PACTR202407499314703尚未招募Unknown
Multi-National Implementation of Multimodal Strategies to promote Healthy Brain Ageing in Sub-Saharan Africa (The AFRICA-FINGERS Project)
Aga Khan University kenya0 个研究点目标入组 600 人开始时间: 2024年7月11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
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45 Year(s) 至 64 Year(s)（—）
- 性别
- All
入选标准
- •1. Age 50 – 85 years.
- •2. CAIDE Dementia Risk Score =6 points (based on age, sex, education, systolic blood pressure, BMI, total cholesterol, and physical activity; range 0–14 points). The CAIDE risk score will be calculated based on data already collected as part of the relevant register or newly collected as part of the screening for lifestyle process.
- •3. Cognitive performance at the mean level or slightly lower than expected for age according to local population norms. The aim of this screening for lifestyle is to exclude individuals with substantial cognitive impairment/dementia, but also high performers, with low likelihood of change over 24 months. The cognitive screening for lifestyle will be based on the IDEA test.
- •4. Proficiency in the local language i.e. fluency and literacy in English and/or major traditional dialect Swahili (Kiswahili), Igbo or Yoruba
- •5. Able to consent
- •6. Any medication affecting cognition must have a stable dose for =4 weeks.
排除标准
- •1. Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician). IDEA-IADL score =10), or high functioning level (IDEA > age-adjusted 70th centile
- •2. Current or past use of medications for AD or related diseases (e.g., cholinesterase inhibitors, memantine).
- •3. Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical judgement.
- •4. Other known significant neurologic disease, including but not limited to Parkinson’s disease, Huntington’s disease, normal pressure hydrocephalus, brain tumor, progressive, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities.
- •5. Any other condition affecting safe engagement in the intervention, e.g. malignant disease, major depression, symptomatic cardiovascular disease, revascularization within the previous year.
- •6. Severe loss of vision, hearing, or communicative ability; conditions preventing cooperation as judged by the study physician.
- •7. Coincident participation in the active phase of another intervention trial.
- •8. Severe health conditions/recent surgical or other major procedures preventing safe intervention engagement/ trial participation as judged by study physician (e.g., severe sensory impairment; on-going major psychiatric illness)
- •Exclusion criteria affecting the engagement in the intervention will be evaluated by the study physician for those meeting the cognitive inclusion criteria. Internet literacy will be also evaluated to ensure that each participant is willing to engage with the remote components of the intervention.
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