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CTRI Number  CTRI/2018/02/011948 [Registered on: 19/02/2018] Trial Registered Prospectively
Last Modified On: 24/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Study to assess safety, tolerability and effectiveness in patients with severe dementia exposed to exelon 
Scientific Title of Study   A prospective, 16 week, phase IV study to evaluate safety, tolerability and effectiveness in patients with severe dementia of the Alzheimer’s type exposed to rivastigmine (Exelon)15cm2 transdermal patch 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CENA713DIN01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Sneha Thakur 
Designation  Lead Medical Advisor 
Affiliation  Novartis India Limited 
Address  The Inspire BKC Part of 601 & 701,G-Block, BKC Main Road, Bandra Kurla Complex, Bandra East, Mumbai
The Inspire BKC Part of 601 & 701,G-Block, BKC Main Road, Bandra Kurla Complex, Bandra East, Mumbai - 400051
Mumbai
MAHARASHTRA
400051
India 
Phone  912250243632  
Fax  912250243005  
Email  sneha.thakur@novartis.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Sneha Thakur 
Designation  Medical Advisor 
Affiliation  Novartis India Limited 
Address  The Inspire BKC Part of 601 & 701,G-Block, BKC Main Road, Bandra Kurla Complex, Bandra East, Mumbai
The Inspire BKC Part of 601 & 701,G-Block, BKC Main Road, Bandra Kurla Complex, Bandra East, Mumbai - 400051
Mumbai
MAHARASHTRA
400051
India 
Phone  912250243632  
Fax  912250243005  
Email  sneha.thakur@novartis.com  
 
Source of Monetary or Material Support  
Novartis India Limited, Medical Dept., Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai 400 018. INDIA.  
 
Primary Sponsor
Modification(s)  
Name  Novartis India Limited 
Address  The Inspire BKC Part of 601 & 701,G-Block, BKC Main Road, Bandra Kurla Complex, Bandra East, Mumbai  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kishalaya Karan  Apollo Multispecialty hospitals Ltd  58, Canal Circular road, Kolkata- 700054, West Bengal, India
Kolkata
WEST BENGAL 		 9231864907

drkishalaya@gmail.com 
Dr Anil Ramakrishna  Bhagwan Mahaveer Jain Hospital  Room no.43, 1st floor, Old block,Neurology department, Millers road, Vasanth Nagar, Bangalore - 560 052
Bangalore
KARNATAKA 		 9886256153

anilrb9@gmail.com 
Dr Manoj Hunnur  BhaktiVedanta Hospital and Research Institute  Srishti Complex, BhaktiVedanta Swami Marg, Mira Road (East), Thane – 401107, Maharashtra, India
Thane
MAHARASHTRA 		 9867957022
02228459885
drhunnurmt@gmail.com 
Dr Guruprasad Hosurkar  Columbia Asia Referral Hospital  Clinical research department, basement,26/4, Brigade gateway, Malleshwaram West, Beside Metro, Bangalore
Bangalore
KARNATAKA 		 09008933554
8030925688
guruhosurkar@gmail.com 
Dr Debashis Chakraborty  Fortis Hospital  Room no. 106,Ground floor/Level 1, 730,Anandpur,Kolkata - 700107
Kolkata
WEST BENGAL 		 9831172219

chakraborty_debashis@hotmail.com 
Dr Hrishikesh Kumar  Institute of Neurosciences Kolkata  Institute of Neurosciences Kolkata, 185/1, Acharya Jagadish Chandra Bose Road, Park Street, Mullick Bazaar, Kolkata, West Bengal 700 017, India
Kolkata
WEST BENGAL 		 9874645445

rishi_medicine@yahoo.com 
Dr Annu Aggarwal  Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Medical Research department, 2nd floor,Rao Saheb Achutrao Patwardhan Marg, Four Bungalows, Andheri West, Mumbai - 400053
Mumbai (Suburban)
MAHARASHTRA 		 9320192277
02230972030
annu.aggarwal@relianceada.com 
Dr Sumitabh Gupta  M. V. Hospital and Research Centre  314/30, Mirza Mandi, Chowk, Lucknow – 226003, Uttar Pradesh, India
Lucknow
UTTAR PRADESH 		 7985349437
05224016051
drsumit.tmu@gmail.com 
Dr Sushruth Vinaya Kumar  Santosh Hospital  6/1, Promenade Road, Near Coles Park, Bengaluru - 560005
Bangalore
KARNATAKA 		 7760420485
08040848866
v.sushruth@gmail.com 
Dr Anshu Rohatgi  Sir Ganga Ram Hospital  Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi – 110060, India
North East
DELHI 		 9810159406
01145041726
rohatgianshu@yahoo.com 
Dr Rajesh Iyer  Vikram Hospital Private Limited  Neurology department,1st floor,#71/1,Millers Road, Opposite to St. Annes college, Bengaluru - 560052
Bangalore
KARNATAKA 		 08071004500

