Cognitive Function and Prevalence of Amyloid Marker in Frail Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 344
- 试验地点
- 2
- 主要终点
- Amyloid physiological parameter
研究概览
简要总结
The current study seeks to examine the prevalence of amyloid pathology, among patients referred to the Toulouse Geriatric Frailty Clinic presenting objective memory impairment. We also aim to fully characterize the clinical progression of frail cognitively impaired patients presenting AD (Alzheimer Disease) pathology vs those who also present a cognitive impairment but do not have AD pathology.
详细描述
The COGFRAIL study is a monocentric study integrating the longitudinal follow-up of 345 individuals referred to the Toulouse Frailty Clinic during 2 years. The procedure consists in neuroimaging to diagnose the presence of amyloid plaques in the brains and permit earlier detection of Alzheimer's disease.
- Visits will be scheduled at baseline, 1 and 2 years for a full neuropsychological, functional and physical evaluation.
- At 6 and 18 months patients will be seen in consultation by a Geriatrician and research assistant for a medical check.
- PET-Scan will be scheduled in the 2 months following inclusion for amyloid measurements. The MRI will be proposed, depending on the clinical relevance
- A blood sample for biobank will be taken at visit 2 and at the end of the study
Extension study (CogFrail-Plus):
The extension study will integrate an additional 2 years follow-up of the
COGFRAIL study participants, following the initial 2 years period of the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male individuals referred to the Toulouse Frailty Clinic with an objective memory impairment (CDR=0.5 or CDR=1)
- •Age ≥ 70 years
- •At least 1 Fried-criterion
- •Informed consent signed by the patient
- •Having an informant accompanying or available by phone
- •Individuals affiliated to a healthcare scheme.
- •- Willing to be informed in case of a new pathology discovered through medical examination
- •Extension study (Cog-Frail Plus):
- •COGFRAIL study participants still included in the study and completing their last visit (M 24)
- •Having a family member or legal representant to sign the consent form if MMSE score <20 at the last visit (M24)
排除标准
- •Individuals presenting severe visual or auditory difficulties which may interfere with the completion of neuropsychological and functional assessments.
- •Presence of any pathology or severe clinical or psychological condition that, according to the investigator, might interfere with study results or may expose the participants to additional risks.
- •Individuals who are robust according to the Fried criteria (0 criteria)
- •Individuals who are dependent (Activities of Daily Living (ADL) <4)
- •Individuals who have a major deterioration in global cognitive function (Mini Mental State Examination (MMSE) <20)
- •Subjects deprived of their liberty by administrative or judicial decision, or under guardianship or admitted to a healthcare or social institution (subjects in non-assisted living facilities could be recruited);
- •Exclusion criteria for MRI scanning :
- •Claustrophobia
- •Trauma or surgery which may have left ferromagnetic material in the body, including pacemakers
- •History of neurosurgery or aneurism
- •Extension study (Cog-Frail Plus):
- •Presence of any severe pathology that, according to the investigator, might interfere with study results or may expose the participants to additional risks.
- •Subjects deprived of their liberty by administrative or judicial decision, or under guardianship
研究组 & 干预措施
neuroimaging amyloid diagnosis by MRI and PET scan
There is only one arm. The procedure consists in neuroimaging to diagnose the presence of amyloid plaques in the brains and permit earlier detection of Alzheimer's disease. MRI and PET Scan.
- Visits at baseline, 1 and 2 years for a full neuropsychological, functional and physical evaluation.
- At 6 and 18 months in consultation by a Geriatrician and research assistant for a medical check.
- one PET-Scan in the 2 months following inclusion for amyloid measurements and one MRI, depending on the clinical relevance
- A blood sample for biobank at visit 2 and at visit 5.
Extension study (CogFrail-Plus): additional 2 years follow-up of the COGFRAIL study participants, following the initial 2 years period of the study:
- 2 Visits at at 36 and 48 months for a full neuropsychological, functional and physical evaluation
- At 30 and 42 months in consultation by a Geriatrician and research assistant for a medical check
- A blood sample at 36 and 48 months.
干预措施: MRI and PET scan (Procedure)
结局指标
主要结局
Amyloid physiological parameter
时间窗: 2 months after inclusion
Amyloid pathology as corroborated with amyloid Positron Emission Tomography (PET) or lumbar punction
次要结局
- Changes in functional capacities with scales ADL(12 and 24 months)
- Changes in functional capacities with scales SPPB(12 and 24 months)
- Change in cognitive function with Clinical Dementia Rating Scale (CDR)(12 and 24 months)
- Changes in functional capacities with scales IADL(12 and 24 months)