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 Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- The primary outcome measures will be changes in MoCA Score and amyloid beta 42 40 ratio before and after the treatment.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 50.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with cognitive impairment (MoCA scale below 26) Individuals willing to participate in the study Patients on standard therapy managing their neurological conditions.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The primary outcome measures will be changes in MoCA Score and amyloid beta 42 40 ratio before and after the treatment.
Time Frame: Time points will be the 2nd month, 4th month, 6th month and at 12th month
Secondary Outcomes
- 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)
Investigators
Ian Osoro Nyakina
SRM Institute of Science and Technology, Kattankulathur