Comparative Study Between Parkinson's Disease and Parkinson Dementia Complex : Genetics, Clinical, Neurophysiological
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Score on MDS-UPDRS
研究概览
简要总结
To compare between Idiopathic PD versus Parkinson-Dementia complex using different modalities: Demographic, Clinical, genetic, Psychometric and electrophysiologically
详细描述
Parkinson's disease (PD), is one of the commonest neurodegenerative disorders with a severe progressive course and major impact on patients' quality of life. The development of late-onset PD likely results from the interaction of genetic and environmental factors in the context of brain aging.
Although several environmental exposures have been implicated, evidence for their causal contributions is limited.
PD in Egypt is a rapidly emerging concern as prevalence rose by 40.7% between 1990 and 2016, one of the highest increases in the world. which influences us to dig further in the genetic basis behind the scenes leading to that leap.
Cognitive impairment in PD constitutes a major source of disease burden for patients and families, and has a significant negative effect on patients' quality of life. Cognitive impairment without dementia is designated as mild cognitive impairment of PD (PD-MCI), where the activities of daily living are grossly preserved, whereas dementia associated with PD is designated as PD-D.
Parkinson's disease dementia is a neurofibrillary tangle degeneration involving the deposition of Alzheimer-type tau, predominantly in the mesial temporal cortex, brainstem, and basal ganglia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •All participants must fulfill the following inclusion criteria of UINTED KINGDOM bank criteria of PD Men or women of at least 50-80 years of age.
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow up.
- •Medically stable outpatients with confirmed diagnosis of idiopathic PD according to United Kingdom Brain Bank Criteria
- •Clear written informed consent from each participant in the trial.
- •Patients after at least 6 h free of parkinsonian drugs (off-state).
- •For the Parkinson's Dementia Complex group, dementia must be evident through history taking or clinical examination
排除标准
- •Pregnants, breastfeeding, or willing to be pregnant during the study.
- •Presence of clinically significant medical or psychiatric condition that may increase the risk associated with the study
- •Participation in any other type of medical research that may interfere with the interpretation of the study.
- •Patients with severe motor disability (bed-ridden ) that may interfere with the study procedure.
- •History of surgical or invasive intervention for Parkinson disease.
- •Patients with history of seizures or epilepsy including history in a first degree relative or patients on treatment that reduce seizure threshold.
- •For the Parkinson's Dementia Complex group, Subject with dementia due to other diseases or with Parkinson's dementia complex and contribution of other disorders (Mixed dementia)
- •Brain imaging suggesting another diagnosis.
结局指标
主要结局
Score on MDS-UPDRS
时间窗: through study completion, an average of 1 year
Score on MDS-UPDRS
Score on mini mental state examination
时间窗: through study completion, an average of 1 year
Score on mini mental state examination
次要结局
- Score on PDQ-39(through study completion, an average of 1 year)
- Score on Score on Montreal Cognitive Assessment(through study completion, an average of 1 year)
研究者
Eman M. Khedr
Professor doctor
Assiut University