Justification: In Parkinson’s disease, population above 70 years has more than 50 % prevalence of dementia. The study subjects above 70 years will be more likely to have underlying cognitive decline and varying degrees of dementia. To ensure the validity of our outcome measure we exclude the population that has a higher prevalence of our outcome measure and raise questions about dementia that is our outcome measure and as evident from epidemiological studies people who already have PD dementia have decreased survival time less than five years.1,2
• Parkinson’s disease patients with severe dyskinesia (score > 2 Modified Dyskinesia Scale)
Justification: It may raise ethical issues if subjects with more severe disease are included in the study. It may add additional hardships to their suffering. Also, during their visit to research center more safety measures will need to be taken. They tend to be more unstable in their movements, and their gait and risk of falling is high and may lead to liability issues.
• Evidence (physician diagnosed) of atypical Parkinson syndromes (e.g. Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Cortical-Basal Degeneration (CBD); other causes of dementia based on clinical grounds (e.g. Alzheimer’s disease, vascular dementia, frontotemporal dementia, Creutzfeldt-Jakob disease, Huntington’s Disease);
• People with acute medical problems (e.g. myocardial infarction with congestive heart failure and ejection fraction less than 35, uncontrolled diabetes (HgA1c > 11 and showing no improvement while taking Insulin), advanced Osteoarthritis (people who did not get more than 70% relief from > 3 intra-articular steroid injection)
Justification: Myocardial infarctio...
... middle of paper ...
...res can indicate severe (≤9 points), moderate (10–18 points) or mild (19–23 points) cognitive impairment.
• Subjects will be evaluated based on MMS (Mini-mental state examination) every one year.
•Any person who develops cognitive impairment within one year of diagnosis of Parkinson 's disease.
•Participant with the onset of cognitive impairment before Parkinson 's disease diagnosis with the onset of cognitive impairment before Parkinson’s disease will be excluded from the study, as the diagnosis would be Lewy body dementia.
•The complete data is password protected.
•The data is accessible only to investigators who are involved in the study.
•The Identity-names of the subjects will be given a designated number, and the document will be strictly accessible only by the Investigators.
•Digital signature can be used for data protection.
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