Progression in Cognition and Associated Activities of Daily Living (ADL) Impairment in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Diagnosis of Parkinson's disease dementia (PDD) / Level II diagnosis of mild cognitive impairment in Parkinson's disease (PD-MCI)
研究概览
简要总结
Mild cognitive impairment (PD-MCI) is one of the greatest risk factors for future Parkinson's disease dementia (PDD). A recent meta-analysis found that, on average, 31% of patients with PD-MCI converted to PDD within seven years; however, 24% of patients with PD-MCI reverted back to normal cognitive function. Consequently, the false positive rate for predicting PDD among patients with PD-MCI is high, and better predictive markers to define patients at high risk for PDD development are urgently needed. Therefore, a combination of different markers, including clinical, genetic, and other biomarker data, are proposed to increase ability to predict cognitive worsening and dementia. Based on data of the first follow-up of this cohort results indicated that presence of both mild cognitive instrumental activities of daily living (IADL) impairment and PD-MCI dramatically increases the risk for PDD (PubMed ID: 36240089). This study evaluates markers predicting cognitive and IADL long-term outcome in our sample. Additionally, focus of the study is the investigation whether ratings of patients or informants best predicted decline of cognitive impairment and/or everyday function. Clinical data along with other clinical marker and biomarker status will be investigated.
详细描述
Patients assessments: Most scales (except for Kölner Apraxie Test) were also included in the first follow-up of the sample. Total duration of scales and questionnaires is 4 hours (total time of mandatory in house assessments: 115 min).
Demographic and lifestyle data: Age, gender, education, occupation, family history of neurodegenerative diseases, smoking/drinking behavior, height & weight will be registered.
Activities of daily living assessment: The total and subscores of the Pfeffer Functional Activities Questionnaire (score range 0 to 30 higher values indicating more impairment) will be assessed. Additionally patients assessment includes the Parkinson's disease Activity of daily living scale (five level scale, higher values indicating more impairment).
Neuropsychological Assessment: History and self-awareness of cognitive deficits will be asked. Overall mean z-score (range -3.00 poor performance to +3.00 excellent performance) and cognitive domain score (mean z-score of tests assigned to one domain) will be quantitatively assessed using the Consortium to Establish a Registry for Alzheimer's Disease (CERAD-Plus) battery, three subtests of the Wechsler Intelligence Test for Adults (WIE), and one subtest of the Leistungsprüfsystem für 50- bis 90-Jährige (LPS 50+). The MMSE included in the CERAD-Plus, as well as the Montreal Cognitive Assessment (MoCA) will serve as global cognitive screening scales.
- Executive functions: Lexical and Phonemic Fluency (CERAD-Plus), Trail Making Test Part B (CERAD-Plus)
- Attention/working memory: Digit-Symbol Test (WIE), Letter-Number Sequencing (WIE)
- Language: Boston Naming Test (CERAD-Plus), Similarities (WIE)
- Memory: Word List Learning, Recall, and Discriminability (CERAD-Plus), Praxis Recall (CERAD-Plus)
- Visuospatial abilities: Praxis (CERAD-Plus), Fragmented Words (LPS-50+)
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant in the " Amyloid-Beta in cerebrospinal fluid as a risk factor for cognitive dysfunction in Parkinson's Disease" (ABC-PD) study
- •Diagnosis of Parkinson's disease according to the United Kingdom Brain Bank criteria.
- •Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
- •Provide written informed consent to participate in the study and understand the right to withdraw consent at any time without prejudice to future medical care.
- •If people with Parkinson's disease are not able to give consent for study participation (confirmed by an independent physician), study consent of a legal guardian is required.
排除标准
- •Any disability that may prevent the subject from completing the informed consent form or other study requirements.
- •Other neurodegenerative disease which renders the subject unable to communicate well with the investigator or to understand and comply with the requirements of the study.
- •Participation in any clinical investigation of a new investigational compound or therapy within 4 weeks prior to baseline visit, and any other limitation of participation based on local regulations.
- •Alcohol, medication, or drug dependency or abuse (except for nicotine).
- •History of brain disease other than Parkinson's disease, e.g., head trauma, stroke, encephalitis.
结局指标
主要结局
Diagnosis of Parkinson's disease dementia (PDD) / Level II diagnosis of mild cognitive impairment in Parkinson's disease (PD-MCI)
时间窗: 6-8 years
Patients will be classified as PD-MCI according to Level-II Movement Disorder Society recommendations if cognitive impairment was present but did not significantly interfere with everyday function \[PubMed ID: 21661055\] according to a personalized interview. PDD was defined according to Movement Disorder Society Task Force criteria \[PubMed ID: 18098298\] if cognitive impairment was present and severe enough to impair activities of daily living function unrelated to motor or autonomic symptoms. Cognitive impairment will be defined according to Level-I (impairment of global cognition) for patients with minimal assessments, or Level-II (performance below 1.5 standard deviation of the population mean reported in the test manuals on at least two tests) for patients assessed using a full cognitive battery. Assessment include a detailed neuropsychological test battery (see below).
次要结局
- Pfeffer Activities of daily living scale(6-8 years)
- Follow-up score in global cognition(6-8 years)
- Follow-up cognitive domain performance(6-8 years)