rajeshbiyer@gmail.com 
Dr Jaydip Ray Chaudhuri  Yashoda Hospital  Department of Neurology,1st floor,RajBhavan Road, Somajiguda, Hyderabad-500082,Telangana State, India
Hyderabad
ANDHRA PRADESH 		 09849007975
4023414613
jaydiprc@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Dr. Anil Ramakrishna - Bhagwan Mahaveer Jain Hospital, Human Ethics Committee  Approved 
Dr. Annu Aggarwal - Institutional Scientific & Ethics Board, Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  Approved 
Dr. Anshu Rohatgi - Sir Ganga Ram Hospital Ethics Committee  Approved 
Dr. Debashish Chakraborty - Fortis Hospital Ethics Committeee  Approved 
Dr. Guruprasad Hosurkar - Institution Ethics Committee, Columbia Asia Referral Hospital  Approved 
Dr. Hrishikesh Kumar- Institute of Neurosciences Kolkatta-Institutional Ethics Commitee  Approved 
Dr. Jaydip Ray Chaudhuri - Institutional Ethics Committee, Yashoda Hospital  Approved 
Dr. Kishalaya Karan- Institutional Ethics committee, Apollo Multispecialty hospitals, Kolkata  Approved 
Dr. Malay Kant Singh - Institutional Ethics Committee for M.V. Hospital and Research Centre  Approved 
Dr. Manoj Hunnur - BhaktiVedanta Hospital Ethics Committee  Approved 
Dr. Rajesh Iyer - Vikram Hospital Pvt Ltd Bengaluru Ethics Committee  Approved 
Dr. Sushruth Vinaya Kumar - Institutional Ethics Committee of Santosh Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Severe dementia of the Alzheimer’s type,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Rivastigmine 27 mg -15 cm2 transdermal patch   This is a multicenter, prospective, phase IV study evaluating safety, tolerability and effectiveness of rivastigmine 27 mg -15 cm2 transdermal patch prescribed in patients with severe dementia of the Alzheimer’s type as per discretion of treating physician.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1)Patients willing to participate in the study by providing written informed consent.
2)Patients diagnosed with severe dementia secondary to Alzheimer’s disease (AD)
3)Patient’s prescribed with rivastigmine 27mg -15 cm2 transdermal patch as per discretion of treating physician 
 
ExclusionCriteria 
Details  1)Contraindication as per PI
2)Patients simultaneously participating in other studies 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To obtain safety data in patients with severe dementia of the Alzheimer’s type treated with rivastigmine 27 mg -15 cm2 transdermal patch   Overall study period (from FPFV to LPLV) 
 
Secondary Outcome  
Outcome  TimePoints 
1)To assess patients compliance to study medication
2)To assess the skin tolerability
3)To assess the proportion of patients with UTI
4)To evaluate treatment effect by rivastigmine 27 mg -15 cm2 transdermal patch by assessing the changes in MMSE
5)To evaluate treatment efficacy by rivastigmine 27 mg -15 cm2 transdermal patch by assessing the changes in ADCS-Activities of Daily Living Inventory – Severe Impairment Version (ADCS-ADL SIV) Score

 		 During 16 weeks treatment period 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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   Phase 4 
Date of First Enrollment (India)   30/04/2018 
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="2"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Publication will be done in November 2021 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The present phase IV study is mandated by Indian health authority (HA) as a part of conditional approval to market authorization of rivastigmine 27 mg -15 cm2 transdermal patch for treatment of severe dementia secondary to Alzheimer’s disease (AD). The HA mandated phase IV study in their approval letter. Due to non- availability of Indian data for rivastigmine 27 mg -15 cm2 transdermal patch in severe dementia secondary to Alzheimer’s disease (AD) patients, marketing authorization of the same has been granted condition to phase IV study. As per HA letter, interventional study is to be conducted.

Thus the present 16 week study will be conducted to evaluate safety, tolerability and effectiveness in patients with severe dementia of the Alzheimer’s type exposed to rivastigmine 27 mg -15 cm2 transdermal patch as mandated by HA.


 
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