Study of Behavioural and Psychological Symptoms as Functional Prognostic Factors in Neurodegenerative Early Onset Major Neurocognitive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- BADL dependency in both bathing and dressing at 18 months
研究概览
简要总结
NEODEM is a multicenter cohort study of patients with early-onset degenerative dementia (before age 65), the main objective of which is to study behavioral disorders and in particular depression as functional prognostic factors at 3 years.
详细描述
Early-onset dementia (EOD), which begins before the age of 65, is less common than late-onset dementia but represents a significant burden for the patient, their family and the healthcare system. The descriptive epidemiology is poorly known, and the National Reference Center for young patients, using English data (Harvey et al., 2003) estimates the number of subjects concerned in France at 18,318. It is degenerative dementia that is the most common cause of EOD and among them, Alzheimer's disease and then frontotemporal degeneration (FTD) (Vieira et al., 2013). The natural history and prognostic factors of PDD are not well known, and only AD has some data. Alzheimer's disease (AD) in young people appears to have a worse prognosis than that in older people, but this is debated (Stanley and Walker, 2014) and also depends on the criteria studied: cognition, function or survival. Prognostic factors other EOD, and in particular frontotemporal dementias, which moreover are heterogeneous pathologies, are even less known.
Investigators have chosen to study the functional prognosis of patients because it is both very relevant to care needs and easy to measure. Among the prognostic factors of functional status, investigators will study in particular psycho-behavioral disorders, and in particular depression, which is very common in patients with EOD, a factor of poor quality of life and accessible to treatment. Other potential prognostic factors such as cognitive reserve, gender, clinical variants of AD and DFT, family status (living alone or having a caregiver), genetic status, family history of dementia, CSF biomarkers and MRI imaging will be studied . The evolution of instrumental activities of daily living will be measured. The social and paramedical resources used by the patient and his family will be collected, as well as the use of psychotropic and non-drug treatments. Finally, the overall evolution of the severity of dementia will be measured.
Eligible patients will be included for 3 years and evaluated every 6 months.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed neurodegenerative (within 6 months) EOD according to international consensus criteria
- •Symptoms onset before 65 years old
- •Clinical Dementia Rating Scale (CDR) 0.5 to 1 both inclusive
- •Affiliated person or beneficiary of a social security scheme.
- •Free and informed consent obtained and signed by the patient or by the patient's representative and a non-opposition letter signed by the caregiver when available
- •Able to participate to cognitive and psychiatric assessments
排除标准
- •Non degenerative dementias : e;g. vascular, alcohol-related, toxic, infectious, posttraumatic.
- •Dementia of unknown etiology
- •Dementia in Down syndrome
- •Patients in Nursing Home or other care facility
- •Total dependency for dressing and/or bathing at the time of inclusion
- •Patient with a severe or life-threatening disease
结局指标
主要结局
BADL dependency in both bathing and dressing at 18 months
时间窗: 18 months after inclusion
Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding.. It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016). Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point). A total score of 0 indicates "full function" and 12 indicates "severe functional impairment". To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if \<4.
BADL dependency in both bathing and dressing using the BADL scale from Katz (Katz et al., 1970) at inclusion
时间窗: at inclusion
Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding.. It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016). Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point). A total score of 0 indicates "full function" and 12 indicates "severe functional impairment". To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if \<4.
BADL dependency in both bathing and dressing at 30 months
时间窗: 30 months after inclusion
Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding.. It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016). Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point). A total score of 0 indicates "full function" and 12 indicates "severe functional impairment". To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if \<4.
BADL dependency in both bathing and dressing at 36 months
时间窗: 36 months after inclusion
Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding.. It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016). Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point). A total score of 0 indicates "full function" and 12 indicates "severe functional impairment". To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if \<4.
BADL dependency in both bathing and dressing using the BADL scale from Katz (Katz et al., 1970) at 6 months
时间窗: 6 months after inclusion
Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding.. It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016). Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point). A total score of 0 indicates "full function" and 12 indicates "severe functional impairment". To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if \<4.
BADL dependency in both bathing and dressing at 12 months
时间窗: 12 months after inclusion
Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding.. It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016). Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point). A total score of 0 indicates "full function" and 12 indicates "severe functional impairment". To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if \<4.
BADL dependency in both bathing and dressing at 24 months
时间窗: 24 months after inclusion
Katz scale ranks the adequacy of performance in six basic functions including bathing, dressing, toileting, transferring,continence, and feeding.. It has been shown that bathing and dressing are the first ADL to be lost, also defined by Katz et al. as the thresholds for disability (Katz et al., 1970 ; Edjolo et al., 2016). Each item is graded according to the level of dependence as follows: performs independently (0 point), performs with assistance (1 point), and unable to perform (2 point). A total score of 0 indicates "full function" and 12 indicates "severe functional impairment". To evaluate the primary outcome, only the score at the two first items (bathing and dressing, scoring from 0 to 4) will be taken into account for the analysis: complete dependency is present if the score at the two first items is 4 and absent if \<4.
次要结局
- BPSD as measured by NPI at 12 months after inclusion(at 12 months after inclusion)
- Depression as measured by the Cornell Scale for Depression in Dementia at 36 months after inclusion(at 36 months after inclusion)
- Behavioral and Psychological Symptoms of Dementia (BPSD) as measured by Neuropsychiatric Inventory (NPI) at the inclusion(at the inclusion)
- Institutionalization(at 36 months after inclusion)
- BPSD as measured by NPI at 24 months after inclusion(at 24 months after inclusion)
- Depression as measured by the Cornell Scale for Depression in Dementia at inclusion(at inclusion)
- Depression as measured by the Cornell Scale for Depression in Dementia at 12 months after inclusion(at 12 months after inclusion)
- Death(at 36 months after inclusion)
- Depression as measured by the Cornell Scale for Depression in Dementia at 24 months after inclusion(at 24 months after inclusion)
- BPSD other than depression at inclusion(at inclusion)
- BPSD as measured by NPI at 36 months after inclusion(at 36 months after inclusion)
- BPSD other than depression at 12 months after inclusion(at 12 months after inclusion)
- BPSD other than depression at 24 months after inclusion(at 24 months after inclusion)
- BPSD other than depression at 36 months after inclusion(at 36 months after inclusion)