DRKS00034475尚未招募Unknown
A randomized controlled pilot trial to evaluate the effectiveness and safety of a memory-supporting digital intervention for adult patients with Mild Cognitive Impairment (MCI) and Mild Alzheimer's Dementia (AD) - M3 trial
Cogthera GmbH0 个研究点目标入组 140 人开始时间: 2024年7月3日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 50 Years 至 one（—）
- 性别
- All
入选标准
- •1) Age = 50 years
- •2) Prevalent diagnosis of:
- •MCI (ICD-10: F06.7) to be eligible for Cohort 1, or
- •AD (ICD-10: F00.-*) to be eligible for Cohort 2
- •3) Mini-Mental State Examination (MMSE) Score 20 = to = 27 in the assessment carried out as part of the screening process or in a professional assessment carried out no more than 14 days prior to the screening visit
- •4) Appropriated visual and auditory functions and standard speaking German required for the execution of the intervention and the clinical trial
- •5) Possession of an own mobile device with internet connections
- •a) For Android smartphones and tablets Android 8 or later
- •b) For iPhones and iPads iOS 13 or later
- •6) Ability to use the smartphone, e.g. use E-Mail on the smartphone, SMS, a messenger (WhatsApp, Telegram, Signal) or a Social Platform (Facebook, Instagram, TikTok)
- •7) Ability to understand instructions in German language
- •8) Having access to the Internet and an e-mail address
- •9) Ability to provide written informed consent
- •10) Willingness and ability to comply with all aspects of the clinical trial protocol
- •11) Patients receiving no dementia specific medication at the time of inclusion or patients on a stable dose of dementia specific medication for at least 12 weeks prior to inclusion
排除标准
- •12) Transient ischemic attack, brain tumor, stroke, or seizure within 12 months before study
- •13) Psychiatric symptoms, including: History of diagnosis of other mental disorders than MCI or symptoms that can impede test procedures of the participants (e.g., psychosis or major depressive disorder)
- •14) Nursing Care Grade = 3
- •15) Pregnancy or planned pregnancy within the next three months
- •16) Clinically important abnormalities, that might contribute to or affect the cognitive performance of the patient, for example:
- •a) Abnormal findings in physical examinations, neurological examinations, and vital signs at screening or baseline that, in the opinion of the investigator, may require additional examination or treatment that may interfere with the study procedures or safety
- •b) Other medical conditions (e.g., heart, respiratory, gastrointestinal, kidney
- •disease) that are not adequately stable controlled, in the investigator's opinion, may affect the safety of the subject or interfere with the evaluation of the trial
- •c) Dysarthria or speaking disabilities that, in the opinion of the investigator,
- •probably impede the ability to use the intervention or the participation in
- •the clinical trial
- •d) Visual field defects that, in the opinion of the investigator, will probably impede the ability to use the intervention or the participation in the clinical
- •e) Severe aphasia that, in the opinion of the investigator, will probably impede the ability to use the intervention or the participation in the clinical trial
研究者
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