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CTRI Number  CTRI/2024/06/068650 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 10/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study to detect a link between duration of illness and Cognitive decline in patients with Parkinson’s disease. 
Scientific Title of Study   A Clinical Profile of Parkinsons disease and association of disease duration with cognitive impairment. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shlok Bharadwaj 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Medicine, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8005908821  
Fax    
Email  bharadwaj.shlok@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shubha Seshadri 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Medicine, Kasturba Medical College, MAHE, Madhav Nagar, Manipal, Udupi, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  8202922129  
Fax    
Email  shubhamanipal@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Shlok Bharadwaj 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Medicine, Kasturba Medical College, Manipal


KARNATAKA
576104
India 
Phone  8005908821  
Fax    
Email  bharadwaj.shlok@gmail.com  
 
Source of Monetary or Material Support  
Kasturba medical college, MAHE, Madhav Nagar, Manipal, Udupi, Karnataka, India, 576104 
 
Primary Sponsor  
Name  Shlok Bharadwaj 
Address  Department of Medicine, Kasturba Medical College, Manipal, Udupi, 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shlok Bharadwaj  Kasturba Hospital, Manipal  Department of Medicine and Department of Neurology, Kasturba Medical College, Madhav Nagar, Manipal 576104
Udupi
KARNATAKA 
8005908821

bharadwaj.shlok@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kasturba medical college and kasturba Hospital institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients admitted to Kasturba Hospital and coming to neurology or medicine OPD with PD fulfilling the UKPDS Brain Bank Criteria will be included.

Included patients should be able to read English, or Kannada.

18 years of age and above.  
 
ExclusionCriteria 
Details  Patients unable to read or write.

The patient admitted to KH with acute neurological or neuropsychiatric illness.

The patient is also having other underlying condition known to cause cognitive impairment: -
1. Hypothyroidism
2. Chronic kidney disease
3. Chronic liver disease

Patients excluded by UKPDS Brain Bank Criteria: -
1. History of Cerebrovascular Disease
2. History of significant Head injury
3. Previous encephalitis
4. Drug or alcohol abuse
5. Features of Parkinsonism plus syndromes.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation between SCOPA COG score and time since disease diagnosis in patients with PD  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
to make a clinical profile of PD patients visiting tertiary care centre in south india  Baseline 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Parkinson’s disease is one of the most common neurodegenerative diseases. Cognitive dysfunction and dementia are common in Parkinson’s disease, and the presence of dementia appears to be an independent predictor of mortality in PD. There is a distinct  Lack of studies on cognitive impairment in PD patients from India.  Along with the highly variable clinical course and progression of disease and dementia,  the underlying pathologic and anatomical basis of dementia in PD is also poorly understood.  Recognition of cognitive dysfunction early is important to improve therapeutic outcomes and prevent complications.  This trial aims to describe the epidemiological and clinical characteristics of patients with Parkinson’s disease presenting to a tertiary care hospital in India with a special focus on cognitive profile with special focus on comparing cognitive impairment in groups of Parkinson’s disease patients with duration of disease. This study will help in identifying patients at risk for developing cognitive impairment as well as identifying clinical markers associated with cognitive decline in patients with PD. This would be helpful as potential for new therapeutic options to delay or prevent cognitive impairment would be best in early phase or preclinical stage of disease.  

 
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