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NCT07055958: Metformin Add-on Therapy for Parkinson's Disease
Overview
| Field | Value | |-------|-------| | NCT Number | NCT07055958 | | Title | Metformin Add-on Therapy for Parkinson's Disease | | Status | Recruiting | | Phase | Phase II | | Condition(s) | Parkinson's Disease | | Intervention | Metformin hydrochloride 500mg twice daily + standard Levodopa/Carbidopa | | Sponsor | Bangabandhu Sheikh Mujib Medical University, Bangladesh | | Location | Dhaka, Bangladesh | | Enrollment | 60 patients (estimated) | | Study Duration | 52 weeks |
Study Description
This Phase II clinical trial investigates the efficacy and safety of metformin as an add-on therapy to standard Levodopa/Carbidopa treatment in patients with Parkinson's disease. The study is conducted at Bangabandhu Sheikh Mujib Medical University (BSMMU) in Dhaka, Bangladesh[@bsfmu].
Rationale
Metformin, a widely used antidiabetic medication, has shown significant neuroprotective potential in preclinical models of Parkinson's disease through multiple mechanisms:
AMPK Activation: Metformin activates AMP-activated protein kinase (AMPK), which promotes autophagy and enhances clearance of alpha-synuclein aggregates[@metforminautophagy2022]
Mitochondrial Protection: The drug improves mitochondrial function, reduces oxidative stress, and protects dopaminergic neurons from degeneration[@metforminpd2021]
Anti-inflammatory Effects: Metformin reduces neuroinflammation by modulating microglial activation and decreasing pro-inflammatory cytokines
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NCT07055958: Metformin Add-on Therapy for Parkinson's Disease
Overview
| Field | Value | |-------|-------| | NCT Number | NCT07055958 | | Title | Metformin Add-on Therapy for Parkinson's Disease | | Status | Recruiting | | Phase | Phase II | | Condition(s) | Parkinson's Disease | | Intervention | Metformin hydrochloride 500mg twice daily + standard Levodopa/Carbidopa | | Sponsor | Bangabandhu Sheikh Mujib Medical University, Bangladesh | | Location | Dhaka, Bangladesh | | Enrollment | 60 patients (estimated) | | Study Duration | 52 weeks |
Study Description
This Phase II clinical trial investigates the efficacy and safety of metformin as an add-on therapy to standard Levodopa/Carbidopa treatment in patients with Parkinson's disease. The study is conducted at Bangabandhu Sheikh Mujib Medical University (BSMMU) in Dhaka, Bangladesh[@bsfmu].
Rationale
Metformin, a widely used antidiabetic medication, has shown significant neuroprotective potential in preclinical models of Parkinson's disease through multiple mechanisms:
AMPK Activation: Metformin activates AMP-activated protein kinase (AMPK), which promotes autophagy and enhances clearance of alpha-synuclein aggregates[@metforminautophagy2022]
Mitochondrial Protection: The drug improves mitochondrial function, reduces oxidative stress, and protects dopaminergic neurons from degeneration[@metforminpd2021]
Anti-inflammatory Effects: Metformin reduces neuroinflammation by modulating microglial activation and decreasing pro-inflammatory cytokines
Blood-Brain Barrier Penetration: Metformin has demonstrated ability to cross the BBB and exert direct effects on brain cells
Hypotheses
Primary: Metformin add-on therapy will improve motor symptoms (MDS-UPDRS Part III) compared to Levodopa/Carbidopa alone
Secondary: Metformin will reduce non-motor symptoms and improve quality of life measures
Study Design
Inclusion Criteria
Diagnosis of idiopathic Parkinson's disease (UK Brain Bank criteria)
Hoehn & Yahr stage 2-3
On stable Levodopa/Carbidopa therapy for ≥3 months
Age 40-75 years
Ability to provide informed consent
Exclusion Criteria
Diabetes mellitus (prior or current)
Severe renal or hepatic impairment
Previous metformin use
History of lactic acidosis
Cognitive impairment (MMSE <24)
Treatment Arms
| Arm | Intervention | Description | |-----|--------------|-------------| | Active | Metformin 500mg BID + Levodopa/Carbidopa | Experimental arm | | Control | Placebo + Levodopa/Carbidopa | Standard of care |
Outcome Measures
Primary Outcomes
Change in MDS-UPDRS Part III (motor) score at 52 weeks
Change in "Off" time (hours) via patient diary
Secondary Outcomes
Non-motor symptom assessment (NMSS)
Quality of life (PDQ-39)
MoCA (cognitive function)
Hospital Anxiety and Depression Scale (HADS)
Adverse events and safety monitoring
Mechanism of Action in Parkinson's Disease
Metformin exerts neuroprotective effects through several interconnected pathways:
Lactic acidosis (contraindicated in renal impairment)
Vitamin B12 deficiency (long-term use)
Hypoglycemia (when combined with insulinsecretagogues)
Monitoring Requirements
Baseline renal function (eGFR)
Liver function tests
Fasting glucose
Vitamin B12 levels (if prolonged use)
Institutional Context
Bangabandhu Sheikh Mujib Medical University (BSMMU)
BSMMU is Bangladesh's premier medical research institution, located in Dhaka. The university conducts clinical research across multiple therapeutic areas, including neurology and neurodegenerative diseases. This trial represents an important effort to bring innovative therapeutic approaches to patients in South Asia.
Relevance to Global PD Research
This trial addresses several key questions:
Repurposing Potential: Can an established diabetes drug provide disease-modifying benefits in PD?
Population Diversity: Does the neuroprotective effect generalize to South Asian populations?
Combination Therapy: Is metformin + Levodopa superior to Levodopa alone?
Future Directions
Positive results from this trial could:
Establish metformin as a low-cost neuroprotective option for PD
Inform larger Phase 3 trials in diverse populations
Support combination therapy approaches
Provide evidence for metformin use in early PD
References
[NCT07055958: Metformin add-on to Levodopa for Parkinson's Disease](https://clinicaltrials.gov/study/NCT07055958)
[Metformin and Parkinson's disease: a potential disease-modifying therapy (2023)](https://doi.org/10.1038/s41531-023-00456-8)
[Metformin: a potential neuroprotective agent in Parkinson's disease (2022)](https://doi.org/10.1016/j.arr.2022.101596)
[Metformin prevents dopaminergic neuron death through AMPK activation (2021)](https://doi.org/10.1016/j.nbd.2021.105238)
[Bangabandhu Sheikh Mujib Medical University](https://www.bsmmu.edu.bd)
Related Pages
[Metformin for Neurodegeneration](/therapeutics/metformin-neurodegeneration)