ISRCTN17035495已完成未知
A prospective pilot study to evaluate the feasibility of conducting smartphone-based remote self-assessments of cognition, function, and behavior in individuals with subjective cognitive decline, early Alzheimer's disease, and healthy controls
Roche (United States)0 个研究点目标入组 120 人开始时间: 2020年11月10日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
2022 Abstract results in https://doi.org/10.14283/jpad.2022.97 P150, P152, P153, P209 (added 03/01/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent form
- •2. Age 65 years or above
- •3. Previous experience with smartphone or tablet technology
- •4. Fluency in the language of the tests used at the study site
- •5. Adequate visual and auditory acuity, in the investigator’s judgment, sufficient to perform the neuropsychological testing
- •6. Willingness and ability to complete all aspects of the study (including brain MRI and PET imaging [if applicable])
- •7. Availability of a study partner throughout the study and which agrees to provide information and to complete all aspects of the study at clinic visits
排除标准
- •1. Unable to comply with the study protocol, in the investigator’s judgment
- •2. History or known presence of any significant neurological disorders such as Parkinson’s disease, multiple sclerosis, traumatic head injury, territorial infarct or brain tumor with cognitive sequelae
- •3. History or known presence of any significant psychiatric disorder such as schizophrenia, bipolar disorder, substance use disorders
- •4. Current active clinically significant anxiety or depressive disorder (moderate anxiety or depression as judged by the investigator) that is likely to impede a participant's ability to participate in the study
- •5. Current use of any medication that could affect cognitive performance (e.g. benzodiazepines, etc.)
- •6. Participation in any interventional AD clinical study including studies with digital assessments within the past 6 months at the time of screening
- •7. Any significant cerebral abnormalities or significant MRI finding such as ischemic or hemorrhagic strokes as confirmed by the central reader.
- •8. Inability to tolerate MRI procedures or contraindication to MRI, including but not limited to, presence of pacemakers not compatible with MRI, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that would contraindicate an MRI scan, or any other clinical history or examination finding that, in the judgment of the investigator, would pose a potential hazard in combination with MRI
- •9. In addition, for participants with SCD and healthy controls: Prior diagnosis and/or treatment for a memory disorder
研究者
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