| CTRI Number |
CTRI/2024/09/074281 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess the memory enhancing ability of pioglitazone |
|
Scientific Title of Study
|
Efficacy and safety of pioglitazone in improving cognitive
function among patients with impaired cognition as an add on
therapy- a double blind randomized controlled study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ian Osoro Nyakina |
| Designation |
Research Scholar |
| Affiliation |
SRM Institute of Science and Technology, Kattankulathur |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
in4453@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muhasaparur Ganesan Rajanandh |
| Designation |
Professor |
| Affiliation |
SRM Institute of Science and Technology, Kattankulathur |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
7598464723 |
| Fax |
|
| Email |
mgr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Robert Wilson |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre, Kattankulathur – 603203, Tamil Nadu, India |
| Address |
Department of Neurology, SRM Medical College Hospital and Research Centre, Kattankulathur
Chennai
TAMIL NADU
603203
India |
| Phone |
9952040784 |
| Fax |
|
| Email |
jasonrobby09@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital And Research
Centre, SRM Nagar, Potheri, Chengalpattu,
Tamil Nadu 603203, India |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| D r S Robert Wilson |
SRM Medical College Hospital and Research Centre |
Room No: C4 15, Fourth Floor, Department of Neurology, SRM MCH Department of Neurology
Chennai
TAMIL NADU |
9952040784
jasonrobby09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F028||Dementia in other diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pioglitazone |
15mg Once daily for 6 months |
| Comparator Agent |
Placebo |
Placebo once daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with cognitive impairment (MoCA scale below 26)
Individuals willing to participate in the study
Patients on standard therapy managing their neurological conditions
|
|
| ExclusionCriteria |
| Details |
Patients on insulin medication
Uncontrolled hypertension (SBP above150/90 mm/Hg)
Patients with bladder cancer, kidney, liver and heart complications
Osteoporosis patients or those at high risk of fractures
• Contraindicated medication usage
• The participant has a known history of hypersensitivity to pioglitazone
• Has a history or current diagnosis of macular edema or macular degeneration
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measures will be changes in MoCA Score and amyloid beta 42 40 ratio before and after the treatment. |
Time points will be the 2nd month, 4th month, 6th month and at 12th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be change in EEG-P300 wave, assessment of adverse drug reactions (ADRs), quality of life and medication adherence after every 2 months |
Time points will be the 2nd month, 4th month, 6th month and at 12th month |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
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 2 |
|
Date of First Enrollment (India)
|
07/10/2024 |
| 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="2"
Months="11"
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
|
This study is a randomized, double blind, parallel group, assessing the safety and efficacy of 15mg pioglitazone daily for 6 months in 330 patients with type 2 diabetes and having cognitive decline. It will be conducted in a single center in India. The primary outcome measures will be changes in MoCA Score and Amyloid beta 42 40 ratio at the time points: 2nd month, 4th month, 6th month and 12th month. The secondary outcome will be change in EEG-P300 wave, assessment of adverse drug reactions (ADRs), quality of life and medication adherence using the same time points as stated in primary end point |