The Swedish BioFINDER - Preclinical AD Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Change in cognitive function
研究概览
简要总结
This research study aims to examine biomarkers of Alzheimer's disease (AD) as early as possible which could potentially be a screening tool for the general population. This observational study will take place at the Skåne University Hospital in Sweden. The study will enroll up to 600 cognitively healthy subjects aged 50 to 80 years with 3/4 having preclinical Alzheimer's disease. Recruitment and enrollment will be ongoing for 2-3 years, and subject participation will be lasting approximately 4 years. Disclosure of AD risk assessments will be an optional procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 50-60 require at least one of the following risk factors for AD:
- •Known apolipoprotein E (APOE) -ε4 carrier
- •Known 1st degree family history of dementia or severe memory loss with onset prior to
- •Known amyloid brain pathology by either CSF or PET scan.
- •Mini-Mental State Examination (MMSE) ≥26 (aged >65); MMSE ≥27 (aged 50-65).
- •Score of 12 or above on the Montreal Cognitive Assessment (MoCA) telephone version.
- •Speaks and understands Swedish to the extent that an interpreter is not necessary to fully understand the study information and cognitive tests.
- •6a. Preclinical Alzheimer's disease subgroup (n=450): Amyloid pathology according to cerebrospinal fluid Alzheimer's disease and amyloid PET scans.
- •6b. Non-Preclinical Alzheimer's disease subgroup (n=150): No sign of preclinical Alzheimer's disease using cerebrospinal fluid Alzheimer's disease biomarkers or Aβ-PET scans.
排除标准
- •Fulfils the criteria for minor or major neurocognitive disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- •History of significant brain injury or other known neurologic disease or insult, resulting in lasting cognitive sequelae that would confound the assessment and staging of potential neurodegenerative disease.
- •Major depression, bipolar disorder, or recurrent psychotic disorders within the past year.
- •History of alcohol and/or substance abuse or dependence within the past year.
- •Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
- •Refusing or unable to complete baseline cognitive and biomarker assessments (i.e., cognitive testing, blood draw, MRI and PET).
研究组 & 干预措施
Cognitively unimpaired individuals with preclinical Alzheimer's disease
75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
干预措施: Plasma tau (Diagnostic Test)
Cognitively unimpaired individuals with preclinical Alzheimer's disease
75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
干预措施: Plasma β-Amyloid 42/40 (Aβ42/Aβ40) (Diagnostic Test)
Cognitively unimpaired individuals with preclinical Alzheimer's disease
75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
干预措施: Flutemetamol F18 Injection (Diagnostic Test)
Cognitively unimpaired individuals with preclinical Alzheimer's disease
75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
干预措施: [18F]-RO6958948 Injection (Diagnostic Test)
Cognitively unimpaired individuals with preclinical Alzheimer's disease
75% of the recruited population will be cognitively unimpaired individuals with preclinical Alzheimer's disease.
干预措施: Magnetic resonance imaging (MRI) (Diagnostic Test)
Cognitively unimpaired individuals without preclinical Alzheimer's disease.
25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
干预措施: Plasma tau (Diagnostic Test)
Cognitively unimpaired individuals without preclinical Alzheimer's disease.
25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
干预措施: Plasma β-Amyloid 42/40 (Aβ42/Aβ40) (Diagnostic Test)
Cognitively unimpaired individuals without preclinical Alzheimer's disease.
25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
干预措施: Flutemetamol F18 Injection (Diagnostic Test)
Cognitively unimpaired individuals without preclinical Alzheimer's disease.
25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
干预措施: [18F]-RO6958948 Injection (Diagnostic Test)
Cognitively unimpaired individuals without preclinical Alzheimer's disease.
25% of the recruited population will be cognitively unimpaired individuals without preclinical Alzheimer's disease.
干预措施: Magnetic resonance imaging (MRI) (Diagnostic Test)
结局指标
主要结局
Change in cognitive function
时间窗: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of cognitive decline as measured by traditional cognitive and behavioral assessments including The Preclinical Alzheimer Cognitive Composite (PACC)
Change in cognitive function - digital assessment
时间窗: Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.
Rate of cognitive decline as measured by digital cognitive assessments
次要结局
- Rate of change in cerebrospinal fluid biomarkers(Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.)
- Rate of change in plasma biomarkers(Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every year for 4 years after baseline.)
- Rate of change in CSF biomarkers(Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.)
- Rate of change in amyloid PET(Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.)
- Rate of change in tau PET(Time zero equals the baseline visit. All subjects will subsequently attend follow-up visits every two years for 4 years after baseline.)
研究者
Erik Stomrud
M.D., PhD
Skane University Hospital