undergoing significant shifts across early, middle, and late stages. Individual transition occurs from adolescent idealism to pragmatic and adaptable thinking in early adulthood. During this period, individuals learn to integrate personal beliefs with the recognition that other perspectives are equally valid. Exposure to the complexities of modern society, diverse experiences, and higher education contribute to this adaptive thought process,...
45
01:30Dementia
91
Dementia is a collective term for cognitive disorders primarily affecting memory, thinking, and reasoning. It is not a specific disease but a syndrome, with Alzheimer's disease being the most common cause, accounting for approximately 60-80% of cases. Other types include vascular dementia, Lewy body dementia, and frontotemporal dementia. Dementia affects millions worldwide, particularly older adults, though it is not a normal part of aging.
The progression of dementia is generally gradual....
The progression of dementia is generally gradual....
91
01:30Cognitive Enhancers: Cholinesterase Inhibitors and NMDA Receptor Antagonists
95
Cognitive enhancers, also known as "smart drugs," are substances used to enhance memory, mental alertness, and concentration. These can be natural or synthetic and improve cognition in conditions like Alzheimer's disease (AD) and other neurodegenerative diseases. Some common examples include caffeine, amphetamines, methylphenidate, modafinil, arecoline, donepezil, vortioxetine, and piracetam. These enhancers work on the principle of synaptic plasticity and altered circuit function.
95